title: A Phase 3, Randomized, Open-label, Multicenter Study of the Efficacy and Safety of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Harboring a HER2 Exon 20 Mutation Who Progressed on or After Treatment With Platinum Based Chemotherapy

summary: This is a randomized, positive-controlled, open-label, international multicenter, Phase 3 clinical study to compare the efficacy and safety of pyrotinib versus docetaxel in patients with advanced non-squamous NSCLC harboring a HER2 exon 20 mutation who failed platinum based chemotherapy.

lead_sponsor: Jiangsu HengRui Medicine Co., Ltd.

location_country:
Poland
Taiwan
Spain
Italy
Russian Federation
Australia
Korea, Republic of
United States
France
China
Turkey
Belgium
Germany

location_facility: The affiliated hospital of inner mongolia medical univerity

location_facility: Seoul St. Mary's Hospital, The Catholic University of Korea

location_facility: University of California (UC) Davis Comprehensive Cancer Center

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine

location_facility: The First Affiliated Hospital of Guangdong Pharmaceutical University

location_facility: Arkhangelsk Clinical Oncological Dispensary

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

location_facility: General Hospital of Tianjin Medical University

location_facility: Harbin Medical University Cancer Hospital

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: the Second Affiliated Hospital of Anhui Medical University

location_facility: Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)

location_facility: Cangzhou Hospital of Integrated Tcm-Wm.Hebei

location_facility: Centre Hospitalier Intercommunal Creteil

location_facility: David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

location_facility: Florida Cancer Specialists North Divisio

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Shandong Cancer Hospital Affiliated to Shandong University

location_facility: Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

location_facility: The second affiliated hospital of ChongQing medical university

location_facility: Linkou Chang Gung Memorial Hospital (CGMHLK)

location_facility: Severance Hospital, Yonsei University Health System

location_facility: ASST dei Sette Laghi-Ospedale di Circolo e Fondazione Macchi di Varese

location_facility: Clinical hospital RZD-Medicine of St. Petersburg

location_facility: Baskent University Adana Application and Research Center

location_facility: The First Affiliated Hospital，ZheJiang University

location_facility: First Affiliated Hospital of ZhengzhouUniversity

location_facility: University of Kansas Medical Center (KUMC)

location_facility: Necmettin Erbakan University Selcuklu Faculty of Medicine

location_facility: Sir Run Run Shaw Hospital ZheJiang University School Of Medicine

location_facility: The Second Affiliated of Nanchang University

location_facility: Seoul National University Bundang Hospital

location_facility: Subei People's Hospital of Jiangsu Province

location_facility: Hospital Regional Universitario de Malaga

location_facility: Shanghai Pulmonary Hospital, Tongji University

location_facility: Petrov National Medical Research Center of Oncology

location_facility: Florida Cancer Specialists South Divisio

location_facility: beijing chest hospital,Capital medical university

location_facility: University of California - Irvine Medical Center

location_facility: Pius-Hospital Oldenburg, Centre of Radiotherapy and Medical Oncology, Dept. Medical Oncology

location_facility: Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico


type: Other Identifier

type: EudraCT Number

title: TREATMENT RESISTANCE FOLLOWING ANTI-CANCER THERAPIES (TRANSLATE)

summary:
The TRANSLATE study aims to better understand why tumors become resistant to standard anti-cancer therapies.

New tumor biopsy and blood samples are collected after disease progression on standard-of-care anti-cancer treatment and compared to the initial (archival) tumor biopsy sample taken from the same patient.

Annotated reports of results from clinical Next Generation Sequencing (NGS) gene panel tests of both tumor and blood are sent directly from the testing lab to the study physician for discussion with the patient during the study.

Patients may participate in interventional treatment clinical trials at the same time as participating in the TRANSLATE study.

Primary data will be publicly available after the study to support further research.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Other

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
United Kingdom
Argentina
United States
France
Belgium

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center

location_facility: Grand Hôpital de Charleroi - Site Notre Dame

location_facility: Centro de Educacion Medica e Investigaciones Clinicas"Norberto Quirno" CEMIC

location_facility: UCI Medical Center-Chao Family Comprehensive Cancer Center

location_facility: Hôpitaux Civils de Colmar, Centre Hospitalier Louis Pasteur

location_facility: The Oncology Institute of Hope and Innovation

location_facility: The Oncology Institute of Hope Innovation

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Randomized, Double-blind, Placebo-controlled Phase IIB Study Evaluating the Efficacy of Mesdopetam on Daily ON-time Without Troublesome Dyskinesia in Patients With Parkinson's Disease

summary: This is a Phase 2b study investigating the efficacy and safety of mesdopetam as adjunct therapy on daily ON-time without troublesome dyskinesia in patients with Parkinson disease. Mesdopetam is taken for 84 days.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Becanovic K, Vittoria de Donno M, Sousa VC, Tedroff J, Svenningsson P. Effects of a Novel Psychomotor Stabilizer, IRL790, on Biochemical Measures of Synaptic Markers and Neurotransmission. J Pharmacol Exp Ther. 2020 Jul;374(1):126-133. doi: 10.1124/jpet.119.264754. Epub 2020 May 1.

ReferenceCitation: Waters S, Sonesson C, Svensson P, Tedroff J, Carta M, Ljung E, Gunnergren J, Edling M, Svanberg B, Fagerberg A, Kullingsjö J, Hjorth S, Waters N. Preclinical Pharmacology of [2-(3-Fluoro-5-Methanesulfonyl-phenoxy)Ethyl](Propyl)amine (IRL790), a Novel Dopamine Transmission Modulator for the Treatment of Motor and Psychiatric Complications in Parkinson Disease. J Pharmacol Exp Ther. 2020 Jul;374(1):113-125. doi: 10.1124/jpet.119.264226. Epub 2020 May 1.

ReferenceCitation: Svenningsson P, Johansson A, Nyholm D, Tsitsi P, Hansson F, Sonesson C, Tedroff J. Safety and tolerability of IRL790 in Parkinson's disease with levodopa-induced dyskinesia-a phase 1b trial. NPJ Parkinsons Dis. 2018 Dec 6;4:35. doi: 10.1038/s41531-018-0071-3. eCollection 2018.

ipd_sharing: No

lead_sponsor: Integrative Research Laboratories AB

location_country:
Poland
Serbia
Italy
United States
Israel
France

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: CHU Charles Nicolle; Service de Neurologie

location_facility: University Clinical Center of Serbia, Clinic for Neurology

location_facility: Rambam Health Care Campus, Department of Neurology

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: The Chaim Sheba Medical Centre, Department of Neurology

location_facility: Tel Aviv Sourasky Medical Centre; Movement Disorders Unit

location_facility: Clinical Hospital Center Zvezdara, Clinical department of Neurology

location_facility: Rabin Medical Centre - Beilinson Hospital, Department of Neurology

location_facility: Parkinson's Disease and Movement Disorders Center of Silicon Valley

location_facility: Hadassah University Hospital-Ein Kerem, Department of Neurology

location_facility: Elias Research Associates (Allied Biomedical Research Institute)

location_facility: AOU San Giovanni di Dio e Ruggi d'Aragona, Clinica Neurologica

location_facility: University Clinical Center Kragujevac, Clinic for Neurology (Site 602)

location_facility: The Movement Disorder Clinic of Oklahoma

location_facility: University of Texas Southwestern Medical Center

location_facility: University Clinical Center Kragujevac, Clinic for Neurology (Site 601)

location_facility: Colorado Springs Neurological Associates

location_facility: University of Kentucky, Department of Neurology

location_facility: Collaborative Neuroscience Research (CNS Research)

intervention_type: Drug

status_simplified: Ongoing


title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Diabetic Macular Edema

acronym: Rhone-X

summary: This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
United Kingdom
United States
Peru
Japan
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Singapore
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Taiwan
Thailand
Korea, Republic of
France

location_facility: Northern California Retina Vitreous Associates

location_facility: Spec. Ophth. Hospital for Active Treatment- Academic Pashev

location_facility: Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde

location_facility: Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria

location_facility: Fisabio-Ofalmologia Medica; Servicio de Oftalmología

location_facility: University Health Network Toronto Western Hospital

location_facility: Medizinische Hochschule Hannover, Klinik für Augenheilkunde

location_facility: Queen Mary Hospital; Department of Ophthalmology

location_facility: Hospital de Braga; Servico de Oftalmologia

location_facility: Centres Ophtalmologique St Exupéry; Ophtalmologie

location_facility: Klinikum rechts der Isar der TU München; Augenklinik

location_facility: "Intersec. Research and Technology Complex "Eye Microsurgery" n a Fyodorov Irkutsk branch

location_facility: Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Szemészeti Osztály

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Southern California Permanente Medical Group

location_facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

location_facility: Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin

location_facility: Hospital Universitario de Gran Canaria; Servicio de oftalmologia

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Complejo Hospitalario de Navarra; Servicio de oftalmologia

location_facility: Ankara Baskent University Medical Faculty; Department of Ophthalmology

location_facility: Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

location_facility: Kocaeli Üniversitesi Tıp Fakültesi; Department of Ophthalmology

location_facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

location_facility: University Retina and Macula Associates, PC

location_facility: Cleveland Clinic Foundation; Cole Eye Institute

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET; Intezeti Gyogyszertar

location_facility: Retina Consultants of Southern California

location_facility: Specjalistyczny Ośrodek Okulistyczny Oculomedica

location_facility: AIBILI - Association for Innovation and Biomedical Research on Light

location_facility: Beyoglu Goz Training and Research Hospital; Department Of Ophthalmology

location_facility: VISSUM Instituto Oftalmológico de Alicante

location_facility: University of Colorado; dept of ophthalmology

location_facility: University of Utah; Division of Gastroenterology/Hepatology

location_facility: Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

location_facility: Universitätsklinikum Würzburg, Augenklinik und Poliklinik

location_facility: Augenabteilung am St. Franziskus-Hospital

location_facility: Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde

location_facility: Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

location_facility: Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

location_facility: Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow

location_facility: Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde

location_facility: Irccs Ospedale San Raffaele;U.O. Oculistica

location_facility: The Ohio State University Havener Eye Institute

location_facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

location_facility: Ankara University Medical Faculty; Department of Ophthalmology

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Centro de Oftalmologia Barraquer; Servicio Oftalmologia

location_facility: Beetham Eye Institute, Joslin Diabetes Center

location_facility: California Retina Consultants - Santa Maria

location_facility: Faculty Hospital Ostrava; Ophthalmology clinic

location_facility: Chang Gung Medical Foundation - Linkou; Ophthalmology

location_facility: Maharaj Nakorn ChiangMai Hospital; Ophthalmology Department

location_facility: California Eye Specialists Medical group Inc.

location_facility: Rajavithi Hospital; Ophthalmology Department

location_facility: Ospedale Classificato Equiparato Sacro Cuore - Don Calabria; Dipartimento Oculistica

location_facility: Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina; Klinika Okulistyki

location_facility: St. Michael's Hospital; Department of Ophthalmology

location_facility: Ege University Medical Faculty; Department of Ophthalmology

location_facility: National Taiwan University Hospital; Ophthalmology

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: "Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch

location_facility: Taipei Veterans General Hospital; Ophthalmology

location_facility: Hacettepe University Medical Faculty; Department of Ophthalmology

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia

location_facility: Shiga University Of Medical Science Hospital

location_facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

location_facility: Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia

location_facility: Medical Center for Eye Health - Focus Ltd

location_facility: Southeastern Retina Associates Chattanooga

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica

location_facility: Specialized Hospital for Active Treatment of Eye Diseases Zora

location_facility: Prairie Eye & LASIK Center / Prairie Retina Center

location_facility: Seoul National University Bundang Hospital

location_facility: National Defense Medical College Hospital

location_facility: Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: King Chulalongkorn Memorial Hospital; Ophthalmology Department

location_facility: University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Semmelweis Egyetem Szemészeti Vizsgálóhely

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: National University Hospital; Ophthalmology Department

location_facility: VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

location_facility: Hanusch Krankenhaus; Abteilung für Augenkrankheiten mit Augen-Tagesklinik

location_facility: Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia

location_facility: Hospital dos de maig; servicio de oftalmologia

location_facility: Pentagram Eye Hospital (Medical Center "Pentagram")

location_facility: Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL

location_facility: James Paget University Hospitals NHS Foundation Trust

location_facility: Hospital de Santa Maria; Servico de Oftalmologia

location_facility: Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia

location_facility: FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences

location_facility: UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

location_facility: Intersec Research and Technology Complex "Eye Microsurgery" n.a. S.N. Fyodorov; Cheboksary Branch

location_facility: Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Selcuk University Faculty of Medicine; Department Of Ophthalmology

location_facility: LMU Klinikum der Universität, Augenklinik

location_facility: Tan Tock Seng Hospital; Ophthalmology Department

location_facility: FN Hradec Králové, Oční klinika; Ophthalmology clinic

intervention_type: Other


status: Recruiting

intervention_type: Biological

title: A Phase 2, Randomized, Open-label Three-arm Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) That Have Progressed After Platinum Therapy and Immunotherapy (PD-1/PD-L1 Inhibitors) (LEAP-009)

lead_sponsor: Merck Sharp & Dohme LLC

source: euctr

ReferenceType: derived

ReferenceCitation: Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.

enrollment_type: Anticipated

location_country:
Denmark
Taiwan
Portugal
Spain
United Kingdom
Australia
Canada
Korea, Republic of
United States
France
Israel
Romania
Norway

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0601)

location_facility: Mid Florida Hematology and Oncology Center ( Site 1606)

location_facility: VA Ann Arbor Healthcare System ( Site 1584)

location_facility: Perlmutter Cancer Center at Winthrop Oncology Hematology Associates NYU Langone Health ( Site 1597)

location_facility: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C

location_facility: University Hospital Southampton NHS Foundation Trust ( Site 0905)

location_facility: Hospital General de Valencia ( Site 0703)

location_facility: The Center For Cancer And Blood Disorders ( Site 1569)

location_facility: Mid North Coast Cancer Institute ( Site 0109)

location_facility: National Cheng Kung University Hospital ( Site 1202)

location_facility: Hematology Oncology Associates of Fredericksburg ( Site 1537)

location_facility: University Hospital Cleveland ( Site 1578)

location_facility: Soroka Medical Center-Oncology ( Site 0604)

location_facility: Severance Hospital Yonsei University Health System ( Site 1800)

location_facility: Centro Oncologico de Galicia ( Site 0706)

location_facility: Chang Gung Memorial Hospital - Linkou Branch ( Site 1203)

location_facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 0510)

location_facility: Yale-New Haven Hospital-Yale Cancer Center ( Site 1505)

location_facility: Gallipoli Medical Research Foundation-GMRF CTU ( Site 0105)

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1521)

location_facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 1706)

location_facility: China Medical University Hospital ( Site 1205)

location_facility: Inova Schar Cancer Institute ( Site 1550)

location_facility: Medical College of Wisconsin Clinical Cancer Center ( Site 1574)

location_facility: Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0509)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 1555)

location_facility: Penn State Hershey Medical Center ( Site 1561)

location_facility: Seoul National University Bundang Hospital ( Site 1801)

location_facility: Medical University of South Carolina ( Site 1579)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 0909)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1400)

location_facility: Barbara Ann Karmanos Cancer Institute ( Site 1566)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1508)

location_facility: Oslo universitetssykehus, Radiumhospitalet ( Site 1102)

location_facility: Hospital Virgen de la Victoria ( Site 0702)

location_facility: UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)

location_facility: Chang Gung Medical Foundation - Kaohsiung ( Site 1204)

location_facility: Georgia Cancer Center at Augusta University ( Site 1575)

location_facility: Centro Hospitalar Vila Nova de Gaia. Espinho EPE ( Site 1401)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 1523)

location_facility: Washington University School of Medicine ( Site 1500)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1702)

location_facility: Rigshospitalet University Hospital Copenhagen ( Site 1000)

location_facility: Taipei Veterans General Hospital ( Site 1201)

location_facility: Laura and Isaac Perlmutter Cancer Center ( Site 1582)

location_facility: Norton Hospital-Norton Cancer Institute - Downtown ( Site 1601)

location_facility: Guy s and St Thomas Hospital NHS Foundation Trust ( Site 0903)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0700)

location_facility: University of Maryland Greenebaum Cancer Center ( Site 1522)

location_facility: Rush University Medical Center ( Site 1560)

location_facility: University Of Nebraska Medical Center ( Site 1570)

location_facility: University of Kansas Cancer Center ( Site 1538)

location_facility: Centre de Cancerologie du Grand Montpellier ( Site 0508)

location_facility: The Christie NHS Foundation Trust ( Site 0907)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0602)

location_facility: National Taiwan University Hospital ( Site 1200)

location_facility: Hospital Universitari Vall d Hebron ( Site 0701)

summary: This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review.


title: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments

acronym: DELIVER

summary: Evaluation of eptinezumab in the prevention of migraine in participants with unsuccessful prior preventive treatments.

status: Completed

ReferenceCitation: Ashina M, Lanteri-Minet M, Pozo-Rosich P, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B. Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2022 Jul;21(7):597-607. doi: 10.1016/S1474-4422(22)00185-5.

lead_sponsor: H. Lundbeck A/S

location_country:
Denmark
Poland
Spain
Italy
Georgia
Russian Federation
United Kingdom
Finland
Sweden
Hungary
United States
France
Belgium
Germany
Bulgaria
Slovakia
Czechia

location_facility: Azienda Ospedaliera - Universitaria Sant' Andrea

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Synexus Midlands Clinical Research Centre

location_facility: Clinica Universidad de Navarra - Pamplona

location_facility: Neurologie, MP-neuro s.r.o., poliklinika Modry pavilon

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Lynn Health Science Institute - Oklahoma City

location_facility: Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

location_facility: Neurologicka ambulancia MUDr. Dupejova s.r.o.

location_facility: Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

location_facility: Northern Care Alliance NHS Foundation Trust

location_facility: IRCCS Istituto Delle Scienze Neurologiche di Bologna

location_facility: Multiprofile Hospital for Active Treatment Heart and Brain EAD

location_facility: Centre Hosptitalier Universitaire d'Angers

location_facility: Northwest Clinical Research Center (NWCRC)

location_facility: Medicínske Centrum Konzílium - Dubnica nad Vahom

location_facility: Helsicore - Israeli-Georgian Medical Research Clinic

location_facility: Clinical Research Institute Inc. - Minneapolis

location_facility: Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Michigan Headache and Neurological Institute

location_facility: Hometown Urgent Care & Occupational Health/Hometown Research - Huber Heights

location_facility: Synexus - Scotland Clinical Research Centre

location_facility: Synexus - Thames Valley Clinical Research Centre

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana

location_facility: Clinical Neuroscience Solutions - Memphis

location_facility: Malkhaz Katsiashvili Multiprofile Emergency Center

location_facility: Indywidualna Praktyka Lekarska dr hab. n. med. Anna Szczepanska-Szerej

location_facility: Synexus - Merseyside Clinical Research Centre

location_facility: Assistance Publique Hôpitaux de Marseille

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Migräne- und Kopfschmerzklinik Königstein

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

location_facility: Hospital Alvaro Cunqueiro - Clinico Universitario Vigo

location_facility: First Multiprofile Hospital for Active Treatment - Sofia

location_facility: Concept Medica Trials Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz

location_facility: MUDr. Helena Hojdíkova s.r.o. Neurologicka Ambulance

location_facility: Archangel Saint Michael Multiprofile Clinical Hospital

location_facility: Synexus - Manchester Clinical Research Centre

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Simon Khechinashvili University Hospital

status_simplified: Completed


title: A Randomized, Open-label, Multi-arm, Two-part, Phase II Study to Assess Efficacy and Safety of Multiple LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic BRAFV600 or NRAS Mutant Melanoma

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Moschos SJ. War against NRAS-Mutant Melanoma Using Targeted Therapies Remains Challenging. Clin Cancer Res. 2022 Jul 15;28(14):2977-2979. doi: 10.1158/1078-0432.CCR-22-1256.

ipd_sharing_description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

location_country:
United Kingdom
Italy
Australia
Netherlands
Argentina
Switzerland
United States
France
Israel
Belgium
Norway
Germany

location_facility: The Angeles Clinic and Research Institute

location_facility: Massachusetts General Hospital Massachusetts General Hospital

location_facility: H Lee Moffitt Cancer Center and Research Institute Moffitt McKinley Outpatient Ct

location_facility: NYU Laura and Isaac Perlmutter Cancer Center

location_facility: University of TX MD Anderson Cancer Center

location_facility: Florida Cancer Specialists Sarasota Office

location_facility: Dana Farber Cancer Institute Dept.of DFCI

summary: The primary purpose of this study is to evaluate the efficacy of LXH254 combinations in previously treated unresectable or metastatic melanoma


title: Safety and Efficacy of Inhaled Pegylated Adrenomedullin (PEG-ADM) in Patients Suffering From Acute Respiratory Distress Syndrome (ARDS): a Double-blind, Randomized, Placebo-controlled, Multicenter Phase 2a/b Clinical Trial

acronym: SEAL

summary: The study is composed of two parts. In part A of the study two active doses of inhaled pegylated adrenomedullin (PEG-ADM) will be compared regarding safety and efficacy to a substance that has no therapeutic effect (placebo) in order to find an optimal and safe of the study drug. In part B of the study the highest dose that is considered safe and has demonstrated efficacy will be taken forward to collect information how well patients suffering from Acute Respiratory Distress Syndrome (ARDS) respond to treatment with inhaled pegylated adrenomedullin (PEG-ADM) compared to treatment with placebo. ARDS is a type of lung failure that cause fluid to build up in the lungs making breathing difficult or impossible.

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

lead_sponsor: Bayer

location_country:
Spain
Italy
United Kingdom
Romania
Belgium
Czechia
Portugal
Austria
Russian Federation
Israel
Slovakia
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Greece
Ireland
Finland
Korea, Republic of
France
Netherlands

location_facility: First City Clinical Hospital n.a. E.E. Volosevich

location_facility: Klinikum der Universität München Grosshadern

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

location_facility: Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

location_facility: Tampereen yliopistollinen sairaala, keskussairaala

location_facility: Spitalul Clinic Judetean de Urgenta "Pius Brinzeu" Timisoara

location_facility: Pulmonary & Critical Care Seoul National University Boramae

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: Aalborg Universitetshospital, Anesthesiology dept.

location_facility: Hôpital Cantonal Universitaire de Genève

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Centre intégré universitaire du Nord de l'île de Montréal- H

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Severance Hospital, Yonsei University Health System

location_facility: SOTIRIA General Hospital of Chest Diseases

location_facility: Ciutat Sanitària i Universitària de Bellvitge

location_facility: Klinikum der Stadt Köln gGmbH - Krankenhaus Merheim

location_facility: General Hospital of Athens "Evangelismos"

location_facility: Centre Hospitalier Universitaire - Angers

location_facility: Seoul National University Bundang Hospital

location_facility: Sjællands Universitetshospital Køge - Anesthesiological Dept

location_facility: Vancouver Island Health Authority - Royal Jubilee Hospital

location_facility: Kingston Health Sciences Centre (KGH Site)

location_facility: CIUSSS de l'Est-de-l'Ile de Montreal,Installation Maisonneuv

location_facility: Fakultna Nemocnica s poliklinikou F.D.Roosevelta

location_facility: University General Hospital of Heraklion

location_facility: Sci-Res. Institute of Emergency Care n.a. N.V. Sklifosovsky

location_facility: Sp. Univ. de Urgenta Militar Central Dr. Carol Davila


title: A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Denmark
Poland
Taiwan
Spain
United Kingdom
Australia
Switzerland
Korea, Republic of
United States
France
China
Puerto Rico
Belgium
Germany

location_facility: Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: St James's Institute of Oncology; Dept of Haematology

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

location_facility: Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku

location_facility: PanOncology Trials; Hospital Oncológico, Puerto Rico Medical Center

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Aarhus Universitetshospital Skejby; Blodsygdomme

location_facility: Hopital Henri Mondor; 51 Av Mal Lattre De Tassigny

location_facility: Instytut Hematologii i Transfuzjologii; Klinika Hematologii

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Chang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-Oncology

location_facility: Harbin Medical University Cancer Hospital

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

location_facility: Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: Institut Bergonie; Hematologie Oncologie

location_facility: Katharinenhospital Stuttgart; Klinik für Hämatologie, Onkologie und Palliativmedizin

location_facility: University of Mississippi Medical Center

location_facility: Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology

location_facility: Christie Hospital; Department of Haematology and Transplant

location_facility: Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: UCLH - Clinical Trials Pharmacy B&D Centre

location_facility: Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology

location_facility: Szpital Kliniczny im. Heliodora Święcickiego; Oddzial Hematologii i Transplantacji Szpiku

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: CHU DE MONTPELLIER-ST ELOI; Département d'Hématologie Clinique

summary: This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (Glofit-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.


title: A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy of Adjuvant Durvalumab in Combination With Platinum-based Chemotherapy in Completely Resected Stage II-III NSCLC (MERMAID-1)

summary: This is a Phase III, randomized, parallel-arm, placebo controlled, double blind, multicenter study assessing the efficacy and safety of durvalumab versus placebo following SoC chemotherapy in patients with completely resected stage II-III NSCLC who are MRD+ post surgery

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United States
Peru
Belgium
Japan
Romania
Czechia
Poland
Hong Kong
Russian Federation
Australia
Argentina
India
Israel
Turkey
Mexico
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Thailand
Vietnam
Korea, Republic of
France
Netherlands


title: A Phase III, Randomised, Controlled, Multi-center, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer

acronym: NeoADAURA

summary: This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer

ReferenceCitation: Tsuboi M, Weder W, Escriu C, Blakely C, He J, Dacic S, Yatabe Y, Zeng L, Walding A, Chaft JE. Neoadjuvant osimertinib with/without chemotherapy versus chemotherapy alone for EGFR-mutated resectable non-small-cell lung cancer: NeoADAURA. Future Oncol. 2021 Nov;17(31):4045-4055. doi: 10.2217/fon-2021-0549. Epub 2021 Jul 19.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Japan
Poland
Austria
Russian Federation
India
Israel
Turkey
Mexico
Singapore
Brazil
Canada
Switzerland
China
Germany
Bulgaria
Taiwan
Thailand
Vietnam
Korea, Republic of
France
Chile


title: A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis

lead_sponsor: Vertex Pharmaceuticals Incorporated

ReferenceCitation: Bruggeman LA, Sedor JR, O'Toole JF. Apolipoprotein L1 and mechanisms of kidney disease susceptibility. Curr Opin Nephrol Hypertens. 2021 May 1;30(3):317-323. doi: 10.1097/MNH.0000000000000704. Review.

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent research/clinical-trial-data-sharing.

location_country:
Puerto Rico
United States
United Kingdom
France

location_facility: Service de Nephrologie - Hopital Universitaire Necker

location_facility: Nevada Kidney Disease and Hypertension Centers

location_facility: Hopitaux Universitaires Est Parisien - Hopital Tenon

location_facility: Université Paris-Descartes / Hôpital Européen Georges Pompidou

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Nephrology and Hypertension Associates, LTD

location_facility: Duke University School of Medicine - Duke Molecular Physiology Institute

location_facility: South Carolina Nephrology and Hypertension Center, Inc.

location_facility: Morehouse School of Medicine, Grady Memorial Hospital

location_facility: University Hospitals of Leicester NHS Trust - Leicester General Hospital

location_facility: UNC Kidney Center Division of Nephrology & Hypertension

location_facility: Renal and Transplant Associates of New England, PC

location_facility: King's College Hospital NHS Foundation Trust - Guthrie Clinic

location_facility: University of Alabama at Birmingham - The Kirklin Clinic

location_facility: Kidney and Hypertension Specialists of Miami

location_facility: The George Washington University Medical Faculty Associates - Kidney Disease & Hypertension

location_facility: Paragon Health, PC d/b/a Nephrology Center, PC

summary: This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-147 in subjects with apolipoprotein L1 (APOL1)-mediated focal segmental glomerulosclerosis (FSGS).


title: An Exploratory Phase 1b Open-label Multi-arm Trial to Evaluate the Safety and Efficacy of CC-90009 in Combination With Anti-Leukemia Agents in Subjects With Acute Myeloid Leukemia

summary: CC-90009-AML-002 is an exploratory Phase 1b, open-label, multi-arm trial to evaluate the safety and efficacy of CC-90009 in combination with anti-leukemia agents in participants with acute myeloid leukemia (AML).

design_allocation: Non-Randomized

ReferenceCitation: Surka C, Jin L, Mbong N, Lu CC, Jang IS, Rychak E, Mendy D, Clayton T, Tindall E, Hsu C, Fontanillo C, Tran E, Contreras A, Ng SWK, Matyskiela M, Wang K, Chamberlain P, Cathers B, Carmichael J, Hansen J, Wang JCY, Minden MD, Fan J, Pierce DW, Pourdehnad M, Rolfe M, Lopez-Girona A, Dick JE, Lu G. CC-90009, a novel cereblon E3 ligase modulator, targets acute myeloid leukemia blasts and leukemia stem cells. Blood. 2021 Feb 4;137(5):661-677. doi: 10.1182/blood.2020008676.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_country:
United Kingdom
United States
Canada
France

location_facility: Washington University School of Medicine

location_facility: Washington University School Of Medicine

location_facility: Dana-Farber/Mass General Brigham Cancer Care, Inc

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole


title: A Randomized, Double-blind, Placebo-controlled Phase III Multi-center Study of Azacitidine With or Without MBG453 for the Treatment of Patients With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

ipd_sharing_description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
Lithuania
United States
Belgium
Japan
Czechia
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Malaysia
Singapore
Brazil
Lebanon
Canada
Switzerland
China
Germany
Taiwan
Greece
Oman
Finland
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Northwestern University Div of Hematology/Oncology

location_facility: University of Virginia University of Virginia

location_facility: University of Rochester Medical Center Dept.ofUniv.Rochester/JPWilmot

location_facility: Yale University School of Medicine Smilow Cancer Hospital

location_facility: Weill Cornell Medicine NewYork Presbyterian Hospital

summary:
This is a Phase III multi-center, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to azacitidine in adult subjects with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) who have an indication for treatment with azacitidine in first-line setting and are not eligible for intensive chemotherapy or hematopoietic stem cell transplantation (HSCT) according to medical judgment by the investigator.

The purpose of the current study is to assess clinical effects of MBG453 in combination with azacitidine in adult subjects with IPSS-R intermediate, high, very high risk MDS and CMML-2.


title: Micra AV Transcatheter Pacing System Post-Approval Registry

acronym: Micra AV PAS

summary:
Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release.

The Micra AV Registry is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic

location_country:
Denmark
Portugal
Serbia
Saudi Arabia
Greece
Italy
Netherlands
Slovenia
Canada
Spain
Switzerland
United Kingdom
United States
France
Israel
Malaysia
Belgium
Norway
Germany
Czechia

location_facility: New York-Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Azienda Ospedaliera Sepdali Civili di Brescia

location_facility: University of Pittsburgh Medical Center UPMC Shadyside

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Manchester University NHS Foundation Trust- Manchester Royal Infirmary

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand-Gabriel-Montpied

location_facility: The James Cook University Hospital - South Tees Hospitals NHS

location_facility: King Salman Heart Center - King Fahad Medical City

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz

location_facility: The University of Oklahoma Health Sciences Center

location_facility: Indiana University Health Methodist Research Institute

location_facility: TidalHealth Peninsula Regional Medical Center

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Centre Hospitalier Régional de la Citadelle

location_facility: The Ohio State University Wexner Medical Center

location_facility: Atlantic Health/Morristown Medical Center

location_facility: University of Kansas Medical Center Research Institute

location_facility: Universitätsklinikum Jena - Friedrich Schiller Universität

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: Oklahoma Heart Hospital Research Foundation

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: New York-Presbyterian Hospital/Columbia University Medical Center


title: A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)

type: Registry Identifier

ReferenceCitation: Verset G, Borbath I, Karwal M, Verslype C, Van Vlierberghe H, Kardosh A, Zagonel V, Stal P, Sarker D, Palmer DH, Vogel A, Edeline J, Cattan S, Kudo M, Cheng AL, Ogasawara S, Daniele B, Chan SL, Knox JJ, Qin S, Siegel AB, Chisamore M, Hatogai K, Wang A, Finn RS, Zhu AX. Pembrolizumab Monotherapy for Previously Untreated Advanced Hepatocellular Carcinoma: Data from the Open-Label, Phase II KEYNOTE-224 Trial. Clin Cancer Res. 2022 Jun 13;28(12):2547-2554. doi: 10.1158/1078-0432.CCR-21-3807.

ReferenceCitation: Llovet JM, Vogel A, Madoff DC, Finn RS, Ogasawara S, Ren Z, Mody K, Li JJ, Siegel AB, Dubrovsky L, Kudo M. Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment. Cardiovasc Intervent Radiol. 2022 Apr;45(4):405-412. doi: 10.1007/s00270-021-03031-9. Epub 2022 Feb 4.

ReferenceCitation: Kloeckner R, Galle PR, Bruix J. Local and Regional Therapies for Hepatocellular Carcinoma. Hepatology. 2021 Jan;73 Suppl 1:137-149. doi: 10.1002/hep.31424. Epub 2020 Nov 6. Review.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Japan
Hong Kong
Portugal
Australia
Puerto Rico
Israel
Turkey
Norway
Brazil
Hungary
China
Germany
Denmark
Taiwan
Ireland
New Zealand
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Guangxi Medical University Affiliated Tumor Hospital-Hepatological surgery ( Site 0862)

location_facility: The Ohio State University Wexner Medical Center ( Site 0759)

location_facility: VA Caribbean Healthcare System ( Site 0524)

location_facility: Princess Alexandra Hospital ( Site 0006)

location_facility: BP - A Beneficencia Portuguesa de São Paulo ( Site 0046)

location_facility: Odense Universitetshospital ( Site 0160)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 0669)

location_facility: Centro Hospitalar de Lisboa Central, EPE - Hosp St. Ant dos Capuchos ( Site 0505)

location_facility: Bezmialem Vakf Üniversitesi-Oncology ( Site 0660)

location_facility: Henry Ford Hospital-GI/Hepatology Research ( Site 0735)

location_facility: Centro de Oncología de Precisión-Oncology ( Site 0068)

location_facility: Harbin Medical University Cancer Hospital ( Site 0090)

location_facility: Penn State Hershey Medical Center ( Site 0766)

location_facility: The First Hospital of Kunming ( Site 0124)

location_facility: The University of Tokyo Hospital ( Site 0348)

location_facility: Universitaetsklinikum Leipzig ( Site 0202)

location_facility: Japanese Red Cross Osaka Hospital ( Site 0356)

location_facility: Hospital General Universitario de Valencia ( Site 0595)

location_facility: C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 0180)

location_facility: Saitama Medical University Hospital ( Site 0370)

location_facility: Chinese People s Liberation Army Army Characteristic Medical Center ( Site 0117)

location_facility: Seoul National University Hospital ( Site 0567)

location_facility: Fundacao Dr Amaral Carvalho ( Site 0050)

location_facility: Osaka International Cancer Institute ( Site 0357)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0365)

location_facility: A.P.H. Paris, Hopital Henri Mondor ( Site 0179)

location_facility: University of New Mexico Comprehensive Cancer Center ( Site 0805)

location_facility: Mountain States Tumor Institute ( Site 0773)

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0058)

location_facility: I.E.U. Medical Point Hastanesi ( Site 0649)

location_facility: Inonu Universitesi Medical Fakultesi ( Site 0650)

location_facility: OHSU Center for Health & Healing ( Site 0746)

location_facility: Zala Megyei Szent Rafael Korhaz ( Site 0265)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0503)

location_facility: The Third Affiliated Hospital of Naval Medical University ( Site 0123)

location_facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE-Department of Medical Imaging and Interventional Radiology ( Si

location_facility: Ankara City Hospital-Medical Oncology ( Site 0661)

location_facility: Medizinische Hochschule Hannover ( Site 0200)

location_facility: Mengchao Hepatobiliary Hospital of Fujian Medical University ( Site 0121)

location_facility: Jiangxi Provincial Cancer Hospital-Cancer Hospital ( Site 0134)

location_facility: Seoul National University Bundang Hospital ( Site 0570)

location_facility: Hacettepe University Medical Faculty ( Site 0653)

location_facility: Fujian Provincial Cancer Hospital ( Site 0085)

location_facility: The First Affiliated Hospital of Soochow University ( Site 0120)

location_facility: Leids Universitair Medisch Centrum-Medical Oncology ( Site 0442)

location_facility: National Taiwan University Hospital ( Site 0606)

location_facility: Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0333)

location_facility: Zhujiang Hospital of Southern Medical University ( Site 0115)

location_facility: Centro Hospitalar do Porto, E.P.E. - Hospital Geral de Sto. Antonio ( Site 0504)

location_facility: Westmead Hospital-Gastroenterology & Hepatology ( Site 0009)

location_facility: Kanazawa University Hospital ( Site 0354)

location_facility: Kaohsiung Medical University Hospital ( Site 0611)

location_facility: Taichung Veterans General Hospital ( Site 0613)

location_facility: Hadassah Ein Karem Jerusalem ( Site 0303)

location_facility: Yokohama City University Medical Center ( Site 0351)

location_facility: Administradora Country S.A. ( Site 0137)

location_facility: Nara Medical University Hospital ( Site 0359)

location_facility: Tianjin Third Central Hospital ( Site 0861)

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0334)

location_facility: Azienda USL della Romagna-Dipartimento di Oncologia ed Ematologia ( Site 0332)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0673)

location_facility: UCLA Hematology/Oncology - Santa Monica ( Site 0720)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0305)

location_facility: Kagawa Prefectural Central Hospital ( Site 0364)

location_facility: Nanfang Hospital of Southern Medical University ( Site 0088)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0598)

location_facility: University of Iowa Hospital and Clinics ( Site 0729)

location_facility: National Cheng Kung University Hospital ( Site 0608)

location_facility: Ramathibodi Hospital, Mahidol University ( Site 0628)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 0629)

location_facility: Zhongshan Hospital Fudan University ( Site 0084)

location_facility: Chongqing Three Gorges Central Hospital ( Site 0859)

location_facility: The First Affiliated Hospital of Fujian Medical University ( Site 0089)

location_facility: Maastricht University Medical Centre ( Site 0440)

location_facility: ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0331)

location_facility: Ad-Vance Medical Research LLC ( Site 0527)

location_facility: Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 0654)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 0098)

location_facility: Kyungpook National University Hospital ( Site 0569)

location_facility: National Cancer Center Hospital East ( Site 0347)

location_facility: Fudan University Shanghai Cancer Center ( Site 0106)

location_facility: China Medical University Hospital-Surgical Department ( Site 0610)

location_facility: Aarhus Universitets hospital ( Site 0175)

location_facility: Charite - Universitaetsmedizin ( Site 0204)

location_facility: Hiroshima University Hospital ( Site 0360)

location_facility: Az Osp di Rilievo Nazionale A. Cardarelli ( Site 0329)

location_facility: Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0133)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0744)

location_facility: West China Hospital of Sichuan University ( Site 0119)

location_facility: Oslo Universitetssykehus Ullevål ( Site 0500)

location_facility: Puerto Rico Medical Research Center LLC ( Site 0523)

location_facility: University Medical Center New Orleans ( Site 0733)

location_facility: Edwards Comprehensive Cancer Center ( Site 0786)

location_facility: Universitaetsklinikum Halle ( Site 0213)

location_facility: Toranomon Hospital Kajigaya ( Site 0369)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0609)

location_facility: Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0215)

location_facility: Shalimov s NI of Surgery and Transplantation ( Site 0671)

location_facility: Jichi Medical University Hospital ( Site 0353)

location_facility: St Vincents University Hospital ( Site 0690)

location_facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 0126)

location_facility: USC Norris Comprehensive Cancer Center ( Site 0717)

location_facility: Hospital Clinico San Carlos ( Site 0597)

location_facility: 2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0110)

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico ( Site 0325)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0607)

location_facility: Saga-Ken Medical Centre Koseikan ( Site 0363)

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0345)

location_facility: Scripps Clinic Torrey Pines ( Site 0714)

location_facility: University Hospital, Kyoto Prefectural University of Medicine ( Site 0367)

location_facility: Clinica de Oncologia Reichow ( Site 0052)

location_facility: Royal Marsden NHS Foundation Trust ( Site 0694)

location_facility: Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (

location_facility: Policlinico Universitario -Agostino Gemelli ( Site 0328)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0043)

location_facility: Hunan Provincial People's Hospital ( Site 0113)

location_facility: Juntendo University Hospital ( Site 0371)

location_facility: Arizona Oncology Associates PC- HOPE ( Site 0770)

location_facility: Trakya University Medical Faculty Balkan Oncology Hospital ( Site 0648)

location_facility: Universitaetsklinikum Freiburg ( Site 0199)

location_facility: Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0267)

location_facility: Pusan National University Hospital ( Site 0568)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0207)

location_facility: Peking Union Medical College Hospital ( Site 0087)

location_facility: Chonnam National University Hwasun Hospital ( Site 0572)

location_facility: Centro de Cancer Nuestra Senora de la Esperanza ( Site 0065)

location_facility: Hospital Universitario Puerta de Hierro ( Site 0596)

location_facility: Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0056)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0361)

location_facility: Houston Methodist Research Institute ( Site 0784)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0064)

location_facility: Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0441)

location_facility: University of Cincinnati Medical Center ( Site 0791)

location_facility: Centro Hospitalar e Universitario de Coimbra ( Site 0502)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0108)

location_facility: Xi'an International Medical Center Hospital ( Site 0860)

location_facility: Jinan University - Zhuhai People's Hospital-Intervention Department ( Site 0856)

location_facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0057)

location_facility: University of Kansas Cancer Center ( Site 0731)

location_facility: Fundacion Cardiovascular de Colombia ( Site 0136)

location_facility: Guangdong Provincial People s Hospital ( Site 0100)

location_facility: Konya Necmettin Erbakan University Medical Faculty ( Site 0652)

location_facility: The Catholic University of Korea St. Mary s Hospital ( Site 0571)

location_facility: Erasmus University Medical Center ( Site 0439)

location_facility: Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 0501)

location_facility: Korea University Guro Hospital ( Site 0573)

location_facility: Severance Hospital Yonsei University Health System ( Site 0564)

summary: The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).


title: A Phase Ib/II, Open-Label, Multicenter Study With a Non-Randomized Stage Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab Plus Lenalidomide (+Len), and a Randomized Stage Evaluating the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Patients With Follicular Lymphoma

summary: This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of mosunetuzumab + lenalidomide in participants with follicular lymphoma (FL). This study will also compare the pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity of IV mosunetuzumab + len vs subcutaneous (SC) mosunetuzumab + len.

location_country:
United Kingdom
Spain
United States
France
China

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Complejo Asistencial Universitario de Salamanca

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Centre Hospitalier Lyon Sud; Direction Générale

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Tianjin Medical University Cancer Institute & Hospital


title: Prospective, Open-Label Clinical Study of Andexanet Alfa in Patients Receiving FXa (Activated Factor X) Inhibitor Who Require Urgent Surgery

acronym: Annexa-S

summary: Prospective, open-label clinical trial to evaluate the efficacy and safety of andexanet alfa patients who require urgent surgery that have been anticoagulated with the FXa (activated factor X) inhibitors.

ipd_sharing_description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

lead_sponsor: Alexion Pharmaceuticals

location_country:
Austria
United States
Israel
France
Japan
Germany


title: LIBRETTO-431: A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing Selpercatinib to Platinum-Based and Pemetrexed Therapy With or Without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

lead_sponsor: Loxo Oncology, Inc.

ReferenceCitation: Claerhout S, Lehnert S, Vander Borght S, Spans L, Dooms C, Wauters E, Vansteenkiste J, Weynand B, Deraedt K, Bourgain C, Vanden Bempt I. Targeted RNA sequencing for upfront analysis of actionable driver alterations in non-small cell lung cancer. Lung Cancer. 2022 Apr;166:242-249. doi: 10.1016/j.lungcan.2022.02.013. Epub 2022 Mar 1.

ReferenceCitation: Solomon BJ, Zhou CC, Drilon A, Park K, Wolf J, Elamin Y, Davis HM, Soldatenkova V, Sashegyi A, Lin AB, Lin BK, F Loong HH, Novello S, Arriola E, Pérol M, Goto K, Santini FC. Phase III study of selpercatinib versus chemotherapy ± pembrolizumab in untreated RET positive non-small-cell lung cancer. Future Oncol. 2021 Mar;17(7):763-773. doi: 10.2217/fon-2020-0935. Epub 2020 Nov 5.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Spain
Italy
United Kingdom
Ukraine
Romania
Belgium
Japan
Czechia
Poland
Hong Kong
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Singapore
Brazil
Canada
China
Germany
Taiwan
Greece
Korea, Republic of
France
Netherlands

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: Institut du Cancer de Montpellier - Val d'aurelle

location_facility: First Moscow State Medical University n.a. Sechenov

location_facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

location_facility: Arkhangelsk Clinical Oncological Dispensary

location_facility: Hospital Universitario La Fe de Valencia

location_facility: First affiliated Hospital of Sun Yat-Sen University

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Actualidad Basada en la Investigación del Cáncer

location_facility: Institut Català d'Oncologia (ICO) - Badalona

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center

location_facility: Harbin Medical University Cancer Hospital

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council

location_facility: GBUZ Republican Clinical Oncological Dispensary

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Fundacion CENIT para la Investigacion en Neurociencias

location_facility: St-Petersburg scientifical practical cente spec medical care

location_facility: Soroka Medical Center - Pediatric Outpatient Clinic

location_facility: Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital

location_facility: Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta

location_facility: N.N.Petrov Research Institute of Oncology

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Vrije Universiteit Medisch Centrum Amsterdam

location_facility: Spitalul Universitar de Urgență București

location_facility: Nemocnice AGEL Ostrava-Vitkovice a.s.-Plicni oddeleni

location_facility: Inonu Universitesi Turgut Ozal Tıp Merkezi

location_facility: Hospital General Universitario de Alicante

location_facility: Azienda Ospedlaliero-Univeristaria Pisana, Stabilimento Ospedaliero di Cisanello

location_facility: Instituto de Educação, Pesquisa e Gestão em Saúde

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Sotiria Thoracic Diseases Hospital of Athens

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

location_facility: Spitalul Judetean de Urgenta "Sf. Ioan cel Nou"

location_facility: Izmir Ataturk Training and Research Hospital

location_facility: West China Hospital of Sichuan University

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital Nord

location_facility: Icesp - Instituto Do Câncer Do Estado de São Paulo

location_facility: Seoul National University Bundang Hospital

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: Sumy regional clinical oncological dispensary

location_facility: Samara Regional Clinical Oncology Center

location_facility: CHU Grenoble Alpes- Hopital Albert Michallon

location_facility: The First Affiated Hospital Of Guangzhou Medical Collage

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, "Dnipro State Medical University"

location_facility: Xinjiang Medical University Cancer Hospital

location_facility: University General Hospital of Heraklion

location_facility: Hacettepe University Faculty of Medicine

location_facility: I.F.O. Istituto Nazionale Tumori Regina Elena

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: Chernivtsi Regional Oncological Dispensary

location_facility: Health Pharma Professional Research S.A. de C.V:

location_facility: City Hospital, Nottingham University Hospitals

location_facility: Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology

location_facility: Centro de Oncología e Investigación de Buenos Aires

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Republic Oncology Dispensary of MoH of Republic Tatarstan

location_facility: First Affiliated Hosp of College of Med, Zhejiang University

summary: The reason for this study is to see if the study drug selpercatinib compared to a standard treatment is effective and safe in participants with rearranged during transfection (RET) fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.


acronym: POLARGO

title: A Phase III, Open-Label, Multicenter, Randomized, Study Evaluating the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab Plus Gemcitabine Plus Oxaliplatin (R-GEMOX) Versus R-GEMOX in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Brazil
Spain
Greece
Ireland
Italy
United Kingdom
Finland
Canada
Sweden
Korea, Republic of
United States
France
China
India
Mexico
Turkey
Germany

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Hopital Bretonneau; Hematologie Therapie Cellulaire

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena Ematologia

location_facility: Gemeinschaftsklinikum Mittelrhein gGmbH; Ev. Stift St. Martin

location_facility: Hopital Henri Mondor; 51 Av Mal Lattre De Tassigny

location_facility: Hospital Universitario Dr. Peset; Servicio de Hematologia

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova

location_facility: Laiko General Hospital; Hematology Clinic

location_facility: Universitaetsklinikum Schleswig Holstein - Campus Luebeck; Haematologie, Onkologie

location_facility: The Cancer Institute at St Francis Hospital

location_facility: Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: All India Institute of Medical Sciences ,Institute Rotary Cancer Hospital; Department of Oncology

location_facility: Memorial Sloan Kettering Cancer Center at Bergen

location_facility: West China Hospital - Sichuan University

location_facility: Hospital Universitario de Canarias;servicio de Hematologia

location_facility: St James' Hospital; Cancer Clinical Trials Office

location_facility: Hospital de Especialidades Centro Medico Nacional La Raza; Haematology

location_facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi

location_facility: IHA Hematology Oncology Consultants - Ann Arbor; Michigan Orthopedic Center

location_facility: Niagara Health Systems - St. Catherines General Site; Niagara Health System-St. Catharines Site

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: The 1st Affiliated Hospital of Nanchang Unversity

location_facility: Memorial Cancer Institute at Memorial West

location_facility: Centre Henri Becquerel; Service Hématologie

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica

location_facility: Osp. San Raffaele; Dip. Di Oncoematologia

location_facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

location_facility: Amerikan HAstanesi Onkoloji Birimi Teşvikiye

location_facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

location_facility: Seoul National University Bundang Hospital

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: Istanbul University Cerrahpasa Medical Faculty; Hematology Department

location_facility: Millennium Research & Clinical Development

location_facility: Akdeniz Uni School of Medicine; Hematology

location_facility: Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia

location_facility: Nebraska Cancer Specialists; Oncology Hematology West, PC

location_facility: Guangxi Cancer Hospital of Guangxi Medical University

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Zhujiang Hospital, Southern Medical University

location_facility: McGill University Health Centre - Glen Site

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia

location_facility: Memorial Sloan Kettering Cancer Center at Westchester

location_facility: Abdurrahman Yurtarslan Onkoloji Training and Research Hospital

location_facility: Oncology Hematology Associates - Springfield

location_facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia

location_facility: Centre hospitalier regional de Trois-Rivieres

location_facility: Institute of Hematology and Hospital of Blood Disease

summary: This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study comprises of two stages: a safety run-in stage and a randomized controlled trial.


acronym: SALTO

title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study With Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged >=2 to <18 Years With Pulmonary Arterial Hypertension

lead_sponsor: Actelion

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

location_country:
Croatia
Serbia
Spain
Italy
Lithuania
Ukraine
United States
Belgium
Poland
Portugal
Russian Federation
Australia
Israel
Turkey
Mexico
Malaysia
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Taiwan
Belarus
Ireland
Finland
Thailand
Vietnam
Korea, Republic of
France
Colombia

location_facility: Congenital Heart Center of the University of Florida

location_facility: Dnipropetrovsk clinical medical center of Mother and Child after prof. Rudnev

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

location_facility: CAPA Istanbul University Medical Faculty

location_facility: MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery'

location_facility: Gottsegen György Országos Kardiológiai Intézet

location_facility: Guangzhou Women And Children's Medical Center

location_facility: Drottning Silvias barn- och ungdomssjukhus

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Dr. Siyami Ersek Gogus Kalp ve Damar Cerrahisi Training and Research Hospital

location_facility: Veltischev Research and Clinical Institute for Pediatrics of the Pirogov RNRMU

location_facility: Izmir Tepecik Training and Research Hospital

location_facility: AOU Città della Salute e della Scienza di Torino, Presidio Ospedale Infantile Regina Margherita

location_facility: Pusan National University Yangsan Hospital

location_facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu

location_facility: Behcet Uz Pediatric Diseases and Surgery Training and Research Hospital

location_facility: Samara Regional Clinical Cardiological Dispensary

location_facility: MI Zaporizhzhia Regional Clinical Childrens Hospital of Zaporizhzhia Regional Council

location_facility: Childrens City Clinical Hospital n.a. Bashlyaeva

location_facility: Mehmet Akif Ersoy Training and Research Hospital

location_facility: Irmandade Santa Casa de Misericordia de Sao Paulo

location_facility: Health Institution 4Th City Children'S Clinical Hospital

location_facility: Vilnius University Hospital Santariskiu Clinics

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: University Medical Center Ho Chi Minh city

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Fundacao Universitaria de Cardiologia - Instituto de Cardiologia e Transplantes do DF

location_facility: Complexo de Prevencao,Diagnostico,Terapia e Reabilitacao Respiratoria LTDA Hospital Dia do Pulmao

location_facility: Cukurova Balcali Hospital Application and Research Center

location_facility: National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation

location_facility: Cardiovascular Pathology Research Institute of Siberian Branch of RAMS

location_facility: Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes

location_facility: Sumy Regional Childrens Clinical Hospital

location_facility: Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas

location_facility: The General Hospital of Northern Theater Command

location_facility: Cnce of Lviv Regional Council 'Lviv Regional Clinical Hospital'

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Scientific Practical Medical Center for Pediatric Cardiology and Cardio Surgery of the MOH

location_facility: New Children's Hospital of the Helsinki University Hospital (HUS)

location_facility: University of Virginia Division of Pediatric Cardiology

location_facility: Azienda Ospedaliera Policlinico S. Orsola-Malpighi

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka

location_facility: State Institution Republican Scientific And Practical Center For Pediatric Surgery

location_facility: SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo

location_facility: Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead

summary: The purpose of this study is to evaluate whether the addition of selexipag to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension (PAH) in comparison to placebo.


title: A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

summary: DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express human epidermal growth factor receptor 2 (HER2). Two combination therapy cohorts will be opened for enrollment, DF1001 + nivolumab and DF1001 + Nab paclitaxel. The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having either selected solid tumors, or solid tumors expressing high levels of HER2.

lead_sponsor: Dragonfly Therapeutics

location_country:
Denmark
United States
France
Belgium
Netherlands

location_facility: University of California Irvine Medical Center

location_facility: Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center

location_facility: University of Pennsylvania, Abramson Cancer Center

location_facility: University Hospitals Cleveland Medical Center

location_facility: Domaine Universitaire du Sart Tilman; CHU de Liege

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Montefiore Einstein Center for Cancer Care

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Stichting Beoordeling Ethiek Biomedisch Onderzoek


title: A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Mepolizumab 100 mg SC as add-on Treatment in Participants With COPD Experiencing Frequent Exacerbations and Characterized by Eosinophil Levels (Study 208657)

acronym: MATINEE

summary: This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) participants given as an add on to their optimized maintenance COPD therapy. The maximum duration of participant participation is approximately 109 weeks, consisting of 2 screening visits (up to 3 weeks), a run-in period (up to 2 weeks), and an intervention period of at least 52 weeks and up to 104 weeks. 800 participants will be randomized in a 1:1 ratio to receive mepolizumab 100 milligrams (mg) or placebo every 4 weeks for at least 13 doses (52 weeks treatment period) up to a maximum of 26 doses (104 weeks treatment period). The number of randomized participants may increase up to approximately 1400.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
United Kingdom
United States
Belgium
Poland
Australia
Argentina
Israel
Mexico
Sweden
Brazil
Canada
Hungary
China
Germany
Denmark
Ireland
New Zealand
Korea, Republic of
France
Netherlands


title: A Phase 2 Randomized, Double-blind, Placebo-controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in Subjects With Sjögren's Syndrome (SS)

acronym: SS

summary: The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920 (formerly MEDI4920) in adult participants with Sjögren's Syndrome (SS).

lead_sponsor: Viela Bio (acquired by Horizon Therapeutics)

location_country:
Poland
Taiwan
United Kingdom
Italy
Argentina
Hungary
Korea, Republic of
India
United States
France
Peru
Mexico

location_facility:
Research site
Research Site


title: Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With a Long-term Open-label Extension

lead_sponsor: Janssen Research & Development, LLC

ReferenceCitation: Liu AP, Cheuk DK. Disease-modifying treatments for primary autoimmune haemolytic anaemia. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012493. doi: 10.1002/14651858.CD012493.pub2.

location_country:
Poland
Brazil
Spain
Greece
Italy
Netherlands
United Kingdom
Ukraine
Hungary
Korea, Republic of
France
United States
China
Israel
Malaysia
Japan
Germany
Czechia

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely

location_facility: Affiliated Hospital of Nantong University

location_facility: Tianjin Medical University General Hospital

location_facility: Japanese Red Cross Nagoya Daiichi Hospital

location_facility: Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Scotland Cancer Treatment Center - Duke Cancer Network

location_facility: University General Hospital of Rio Patras

location_facility: Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'

location_facility: University of Colorado - Anschutz Medical Campus

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: Kyiv City Clinical Hospital #9, Department of infectious diseases

location_facility: Klinika Hematologii i Transplantologii, UCK

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

location_facility: Hospital of the University of Pennsylvania

location_facility: University General Hospital of Catalonia

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base

location_facility: Impar Servicos Hospitalares S/A - Hospital Brasília

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

location_facility: Casa de Saúde Santa Marcelina - Hospital Santa Marcelina

location_facility: First Affiliated Hospital, Medical School of Zhejiang University

location_facility: Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino

location_facility: Ternopil University Hospital of Ternopil Regional Council

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: University of North Carolina Hemophilia and Thrombosis Center

location_facility: Taussig Cancer Insititute - Cleveland Clinic

location_facility: Cherkassy Regional Oncology Dispensary, Department of Hematology

location_facility: Guangzhou First Municipal People's Hospital

location_facility: Hospital Das Clinicas Da Universidade Federal De Goias

location_facility: Beijing Chao-yang Hospital, Capital Medical University

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP

location_facility: East Carolina University-School of Medicine

location_facility: Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu

location_facility: West China Hospital of Sichuan University

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia

location_facility: General Hospital of Athens 'G. Gennimatas'

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

location_facility: Huashan Hospital affiliated to Fudan University

location_facility: Attikon University General Hospital of Attica

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: University General Hospital of Thessaloniki

location_facility: Japan Community Health care Organization Kyushu Hospital

location_facility: Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi

summary: The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).


title: A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program

acronym: BrainStorm

summary:
Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental.

Better knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients' outcome.

In this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.

lead_sponsor: Jules Bordet Institute

location_country: France Luxembourg Belgium

location_facility: CHU UCL Namur - Site de Sainte-Elisabeth

location_facility: Institut Universitaire du Cancer - Oncopole


title: Efficacy and Safety of Concizumab Prophylaxis in Patients With Haemophilia A or B Without Inhibitors

summary: This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B without inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group participants will get study medicine from the start of the study. In the other group participants will continue with their normal medicine and get study medicine after 6 months. The group will be decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will have to inject themselves with study medicine every day under the skin. This can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for about three years. Participants will have to come to the clinic for up to 33 times. The time between visits will be approximately 4 weeks for the first 6 to 12months depending on the group participants are in, and approximately 8 weeks for the rest of the study. At all visits, blood samples will be taken. Participants will be asked to record information into an electronic diary during the study and may also be asked to wear an activity tracker.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
South Africa
Japan
Poland
Portugal
Russian Federation
Australia
India
Israel
Turkey
Mexico
Malaysia
Sweden
Slovakia
Bosnia and Herzegovina
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Estonia
Thailand
Algeria
France
Korea, Republic of


title: A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer

summary:
The primary objective of the dose escalation (phase 1) part of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of REGN5093 for determination of the maximum tolerated dose (MTD) and/or definition of the recommended phase 2 dose (RP2D) of REGN5093 in patients with MET-altered Non-small cell lung cancer (NSCLC).

The primary objective of the dose expansion (phase 2) part of the study is to assess preliminary anti-tumor activity of REGN5093 as measured by the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

ipd_sharing_description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Korea, Republic of
United States
France

location_facility:
Regeneron Research Facility
Regeneron Study Site


title: Phase 2 Study of Talimogene Laherparepvec in Combination With Pembrolizumab in Subjects With Unresectable/Metastatic Stage IIIB-IVM1d Melanoma Who Have Progressed on Prior Anti PD-1 Based Therapy

lead_sponsor: Amgen

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

location_country:
Poland
Spain
Greece
Italy
Australia
Netherlands
Canada
United Kingdom
United States
France
Germany

location_facility: Medical Oncology Hematology Consultants Helen F Graham Cancer Center

location_facility: United States Oncology Regulatory Affairs Corporate Office

location_facility: Uniwersyteckie Centrum Kliniczne Centrum Medycyny Nieinwazyjnej

location_facility: Centre Hospitalier Universitaire de Nantes, HÃ´pital HÃ´tel Dieu

location_facility: IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Szpital Kliniczny im Heliodora Swiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Pozn

location_facility: University of Louisville James Graham Brown Cancer Center

location_facility: Centre Hospitalier Universitaire de Bordeaux - HÃ´pital Saint AndrÃ©

location_facility: Baylor Scott and White Research Institute

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Allina Health Systems dba Virginia Piper Cancer Institute

location_facility: Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

location_facility: UniversitÃ¤tsklinikum Carl Gustav Carus der Technischen UniversitÃ¤t Dresden

location_facility: University of Florida Health Cancer Center at Orlando Health

location_facility: Nederlands Kanker Instituut, Antoni van Leeuwenhoekziekenhuis

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy

summary: This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-programmed cell death protein (anti-PD-1) therapy in unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting. Subjects will be treated with talimogene laherparepvec and pembrolizumab until confirmed complete response, disappearance of all injectable lesions, documented confirmed disease progression per modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST), intolerance of study treatment, or 102 weeks from the first dose of talimogene laherparepvec and/or pembrolizumab, whichever occurs first.