title: A Phase 3, Randomized, Double-Blind Study of Trilaciclib or Placebo in Patients Receiving First- or Second-Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (PRESERVE 2)

acronym: PRESERVE 2

summary: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of trilaciclib versus placebo administered prior to gemcitabine and carboplatin in patients receiving first- or second-line treatment for locally advanced unresectable/metastatic TNBC.

ReferenceType: derived

ReferenceCitation: Goel S, Tan AR, Rugo HS, Aftimos P, Andric Z, Beelen A, Zhang J, Yi JS, Malik R, O'Shaughnessy J. Trilaciclib prior to gemcitabine plus carboplatin for metastatic triple-negative breast cancer: phase III PRESERVE 2. Future Oncol. 2022 Oct;18(33):3701-3711. doi: 10.2217/fon-2022-0773. Epub 2022 Sep 22.

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

lead_sponsor: G1 Therapeutics, Inc.

location_country:
Moldova, Republic of
Poland
Australia
United States
China
Spain
Ukraine
Bulgaria
Georgia
Russian Federation
France

location_facility: Florida Cancer Specialists - North (SCRI)

location_facility: ARENSIA Exploratory Medicine Harmony Health

location_facility: IMSP Institutul Oncologic, ARENSIA Exploratory Medicine

location_facility: Komunalne nekomertsiine pidpryiemstvo Ternopilskyi oblasnyi klinichnyi onkolohichnyi dyspanser Ternopilskoi oblasnoi rady

location_facility: Komunalne nekomertsiine pidpryiemstvo Miska klinichna likarnia No 4 Dniprovskoi miskoi rady

location_facility: LTD Multiprofile Clinic Consilium Medulla

location_facility: Komunalne nekomertsiine pidpryiemstvo Sumskoi oblasnoi rady Sumskyi oblasnyi onkolohichnyi dyspanser

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: FSBI Russian Scientific Center of Roentgenoradiology of the MoH of Russia

location_facility: Washington Cancer Institute at MedStar Washington Hospital Center - Oncology Research

location_facility: Peter MacCallum Cancer Centre - Oncology

location_facility: State Budgetary Healthcare Institution of Moscow Region "Moscow Reginoal Oncology Dispensary"

location_facility: The First Affiliated Hospital of Chongqing Medical University

location_facility: Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Oncology Dispensary"

location_facility: SAHI Republcx Clinical Oncology Dispensary of the Ministry of Healthcare of Tatarstan Republix

location_facility: The Fourth Hospital of Hebei Medical University

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Chorob Rozrostowych

location_facility: First Affiliated Hospital of Zhengzhou University

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

location_facility: Budgetary Healthcare Institution of Omsk Region "Clinical Oncological Dispensary"

location_facility: Acad.Fridon Todua Medical Center - Research Institute of Clinical Medicine

location_facility: Volynskyi oblasnyi medychnyi tsentr onkolohii

location_facility: LTD Israeli-Georgian Medical Research Clinic Helsicore


type: EudraCT Number

title: A 2-year Extension Study to Evaluate Long-term Effectiveness of Mavenclad® in Participants Who Have Completed Trial MS700568_0022 (MAGNIFY MS) (Magnify MS Extension)

summary: The primary purpose of this study is to evaluate the long-term effectiveness of Mavenclad® tablets, in terms of disease activity and safety, in participants with highly-active relapsing multiple sclerosis (RMS) previously participating in the MAGNIFY MS trial MS700568_0022 (NCT03364036).

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

lead_sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

location_country:
Finland
Germany
Italy
Poland
Hungary
Israel
United Kingdom
Australia
Sweden
Austria
Spain
Czechia
Canada
France

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 7 SUM

location_facility: Children's Hospital, London Health Sciences Centre- Pediatrics

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko SUM w Katowicach

location_facility: IRCSS Neuromed Istituto Neurologico Mediterraneo

location_facility: Università "G. D'Annunzio" Chieti-Pescara Ospedale Cliniciz

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo

location_facility: Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

location_facility: CHU de Montpellier Hôpital Gui de Chauliac- Département de Neurologie

location_facility: Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice

location_facility: Akademiskt Specialist Centrum - Centrum för Neurologi,

location_facility: Dipartimento di internistica clinica e sperimentale "Flaviano Magrassi"Università degli studi della Campania "Luigi Vanvitelli"

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


acronym: AVONELLE-X

lead_sponsor: Hoffmann-La Roche

summary:
This main long-term extension study is designed to evaluate the long-term safety and tolerability of faricimab 6 milligrams (mg) administered by intravitreal injection at a personalized treatment interval (PTI) to participants with neovascular age-related macular degeneration (nAMD) who enrolled in and completed one of the Phase III studies: GR40306 (NCT03823287) or GR40844 (NCT03823300), also referred to as the parent studies. Eligible patients who consent to participate in this main study will be enrolled upon completion of the end-of-study visit in the parent study.

Additionally, there is a substudy that is being conducted. The aim of this substudy is to evaluate the impact of intravitreal faricimab on the health of the corneal endothelial cells in the study eyes of patients with nAMD to fulfill a U.S. Food and Drug Administration (FDA) post-marketing requirement. The fellow eyes of the same enrolled participants in the substudy will serve as the controls.

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Hospital dos de maig; servicio de oftalmologia

location_facility: Specialized Hospital for Active Treatment of Eye Diseases Zora

location_facility: Queen Mary Hospital; Department of Ophthalmology

location_facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

location_facility: Tokyo Medical University Hachioji Medical Center

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

location_facility: Chang Gung Medical Foundation - Linkou; Ophthalmology

location_facility: Ankara University Medical Faculty; Department of Ophthalmology

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

location_facility: 1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Changhua Christian Hospital; Department of Ophthalmology

location_facility: Tokyo Women's Medical University Hospital

location_facility: Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia

location_facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen

location_facility: Retina Consultants of Southern California

location_facility: Ankara Baskent University Medical Faculty; Department of Ophthalmology

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

location_facility: Eszak-Pesti Centrumkorhaz - Honvedkorhaz; Szemeszet

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

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

location_facility: Gloucestershire Hospitals NHS Foundation Trust

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

location_facility: Hacettepe University Medical Faculty; Department of Ophthalmology

location_facility: California Eye Specialists Medical group Inc.

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: Augenabteilung am St. Franziskus-Hospital

location_facility: National Defense Medical College Hospital

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia

location_facility: Hopital de la croix rousse; Ophtalmologie

location_facility: Japanese Red Cross Nagasaki Genbaku Hospital

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

location_facility: University of California, Davis, Eye Center

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

location_facility: Hospital Universitario Miguel Servet; Servicio de Oftalmologia

location_facility: Kansai Medical University Medical Center

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

location_facility: Selcuk University Faculty of Medicine; Department Of Ophthalmology

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

location_facility: Taipei Veterans General Hospital; Ophthalmology

location_facility: University Retina and Macula Associates, PC

location_facility: Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

location_facility: Seoul National University Bundang Hospital

location_facility: Rigshospitalet Glostrup; Afdeling for Øjensygdomme, Center for Forskning

location_facility: The Ohio State University Havener Eye Institute

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

location_facility: Centre Paradis Monticelli; Ophtalmologie

location_facility: Gazi University Faculty of Medicine; Department Of Ophthalmology

location_facility: Northern California Retina Vitreous Associates

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

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Southeastern Retina Associates Chattanooga

location_facility: University of British Columbia - Vancouver Coastal Health Authority

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

location_facility: Specjalistyczny O?rodek Okulistyczny Oculomedica

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

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Hospital de Sao Joao; Servico de Oftalmologia

location_facility: Universitätkslinikum Düsseldorf, Augenklinik; Klinik fürAugenheilkunde

location_facility: Shiga University Of Medical Science Hospital

location_facility: Northwestern Medical Group/Northwestern University

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

location_facility: Bristol Eye Hospital;Retinal Treatment and Research Unit

location_facility: Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia

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

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Ege University Medical Faculty; Department of Ophthalmology

title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (AVONELLE-X)

primary_purpose: Treatment

source: euctr

ipd_sharing_description:
For eligible studies, 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 the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing).

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


title: A Phase II, Open-label, Single-arm Study of Berzosertib (M6620) in Combination With Topotecan in Participants With Relapsed Platinum-resistant Small-Cell Lung Cancer (DDRiver SCLC 250)

summary: The main purpose of this study is to assess efficacy, safety, tolerability and pharmacokinetics (PK) of Berzosertib in combination with Topotecan in participants with relapsed, platinum-resistant small-cell lung cancer (SCLC). This study will be conducted in two parts: safety run-in part and main part. The safety run-in part will be conducted in Japan.

status: Completed

study_completion_date_type: Actual

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Italy
Japan
Belgium
United States
China
Spain
France

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

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Hospital Clinico Universitario Virgen de la Victoria - Oncology Service

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hopital Albert Calmette - CHU Lille - service de pneumologie et immuno allergologie

location_facility: Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

location_facility: Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie

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

location_facility: Cancer & Hematology Centers of Western Michigan

location_facility: IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST

location_facility: The First Affiliated Hospital of Zhejiang University school of medicine

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

location_facility: Cotton-O'Neil Clinical Research Center, Hematology and Oncology

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil - Service de Pneumologie

location_facility: CHU Nantes - Hôpital Guillaume et René Laënnec - Service de Pneumologie

location_facility: CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale

location_facility: Institut Jules Bordet - Department of Institut Jules Bordet

status_simplified: Completed


title: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants Who Have Thrombotic Microangiopathy Associated With a Trigger

summary: This study will investigate the efficacy and safety of ravulizumab compared to placebo in adult participants with thrombotic microangiopathy (TMA) associated with a trigger. Participants will be randomized to receive either ravulizumab plus best supportive care or placebo plus best supportive care. The treatment period is 26 weeks followed by a 26-week off-treatment follow-up period.

status: Terminated

design_allocation: Randomized

ipd_sharing: No

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
Italy
United Kingdom
Japan
Netherlands
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
France

intervention_type: Other

status_simplified: Unknown


acronym: SUNLIGHT

lead_sponsor: Taiho Oncology, Inc.

summary: This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.

ReferenceType: result

ReferenceCitation: Prager GW, Taieb J, Fakih M, Ciardiello F, Van Cutsem E, Elez E, Cruz FM, Wyrwicz L, Stroyakovskiy D, Papai Z, Poureau PG, Liposits G, Cremolini C, Bondarenko I, Modest DP, Benhadji KA, Amellal N, Leger C, Vidot L, Tabernero J; SUNLIGHT Investigators. Trifluridine-Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer. N Engl J Med. 2023 May 4;388(18):1657-1667. doi: 10.1056/NEJMoa2214963.

oa_host_type: closed

publisher_dissemination: Massachusetts Medical Society

sponsor_collaborators: Institut de Recherches Internationales Servier

location_facility: "Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica"

location_facility: Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly

location_facility: "INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica"

location_facility: Hospital Sao Camilo Nucleo de Pesquisa Av Alcantara Machado

location_facility: Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.

location_facility: LLC Ukrainian Center of Tomotherapy "Tomoclinic", Chemoteraphy Department

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy Klinika Onkologii i Radioterapii

location_facility: Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly

location_facility: Oncology dispensary No.2 Oncology department

location_facility: Markusovszky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly

location_facility: Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei

location_facility: Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy

location_facility: "HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica"

location_facility: "Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)"

location_facility: "Hospital de Base Centro Integrado de Pesquisa"

location_facility: Podillia Regional Oncology Centre Chemotherapy Department

location_facility: Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica Strada Statale 554 Sestu-Monserrato

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii

location_facility: Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III

location_facility: Scientific Centre for Specialized Medical Care (oncological) Chemotherapy

location_facility: "Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie"

location_facility: Hospital A C Camargo Unidade de Pesquisa Clinica Rua Antonio Prudente

location_facility: "Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V"

location_facility: "CHU Jean Minjoz Service d'oncologie médicale"

location_facility: Hospital Universitario Miguel Servet Edif. de maternidad planta 8. Servicio de Oncología Médical

location_facility: A.O.U. Seconda Universita degli Studi di Napoli U.O.C di Oncologia Medica e di Ematologia Dipartimento Medico di Internistica clinca e sperimentale " F Magrassi - A. Lanzara" Via Sergio Pansisni ,

location_facility: "Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling"

location_facility: Ospedale San Carlo U.O. Oncologia Medica Via Potito Petrone, Ctr Macchia Romana

location_facility: "Clinical and diagnostic Centre of Medics-rey Inter. Group LLC Hospital of Israeli Oncology "LISOD"

location_facility: Hospital Albert Einstein Instituto de Ensino e Pesquisa Av Albert Einstein

location_facility: University Headache Clinic Outpatient oncology clinic

location_facility: "Odense Universitetshospital Department of Oncology"

location_facility: Centralny Szpital Kliniczny MSWiA Oddział Radioterapii i Onkologii

location_facility: Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont

location_facility: IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia Vale Cappuccini 1

location_facility: A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2

location_facility: "Universitair Ziekenhuis Antwerpen Oncologie"

location_facility: Clinical Oncology Dispensary No.1 Chemotherapy Department

location_facility: "H. Valle de Hebrón Servicio de Oncología - (VHIR)"

location_facility: "CHU Morvan Institut de Cancérologie et d'Hématologie"

location_facility: "MI ""Dnipropetrovsk City Multi-field Clinical Hospital #4"" Department of Oncology"

location_facility: Arkhangelsk Clinical Oncology Dispensary chemotherapy department

location_facility: CHU de Poitiers Pole Régional de Cancérologie

location_facility: H.VIRGEN DEL ROCIO Servicio de Oncología Médica

location_facility: Szent Imre Egyetemi Oktatokorhaz Klinikai Onkologiai Osztaly

location_facility: "ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa"

location_facility: "UZ Leuven Campus Gasthuisberg Digestieve Oncologie"

location_facility: SBIH of YR "Clinical oncology hospital chemotherapy department"

location_facility: "Ordensklinikum Linz Barmherzige Schwestern Interne I"

location_facility: JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum

location_facility: Wojskowy Instytut Medyczny Klinika Onkologii

location_facility: "Hospital Universitario Marqués de Valdecilla oncología medica"

location_facility: DuPage Medical Group - Joliet Oncology-Hematology Associates

location_facility: "Hospital Universitario Ramón y Cajal Servicio de Oncologia Médica"

location_facility: National Medical Research Center of Oncology N.N. Petrova

location_facility: Arcispedale Santa Maria Nuova Unità di Oncologia

location_facility: National Institute of Cancer Abdominal Oncology Department

location_facility: Pan American Center for Oncology Trials, LLC

location_facility: H. GENERAL DE VALENCIA Servicio de Oncología Médica

location_facility: "Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive"

location_facility: Istituto Clinico Humanita IRCCS Dipartimento di Oncologia Medica ed Ematologia Via Manzoni,

location_facility: Hôpital Saint-Antoine Service d'Oncologie Médicale

location_facility: "Hospital de la Santa Creu I Sant Pau Oncología Medica"

location_facility: Charite Universitätsmedizin Medizinische Klinik m.S. Haemat., Onko., Tumorimmunologie

location_facility: Istituto Nazionale Tumori, I.R.C.C.S "Fondazione G Pascale" Struttura Complessa di Oncologia Medica Addominale

location_facility: Medical Center n.a. Acad. Spizhenko "Syber Clinic Spizhenko"" Department of Oncology

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika

location_facility: Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej

location_facility: "Centre de lutte contre le cancer Francois Baclesse UCP Digestif"

location_facility: Moscow City Oncology Hospital # 62 chemotherapy department

location_facility: "Aalborg Universitetshospital, Syd Onkologisk Afdeling"

location_facility: Istituto Oncologico Veneto IOV - IRCCS Unita Operativa Complessa Oncologia Medica 1 Via Gattamelata 64

location_facility: Omsk Clinical Oncologic Dispensary Chemotherapy

location_facility: Investigative Clinical Research of Indiana LLC

location_facility: "Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica"

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists

title: An Open-label, Randomized, Phase III Study Comparing Trifluridine/Tipiracil in Combination With Bevacizumab to Trifluridine/Tipiracil Monotherapy in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT Study)

location_country:
Germany
Italy
Poland
Hungary
Denmark
Brazil
Austria
Belgium
United States
Spain
Ukraine
Puerto Rico
Russian Federation
France

collaborators: Institut de Recherches Internationales Servier


acronym: SPRINTER

lead_sponsor: Synairgen Research Ltd.

summary: The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery of hospitalised patients receiving oxygen with confirmed Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). Safety and other efficacy endpoints will also be assessed.

location_facility: Fundación Santos y de la Garza Evia, I.B.P

location_facility: Clínica Sociedad Española de Beneficencia

location_facility: Oriion Citicare Super Speciality Hospital - Intern

location_facility: Sociedade Literaria e Caritativa Santo Agostinho

location_facility: Post Graduate Institute of Medical Education & Research, Chandigarh

location_facility: Bangalore Medical College and Research Institute

location_facility: Newcastle University - Institute of Cellular Medicine (ICM)

location_facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

title: A Randomised, Double-blind, Placebo-controlled, Phase III Trial to Determine the Efficacy and Safety of Inhaled SNG001 for the Treatment of Patients Hospitalised Due to Moderate COVID-19

location_country:
Germany
Italy
Colombia
India
Portugal
Israel
Argentina
Romania
United Kingdom
Brazil
Netherlands
Mexico
Belgium
United States
Spain
Serbia
France

ipd_sharing: Undecided


title: A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of GSK3511294 Adjunctive Therapy in Adult and Adolescent Participants With Severe Uncontrolled Asthma With an Eosinophilic Phenotype

summary: This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study that aims to assess the efficacy and safety of GSK3511294 (Depemokimab) in participants with severe uncontrolled asthma with an eosinophilic phenotype

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

lead_sponsor: GlaxoSmithKline

sponsor_collaborators:
GlaxoSmithKline
Iqvia Pty Ltd

location_country:
Germany
Ireland
Italy
Poland
United Kingdom
United States
China
Spain
Czechia
Canada
Russian Federation
France


summary: This study will assess the efficacy and safety of GSK3511294 (Depemokimab) as an adjunctive therapy in participants with severe uncontrolled asthma with an eosinophilic phenotype.

location_country:
Italy
Poland
Hungary
Australia
Japan
United States
Spain
Taiwan
Czechia
Canada
France

intervention_type: Biological


lead_sponsor: Bayer

summary:
Researchers are looking for a better way to treat people with solid tumors. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.

In this trial, the researchers want to learn about regorafenib taken together with nivolumab in a small number of participants with different types of tumors. These include tumors in the head and neck, the esophagus, the pancreas, the brain, and the biliary tract. The biliary tract includes gall bladder and bile ducts.

The trial will include about 200 participants who are at least 18 years old. All of the participants will take 90 mg of regorafenib as a tablet by mouth. The dose of regorafenib can be adjusted up to 120 mg or down to 60 mg by the doctor based on how well a participant tolerates treatment. All of the participants will receive 480 milligrams (mg) of nivolumab through a needle put into a vein (IV infusion).

The participants will take treatments in 4-week periods called cycles. They will take regorafenib once a day for 3 weeks, then stop for 1 week. In each cycle, the participants will receive nivolumab one time. These 4-week cycles will be repeated throughout the trial. The participants can take nivolumab and regorafenib until their cancer gets worse, until they have medical problems, or until they leave the trial. The longest nivolumab can be given is up to 2 years.

During the trial, the doctors will take pictures of the participants' tumors using CT or MRI and will take blood and urine samples. The doctors will also do physical examinations and check the participants' heart health using an electrocardiogram (ECG). They will ask questions about how the participants are feeling and if they have any medical problems.

sponsor_collaborators: Bristol Myers Squibb Co. and Ono Pharmaceutical Co., Ltd

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Institut Claudius Regaud - iUCT Oncopole

location_facility: Institut Gustave Roussy - Département de Médecine Oncologique

location_facility: Baylor Charles A. Sammons Cancer Center at Dallas

location_facility: ASST Grande Ospedale Metropolitano Niguarda

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

location_facility: Institut de Cancérologie de l'Ouest - Saint Herblain

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Rocky Mountain Cancer Centers / Aurora, CO

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

location_facility: University Hospitals Coventry and Warwickshire NHS Trust

location_facility: H. Lee Moffitt Cancer Center & Research Institute

title: A Multi-indication, Single-treatment Arm, Open-label Phase 2 Study of Regorafenib and Nivolumab in Combination in Patients With Recurrent or Metastatic Solid Tumors

ipd_sharing_description: Availability of this study's data will 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 Study sponsors section of the portal.

location_country:
Italy
United Kingdom
Japan
Belgium
United States
Korea, Republic of
Taiwan
France


title: GRECO-2: A Randomized, Phase 2b Study of GC4711 in Combination With Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Unresectable or Borderline Resectable Nonmetastatic Pancreatic Cancer

summary: GTI-4711-201 is designed as a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the effect to OS by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic

ReferenceCitation: Squillace S, Salvemini D. Nitroxidative stress in pain and opioid-induced adverse effects: therapeutic opportunities. Pain. 2022 Feb 1;163(2):205-213. doi: 10.1097/j.pain.0000000000002347. No abstract available.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Galera Therapeutics, Inc.

location_country:
United States
United Kingdom
Canada
France

location_facility: Imperial College London, Saint Mary's Hospital

location_facility: Institut régional du Cancer de Montpellier

location_facility: Radiation Oncology and Gamma Knife Center of Oregon

location_facility: University of Iowa Hospitals and Clinics

location_facility: Atlantic Clinical Cancer Research Unit/QEII Health Sciences Centre

location_facility: University of Washington Medical Center (UWMC) - Radiation Oncology Center


title: PSMAfore: A Phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in the Treatment of Taxane Naïve Men With Progressive Metastatic Castrate Resistant Prostate Cancer

acronym: PSMAfore

summary:
The purpose of this study is to determine whether 177Lu-PSMA-617 improves the rPFS or death compared to a change in ARDT in mCRPC participants that were previously treated with an alternate ARDT and not exposed to a taxane-containing regimen in the CRPC or mHSPC settings.

Approximately 450 participants will be randomized (225 per treatment group).

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Poland
Slovakia
United Kingdom
Sweden
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Czechia
Canada
France

location_facility: NYU Laura and Isaac Perlmutter Cancer Center NYU Langone Medical Center

location_facility: Tulane University Health Sciences Center .

location_facility: Mount Sinai Hospital School of Medicine Tisch Cancer Institute

location_facility: Duke University Medical Center Morris Building

location_facility: The Ohio State University Comprehensive Cancer Center PulmonaryClinicalTrialsOffice

location_facility: Rocky Mountain Cancer Centers RMCC - Aurora

location_facility: Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering CC

location_facility: Virginia Oncology Associates VOA - Lake Wright

location_facility: Beth Israel Deaconess Medical Center Dept. of BIDMC

location_facility: Washington University School Siteman Cancer Center

location_facility: Oncology Hematology Associates of Southeast Virginia Roanoke Loc

location_facility: Dana Farber Cancer Institute Dana-Farber Cancer Institute_

location_facility: Nebraska Cancer Specialists Oncology Hematology West


lead_sponsor: Allergan

summary: This study will evaluate the Long-Term Safety and Tolerability of Atogepant 60 mg daily for the Prevention of Migraine in Participants with Chronic or Episodic Migraine

location_facility: Alpine Clinical Research Center /ID# 226203

location_facility: AP-HP - Hopital Lariboisière /ID# 226220

location_facility: Centrum Medyczne Pratia Gdynia /ID# 226431

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 226409

location_facility: Mount Vernon Clinical Research /ID# 226249

location_facility: Abington Neurological Associates - Abington /ID# 226449

location_facility: FutureSearch Trials of Neurology /ID# 226424

location_facility: Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 226389

location_facility: MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 226417

location_facility: Taipei Veterans General Hospital /ID# 226206

location_facility: Yonsei University Health System Severance Hospital /ID# 226265

location_facility: Hospital Universitario Virgen del Rocio /ID# 226333

location_facility: Seoul National University Hospital /ID# 226199

location_facility: Nowon Eulji Medical Center, Eulji University /ID# 226261

location_facility: Ospedale Ss. Filippo e Nicola /ID# 228627

location_facility: ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226456

location_facility: Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 228630

location_facility: Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 229991

location_facility: J. Lewis Research, Inc. / Foothill Family Clinic /ID# 226248

location_facility: Preferred Primary Care Physicians, Inc. /ID# 226447

location_facility: Hospital Universitario Vall d'Hebron /ID# 226338

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 228625

location_facility: CHU Nice - Hopital de Cimiez /ID# 228419

location_facility: Allied Physicians - Fort Wayne Neurological Center /ID# 226390

location_facility: Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226412

location_facility: Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231571

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 226335

location_facility: Vancouver Island Health Authority /ID# 226255

location_facility: CTI Clinical Research Center /ID# 226278

location_facility: J. Lewis Research, Inc. Foothill Family Clinic South /ID# 226328

location_facility: Ottawa Headache Centre Research Inc /ID# 226451

location_facility: Albany Medical Center Rheumatology /ID# 228212

location_facility: Accel Research Sites - Tampa Clinical Research Unit /ID# 226252

location_facility: King's College Hospital NHS Foundation Trust /ID# 226524

location_facility: Tri-Service General Hospital /ID# 228998

location_facility: Pusan National University Hospital /ID# 231416

location_facility: Dongtan Sacred Heart Hospital /ID# 226264

location_facility: Aggarwal and Associates Limited /ID# 226452

location_facility: Specjalistyczne Gabinety Sp. z o.o. /ID# 228631

location_facility: Stetson-University of Cincinnati /ID# 226326

location_facility: Northwest Clinical Research Center /ID# 226240

location_facility: Josephson-Wallack-Munshower Neurology - NE /ID# 226295

location_facility: Barrow Neurological Institute /ID# 228217

location_facility: Diex Recherche Sherbrooke Inc. /ID# 226427

location_facility: Fakultni Thomayerova nemocnice /ID# 228409

location_facility: Hospital Clinico Universitario de Valladolid /ID# 226330

location_facility: Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226433

location_facility: Canisius-Wilhelmina Ziekenhuis /ID# 226410

location_facility: Klinische Forschung Hannover-Mitte GmbH /ID# 226305

location_facility: Headache Neurology Research Institute /ID# 226234

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 228418

location_facility: CHU Clermont Ferand - Hopital Gabriel Montpied /ID# 226459

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 228624

location_facility: California Headache and Balance Center /ID# 226241

location_facility: Albuquerque Clinical Trials, Inc /ID# 226523

location_facility: Schuster Medical Research Institute /ID# 226246

location_facility: Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226404

location_facility: Sentara Family Medicine Physicians /ID# 226448

location_facility: Austin Clinical Trial Partners /ID# 228391

location_facility: Re:Cognition Health - London /ID# 231205

location_facility: Beth Israel Deaconess Medical Center /ID# 228214

location_facility: Centrum Leczenia Padaczki i Migreny /ID# 226458

location_facility: Clinical Research Institute, Inc /ID# 226232

location_facility: AP-HM - Hopital de la Timone /ID# 226407

title: A Phase 3, Multicenter, Open-Label 156-Week Extension Study To Evaluate The Long-Term Safety And Tolerability Of Oral Atogepant For The Prevention Of Migraine In Participants With Chronic Or Episodic Migraine

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
Netherlands
United States
Korea, Republic of
Spain
Taiwan
Czechia
Canada
France


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined With KRT-232 in Patients With Relapsed/Refractory (R/R) FLT3+ Acute Myeloid Leukemia (AML)

summary: This study evaluates TL-895, a potent, orally available and highly selective irreversible tyrosine kinase inhibitor combined with navtemadlin (KRT-232), a novel oral small molecule inhibitor of MDM2 for the treatment of adults with FLT3 mutated Acute Myeloid Leukemia. Participants must be relapsed/refractory (e.g., having failed prior therapy) to be eligible for this study.

design_allocation: Non-Randomized

lead_sponsor: Telios Pharma, Inc.

sponsor_collaborators:
Telios Pharma, Inc.
Kartos Therapeutics, Inc.

location_country:
Germany
Italy
Australia
Austria
United States
Korea, Republic of
Spain
France

location_facility: University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology

location_facility: University of California, Irvine Medical Center

location_facility: Polyclinic S. Orsola-Malpighi, Operative Unit of Hematology

location_facility: Romagnolo Scientific Institute of Meldola (IRST) S.r.l., Department of Oncology and Clinical and Experimental Haematology

location_facility: Medical University Vienna, Department of Internal Medicine I, Clinical Department of Hematology and Hemostaseology

location_facility: Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization

location_facility: University Hospital Germans Trias i Pujol, Department of Clinical Hematology

location_facility: Seoul National University Hospital, Department of Hemato-Oncology

location_facility: Hannover Medical School, Center for Internal Medicine, Clinic of Hematology, Hemostaseology, Oncology and Stem Cell Transplantation

location_facility: University of Sunshine Coast-Sippy Downs

location_facility: University Hospital Jena, Clinic of Internal Medicine II, Department of Hematology and Medical Oncology

location_facility: University Duisburg-Essen, University Hospital Essen, Department of Internal Medicine

location_facility: Hospital Universitario y Politécnico de La Fe

location_facility: UT Southwestern Medical Center, Harold C. Simmons Cancer Center

location_facility: Rush University Medical Center, Division of Hematology Oncology and Cell Therapy

location_facility: University Hospital - Ospedali Riuniti Umberto I - GM Lancisi - G Salesi of Ancona, Haematology Clinic

location_facility: University Hospital Hamburg-Eppendorf, Department of Internal Medicine II

location_facility: University Clinical Hospital of Valencia, Department of Hematology and Medical Oncology


title: A Phase II, Randomized, Double Blind Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Patients With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck

summary: The primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) on the basis of confirmed objective response rate. In addition, safety, pharmacokinetics, immunogenicity of atezolizumab and tiragolumab will be evaluated.

enrollment_type: Anticipated

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:
Italy
Poland
New Zealand
Hungary
United Kingdom
United States
Korea, Republic of
Spain
Thailand
Greece
Taiwan
Czechia
France

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Periph. University General Hospital of Heraklion Crete; Oncology Department

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Taipei Veterans General Hospital; Department of Oncology

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

location_facility: Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Attiko Hospital University of Athens; 2Nd Dept. of Propaedeutic Medicine

location_facility: Gy?r-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzia? Onkologii Klinicznej i Doswiadczalnej

location_facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

location_facility: Beskidzkie Centrum Onkologii- Szpital Miejski

location_facility: Washington University School of Medicine

location_facility: CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. ?W. JANA Z DUKLI; II Oddzia? Onkologii Klinicznej

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo

location_facility: National Taiwan University Hospital; Oncology

location_facility: Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Hospital Universitari i Politecnic La Fe; Oncologia

location_facility: Moores Cancer Center at UC San Diego Health

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Songklanagarind Hospital; Department of Oncology

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

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet


acronym: EPCORE™ NHL-2

lead_sponsor: Genmab

summary: A phase 1b/2, open-label, multinational, interventional trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab (EPKINLY™) in combination with other standard of care (SOC) agents in participants with B-cell Non-Hodgkin Lymphoma (B-NHL).

sponsor_collaborators: Genmab AbbVie

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: John Theurer Cancer Center at Hackensack UMC

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: Oslo Universitetssykehus HF, Radiumhospitalet

location_facility: Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Universitair Medisch Centrum Groningen (UMCG)

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

location_facility: Fondazione del Piemonte per l Oncologia Istituto di Candiolo IRCCS

location_facility: UMPC Hillman Cancer Center Cancer Pavillion

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

location_facility: University of Michigan Comprehensive Cancer Center

status: Recruiting

title: A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

type: Registry Identifier

type: Other Identifier

location_country:
Finland
Italy
Norway
United Kingdom
Denmark
Australia
Sweden
Netherlands
Belgium
United States
Spain
Czechia
France


title: A Phase 1b/2, Open-Label, Randomized Platform Study Evaluating The Efficacy and Safety of AB928 Based Treatment Combinations in Patients With Metastatic Colorectal Cancer

summary: This randomized phase 1b/2 open-label study will evaluate the antitumour activity and safety of etrumadenant (AB928) treatment combinations in participants with metastatic colorectal cancer.

ipd_sharing_description:
Arcus 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.

For more information, please visit our website.

lead_sponsor: Arcus Biosciences, Inc.

sponsor_collaborators:
Arcus Biosciences, Inc.
Gilead Sciences

location_country:
Italy
United Kingdom
United States
Korea, Republic of
Spain
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Winship Cancer Institute at Emory University

location_facility: Seoul National University Hospital (SNUH)

location_facility: Washington University School of Medicine

location_facility: Universita di Siena - Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte

location_facility: Seoul National University Bundang Hospital

location_facility: Groupe Hospitalier Pitie-Salpetriere-Centre De Recherche et de Medecine de l'Obesite

location_facility: NYU Langone Medical Center - NYU Medical Oncology Associates

location_facility: University of Wisconsin School of Medicine

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Asan Medical Center, University of Ulsan College of Medicine

location_facility: Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: The University of Texas MD Anderson Cancer Center

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

location_facility: IRCCS - Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

location_facility: U.O Farmeaceutica Ospealiera e Politche del Farmaco

location_facility: American Oncology Partners of Maryland,PA

location_facility: City of Hope Comprehensive Cancer Center


title: MAGNETISMM-3 AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY

summary: The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can provide clinical benefit in participants with relapsed/refractory multiple myeloma. Elranatamab is a bispecific antibody: binding of Elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

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:
Germany
Poland
United Kingdom
Australia
Japan
Belgium
United States
Spain
Canada
France

location_facility: Universitätsklinikum Hamburg - Eppendorf

location_facility: Indiana Blood and Marrow Transplantation-Clinic

location_facility: Blood and Marrow Transplant Group of Georgia

location_facility: McGill University Health Centre - Glen Site

location_facility: Winship Cancer Institute @ Emory University Hospital Midtown

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: CIUSSS-EMTL, Installation Hopital Maisonneuve-Rosemont

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

location_facility: University of Iowa Hospitals and Clinics

location_facility: Norton Cancer Institute, St. Matthews Campus

location_facility: Weill Cornell Medical College - New York-Presbyterian Hospital

location_facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy

location_facility: Weill Cornell Medical College - New York Presbyterian Hospital

location_facility: Winship Cancer Institute, Emory University

location_facility: Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Loyola University Chicago performing research at Loyola University Medical Center

location_facility: Uniwersytecki Szpital Kliniczny im.Jana Mikulicza -Radeckiego we Wroclawiu

location_facility: CHU de Poitiers, Pôle Régional de Cancérologie

location_facility: Indiana Blood and Marrow Transplantation-Administrative Offices

location_facility: UC Irvine Health - Chao Family Comprehensive Cancer Center

location_facility: Institut Catala d' Oncologia. Hospital Universitari Germans Trias i Pujol

location_facility: Kobe City Medical Center General Hospital


title: A Phase 3, Open-Label, Randomized Study Evaluating Metastatic Castrate Resistant Prostate Cancer Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH)

acronym: SPLASH

summary: The purpose of this study is to evaluate the efficacy and safety of [Lu-177]-PNT2002 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with androgen receptor axis-targeted therapy (ARAT).

ReferenceType: background

ReferenceCitation: Baum RP, Kulkarni HR, Schuchardt C, Singh A, Wirtz M, Wiessalla S, Schottelius M, Mueller D, Klette I, Wester HJ. 177Lu-Labeled Prostate-Specific Membrane Antigen Radioligand Therapy of Metastatic Castration-Resistant Prostate Cancer: Safety and Efficacy. J Nucl Med. 2016 Jul;57(7):1006-13. doi: 10.2967/jnumed.115.168443. Epub 2016 Jan 21.

lead_sponsor: POINT Biopharma

location_country:
France
United Kingdom
Netherlands
United States
Canada
Sweden

location_facility: Arizona Institute of Urology (AIU) - Tucson

location_facility: London Health Sciences Center - Victoria Hospital

location_facility: New York Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Charing Cross Hospital, Department of Medical Oncology

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Dallas VA Medical Center, Nuclear Medicine Service

location_facility: Radboud University Medical Center (Radboudumc)

location_facility: Center Jean Perrin, Department of Medical Oncology

location_facility: UC Irvine Chao Family Comprehensive Cancer Center

location_facility: Excel Diagnostics & Nuclear Oncology Center

location_facility: La Timone Hospital, Nuclear Medicine Department

location_facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

location_facility: Chesapeake Urology Associates (CUA) P.A.

location_facility: Montpellier Cancer Institute, Department of Nuclear Medicine

location_facility: Erasmus University Medical Center Rotterdam

location_facility: Sunnybrook Research Institute, Odette Cancer Center

location_facility: Washington University School of Medicine

location_facility: Royal Marsden NHS Foundation Trust - Institute of Cancer Research

location_facility: University of California Los Angeles, Nuclear Medicine Clinic

location_facility: New Mexico Oncology Hematology Consultants Ltd., New Mexico Cancer Center

location_facility: Norrlands University Hospital, Department of Radiation Sciences, Oncology

location_facility: Tenon Hospital, Department of Medical Oncology

location_facility: VA Greater Los Angeles Healthcare System

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: University of Kentucky Chandler Medical Center


title: A Phase 2, Multicenter, Randomized Study of Trastuzumab Deruxtecan in Subjects With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) (DESTINY-LUNG02)

summary: This study was designed to evaluate the safety and efficacy of trastuzumab deruxtecan in HER2-mutated metastatic non-small cell lung cancer (NSCLC) participants who had disease recurrence or progression during/after at least one regimen of prior anticancer therapy (second line or later) that must have contained a platinum-based chemotherapy drug.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

sponsor_collaborators:
Daiichi Sankyo, Inc.
AstraZeneca

location_country:
Italy
Australia
Japan
Netherlands
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Henry Ford Cancer Institute/Henry Ford Hospital

location_facility: University of Colorado Denver - Anschutz Medical Campus

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Assistance Publique Hopitaux de Marseille AP-HM, Hopital NORD

location_facility: National Cheng Kung University Hospital NCKUH

location_facility: Hospital Universitari i PolitÃ¨cnic La Fe

location_facility: Seoul National University Bundang Hospital

location_facility: Chang Gung Memorial Hospital CGMH - LinKou Branch

location_facility: Humanitas Cancer Center Istituto Clinico Humanitas

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale di Napoli Strutturadi Oncologia


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 in Combination With TL-895 for the Treatment of Relapsed or Refractory Myelofibrosis and KRT-232 for the Treatment of JAK Inhibitor Intolerant Myelofibrosis.

summary: This study evaluates KRT-232 in Combination With TL-895 for the Treatment of Relapsed or Refractory Myelofibrosis and KRT-232 for the Treatment of JAK Inhibitor Intolerant Myelofibrosis.

lead_sponsor: Kartos Therapeutics, Inc.

sponsor_collaborators:
Kartos Therapeutics, Inc.
Telios Pharma, Inc.

location_country:
Germany
Italy
Poland
Hungary
Austria
United States
Spain
Bulgaria
Serbia
France

location_facility: University Multiprofile Hospital for Active Treatment Dr. Georgi Plovdiv

location_facility: University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology

location_facility: Hematology Clinic Specialized Hospital for Active Treatment of Hematological Diseases, Sofia

location_facility: Slupsk Provincial Specialist Hospital n.a. Janusz Korczak, Department of Hematology

location_facility: University of Alabama at Birmingham School of Medicine, Division of Hematology and Oncology

location_facility: Jan Biziel University Hospital #2 in Bydgoszcz, Department of Hematology

location_facility: Moritz Kaposi General Hospital, Department of Hematology

location_facility: Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka

location_facility: Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine III, Hematology

location_facility: CHU de Limoges Service Hématologie Clinique et Thérapie Cellulaire

location_facility: Hospital Casa Sollievo della Sofferenza, Department of Oncology and Hematology, Division of Hematology

location_facility: University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski, Pleven

location_facility: Meduni Wien, Univ. Klinik für Innere Medizin I

location_facility: Frederic Chopin Provincial Teaching Hospital No. 1 in Rzeszow, Department of Hematology

location_facility: Hospital of Ravenna, Operative Unit of Hematology

location_facility: Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Hematology

location_facility: Memorial Sloan Kettering Cancer Center (MSKCC)

location_facility: Medical Center of the University of Pecs, 1st Department of Internal Medicine, Division of Hematology

location_facility: University Clinical Hospital of Salamanca, Department of Hematology

location_facility: University Hospital Marburg, Department of Hematology, Oncology and Immunology


acronym: STARS

lead_sponsor: VectivBio AG

summary: The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: University Polyclinic Foundation "Agostino Gemelli" - IRCCS

location_facility: M. Pirogow Provincial Specialized Hospital

location_facility: National University Corportation Tohoku University Tohoku University Hospital

location_facility: University Hospital Kralovske Vinohrady, 2nd Internal Clinic

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: St. Imre University Teaching Hospital Budapest

location_facility: Rigshospitalet - University Hospital Copenhagen

location_facility: Vanderbilt University Medical Center, Center for Human Nutrition

location_facility: Hospital of the University of Pennsylvania

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

location_facility: University General Hospital Gregorio Maranon

location_facility: Citta della salute e della Scienza di Torino Hospital

location_facility: Medical Centre, Hungarian Defence Forces

location_facility: Stadmedica, Non-Public Healthcare Facility

location_facility: Universitair Ziekenhuis Leuven - Gasthuisberg

title: A Multicenter, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Apraglutide in Adult Subjects With Short Bowel Syndrome and Intestinal Failure (SBS-IF)

location_country:
Germany
Italy
Poland
Hungary
Argentina
Denmark
Israel
Japan
Norway
Sweden
Belgium
United Kingdom
United States
Korea, Republic of
Spain
Taiwan
Czechia
France


title: A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome

acronym: EPCORE™ CLL-1

summary:
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will either be studied as:

Monotherapy, or

Combination therapy:

epcoritamab + venetoclax
epcoritamab + lenalidomide
epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine and prednisone).

The study includes patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (SLL) and patients with Richter's Syndrome (RS).

Study participants with R/R CLL/SLL are treated either with epcoritamab as monotherapy or epcoritamab + venetoclax. Study participants with RS are treated either with epcoritamab as monotherapy or epcoritamab + lenalidomide or epcoritamab + R-CHOP. The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Patients with RS are only included in the expansion phase.

location_country:
Germany
Italy
Israel
United Kingdom
Denmark
Australia
Netherlands
Belgium
United States
Spain
Czechia
France

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: The University of Texas Southwestern Medical Centre

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: CHU de Nancy - Hôpital de Brabois Adultes

location_facility: University of Michigan Comprehensive Cancer Center


lead_sponsor: Basilea Pharmaceutica

summary: The purpose of this study is to evaluate the efficacy of derazantinib monotherapy or derazantinib in combination with paclitaxel, ramucirumab, or atezolizumab in patients with HER2-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring FGFR2 genetic aberrations (GA).

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: Liga Norte-Rio-Grandense Contra o Câncer

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Fundación Favaloro para la Docencia e Investigación Médica

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

location_facility: SAIH "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of Republic Tatarstan

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Baskent University Adana Application and Research Center

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: FSBI "Clinical Research and Practical Center for specialized medical care (oncology)"

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

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

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

location_facility: Istanbul Medeniyet Uni Goztepe Training&Res Hosp

location_facility: SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva

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

location_facility: Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

title: A Phase 1b/2 Study of Derazantinib as Monotherapy and Combination Therapy With Paclitaxel, Ramucirumab or Atezolizumab in Patients With HER2-negative Gastric Adenocarcinoma Expressing FGFR2 Genetic Aberrations

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Australia
Brazil
Belgium
United States
Korea, Republic of
Spain
Turkey
Chile
Russian Federation
France


acronym: GLIMMER

lead_sponsor: Kodiak Sciences Inc

summary: This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.

location_facility: Dr Nowosielska Okulistyka i Chirurgia Oka

location_facility: Retina Consultants of Houston - (Woodlands)

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Cleveland Clinic Foundation, Cole Eye Institute

location_facility: Hôpital Lariboisière - Service Pharmacie , Essais cliniques - Aude Jacob

location_facility: Bajcsy-Zsilinszky Korhaz es Rendelointezet

location_facility: Emanuelli Research & Development Center LLC

location_facility: Specjalistyczny Szpital im. Alfreda Sokolowskiego

location_facility: AOU dell'Università degli Studi della Campania Luigi Vanvitelli

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz , Josa Andras Oktatókórház

location_facility: Northern California Retina Vitreous Associates

title: A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME)

location_country:
France
Italy
Poland
Hungary
United States
Czechia
Puerto Rico
Israel


lead_sponsor: Hoffmann-La Roche

summary: TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first.

location_facility: CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Prince of Wales Hospital; Department of Clinical Onocology

location_facility: Western Regional Medical Center at Cancer Treatment Centers of America

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III

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

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

location_facility: Ospedale Regionale di Bellinzona Medizin Onkologie

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

location_facility: Institut de Cancerologie Gustave-Roussy (IGR)

location_facility: Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: Clinica Universidad de Navarra Madrid; Servicio de Oncología

location_facility: University of New Mexico; Comprehensive Cancer Center

location_facility: London Health Sciences Centre · Victoria Hospital; Department of Medicine

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: Beijing Children's Hospital, Capital Medical University; Oncological Surgery Department

location_facility: Consultants in Medical Oncology and Hematology

location_facility: Sourasky / Ichilov Hospital; Dept. of Oncology

location_facility: Children's Hospital Colorado; Center For Cancer/Blood Disorder

location_facility: Praxis für Hämatologie, Onkologie und Palliativmedizin

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Georg-August-Uniklinik ; Zentrum Innere Medizin Abt. Hämatologie & Onkologie

location_facility: Vall d?Hebron Institute of Oncology (VHIO), Barcelona

location_facility: Metro-Minnesota Community Oncology Research Consortium

location_facility: Ospedale Pediatrico Bambino Gesù - IRCCS; Dipartimento di Onco-Ematologia Pediatrica

location_facility: Kaiser Permanente Los Angeles; Clinic/Infusion -LA

location_facility: START Madrid-FJD, Hospital Fundacion Jimenez Diaz

location_facility: Policlinico Universitario Agostino Gemelli IRCCS; UOS Fase 1

location_facility: Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica

location_facility: Taipei Veterans General Hospital; Department of Oncology

location_facility: Chang Gung Memorial Hospital-Linkou; Dept of Oncology

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers

location_facility: Universitätsklinikum Freiburg Medizinische Klinik Innere Medizin I

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

location_facility: Centre Oscar Lambret; Service de Pediatrie

location_facility: Uniklinikum, Comprehensive Cancer Center Mainfranken; Interdisziplinäres Studienzentrum mit ECTU

location_facility: New York Cancer and Blood Specialists - Setauket Medical Oncology

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Seoul National University Bundang Hospital

location_facility: National Taiwan University Hospital; Oncology

location_facility: Seoul National University Hospital- Adult Site

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: West China Hospital - Sichuan University

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Montefiore Einstein Center for Cancer Care

location_facility: Inselspital, Klinik und Poliklinik für Medizinische Onkologie

location_facility: National Cheng Kung University Hospital; Oncology

location_facility: Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie

location_facility: Universtitätsklinikum Ulm; Klinik für Innere Medizin III

location_facility: National Cancer Centre; Medical Oncology

location_facility: Kinghorn Cancer Centre; St Vincents Hospital

location_facility: Cancer Treatment Centers of America; Eastern Regional Medical Center

location_facility: SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm.

location_facility: Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita

location_facility: University of California at San Francisco

location_facility: Miami Cancer Institute of Baptist Health, Inc.

location_facility: Azienda Ospedaliera Meyer; Centro di Eccellenza di Oncologia ed Ematologia Pediatrica

location_facility: Royal Darwin Hospital; Alan Walker Cancer Centre

location_facility: Christiana Care Health Srvcs; Helen F Graham Can Center

location_facility: Northwest Medical Specialties, PLLC; Research Department

location_facility: Seoul National University Hospital- Pediatric Site

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

title: Tumor-Agnostic Precision Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Japan
Canada
France
Portugal
Hong Kong
Denmark
Switzerland
United States
Belgium
China
Puerto Rico
Italy
United Kingdom
Singapore
Netherlands
Korea, Republic of
Spain
Taiwan
Israel


summary: NSCLC comprises of approximately 84 percent (%) of all lung cancers and is often diagnosed at advanced stage due to poor prognosis. Dostarlimab is an immunoglobulin G (IgG)4 kappa humanized monoclonal antibody (mAb) that binds with high affinity to programmed cell death protein 1 (PD 1), resulting in inhibition of binding to programmed death ligand 1 (PD L1) and programmed death ligand 2 (PD L2). This study aims to compare the efficacy and safety PD-1 inhibitors dostarlimab and pembrolizumab, when administered in combination with chemotherapy (pemetrexed, cisplatin and carboplatin), in participants with non-squamous NSCLC without a known sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or receptor tyrosine kinase-1 (ROS-1) mutation, BRAF V600E mutation, or other genomic aberration for which an approved targeted therapy is available. A total of approximately 240 participants will be enrolled in the study for a period of 5 years.

ReferenceCitation: Austin D, Melhem M, Gandhi Y, Lu S, Visser S. Comparative analysis of PD-1 target engagement of dostarlimab and pembrolizumab in advanced solid tumors using ex vivo IL-2 stimulation data. CPT Pharmacometrics Syst Pharmacol. 2023 Jan;12(1):87-94. doi: 10.1002/psp4.12878. Epub 2022 Nov 16.

title: A Randomized, Phase 2, Double-blind Study to Evaluate the Efficacy of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Metastatic Non-Squamous Non-Small Cell Lung Cancer

location_country:
Germany
Italy
Poland
Argentina
Romania
Brazil
United States
Korea, Republic of
Spain
Chile
Taiwan
France


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Subjects With Amyotrophic Lateral Sclerosis (ALS)

summary: This is a 24-month, Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS)

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
Germany
Ireland
Italy
Poland
United Kingdom
Australia
Japan
Netherlands
Belgium
United States
Spain
Czechia
Ukraine
France

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Centre of Reconstructive and Restorative Medicine (University Clinic) Odessa National Medical University

location_facility: National Hospital Organization Iou National Hospital

location_facility: Medizinische Hochschule Hannover Klinik für Neurologie

location_facility: Ospedale Niguarda - Nemo Clinical Center - Fondazione Serena Onlus

location_facility: Universitaire Ziekenhuizen Leuven (UZ Leuven)

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: SI Institute of Neurology, Psychiatry and Narcology of NAMSU

location_facility: University Hospitals Sussex NHS Foundation Trust

location_facility: Ospedale Civile S. Agostino Estense di Modena, Azienda Ospedaliero Universitaria di Modena

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

location_facility: Niigata National Hospital National Hospital Organization

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: National Hospital Organization Higashinagoya National Hospital

location_facility: National Hospital Organization Hyogo-Chuo National Hospital

location_facility: St George's University Hospitals NHS Foundation Trust

location_facility: National Hospital Organization Okinawa National Hospital

location_facility: Maurice Wohl Clinical Neuroscience Institute, King's College London

location_facility: Universitätsmedizin Rostock, Klinik und Poliklinik für Neurologie

location_facility: Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: Uniwersytecki Szpital Kliniczny w Olsztynie Klinika Neurologii

location_facility: National Hospital Organization Higashisaitama National Hospital

location_facility: Nueor-Immunology Clinical Researh Education and Support Service (N-CRESS), Austin Health

location_facility: National Hospital Organization Omuta National Hospital


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal Function

acronym: ALIGN

summary: The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal function.

lead_sponsor: Chinook Therapeutics U.S., Inc.

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Czechia
Canada
France
Colombia
Portugal
Hong Kong
United States
India
China
Italy
United Kingdom
Korea, Republic of
Spain
Taiwan

location_facility: CHU de Grenoble - Hopital Albert Michallon

location_facility: William Osler Health System- Brampton Civic Hospital

location_facility: The First A ffliated Hospital of Baotou Medical College, Inner Mangolia University of Science and Technology

location_facility: Nanfang Hospital of Southern Medical University

location_facility: Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

location_facility: Hospital das Clínicas Universidade Federal de Minas Gerais - UFMG

location_facility: Renji Hospital Shanghai Jiaotong University School of Medicine

location_facility: Pelican Point Dialysis - DaVita Clinical Research

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

location_facility: Dokkyo Medical University - Saitama Medical Center

location_facility: Nil Ratan Sircar Medical College & Hospital

location_facility: Istituto di Ricerche Farmacologiche Mario Negri

location_facility: Fujian Medical University Union Hospital

location_facility: National Taiwan University Hospital Hsin-Chu Branch

location_facility: The First Affiliated Hospital Xinjiang Medical University

location_facility: The Third Xiangya Hospital of Central South University

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Centro de Investigaciones Medicas Mar del Plata

location_facility: San Antonio Kidney Disease Center Physicians Group, P.L.L.C

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Brookview Hills Research Associates, LLC

location_facility: Kokura Memorial Hospital (Kokura Kinen Hospital)

location_facility: Severance Hospital, Yonsei University Hospital

location_facility: Nephrology Associates Of Northern Virginia

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: The First Affiliated Hospital Anhui Medical University

location_facility: UCLA Clinical and Translational Research Center

location_facility: North Bristol HNS Trust, Clinical Research Centre

location_facility: University of Louisville Physicians- Kidney Disease Program

location_facility: Centro Hospitalar de Lisboa Ocidental EPE - Hospital Santa Cruz

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Mountain Kidney and Hypertension Associates

location_facility: Centro Hospitalar do Medio Tejo (CHMT), E.P.E.

location_facility: The Affiliated Hospital of Nantong University

location_facility: Samodzielny Publiczny ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital das Clinicas da Faculdade de Medicina da USP

location_facility: Kyung Hee University Hospital at Gangdong

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Clinica de Nefrologia Urologia y Enf. Cardiovasculares

location_facility: The Second Hospital of Anhui Medical University

location_facility: St. Marianna University (SMU) School of Medicine

location_facility: General Hospital of Ningxia Medical University


title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Adult Patients With Primary Sjögren's Syndrome (pSjS)

acronym: phaethuSA

summary:
Primary Objective:

To evaluate the therapeutic efficacy of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with primary Sjögren's syndrome (pSjS), assessed by the change of the European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI)

Secondary Objectives:

To evaluate the therapeutic efficacy of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS
To evaluate the therapeutic efficacy on fatigue of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS
To evaluate the pharmacokinetic (PK) exposure of one dose level of SAR441344 over 12 weeks in adult patients with pSjS
To evaluate the safety and tolerability of one dose level of SAR441344 versus placebo in adult patients with pSjS as determined by adverse events (AEs)
To evaluate the local tolerability of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS
To evaluate the safety and tolerability of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS determined by electrocardiogram, vital signs, and laboratory evaluations
To measure the immunogenicity of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS

This is a multicenter, randomized, double blind, placebo controlled, parallel group proof of concept Phase 2 study to evaluate the therapeutic efficacy of SAR441344 in adult patients with primary Sjögren's syndrome (pSjS), as well as safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD).

Study visit frequency: every 2 weeks in the treatment period and every 4 weeks in the follow-up period.
The total duration of the study will be 24 weeks (28 weeks including maximum screening duration) for each participant, including a 12-week treatment period and a 12-week follow-up period.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi

location_country:
Germany
Hungary
Argentina
Mexico
Belgium
United States
Korea, Republic of
Spain
Chile
Taiwan
Canada
France

location_facility: Prolato Clinical Research Center Site Number : 8400009

location_facility: Ramesh C. Gupta, M.D. Site Number : 8400007

location_facility: Altoona Center For Clinical Research Site Number : 8400001

location_facility: Omega Research Consultants Debary Site Number : 8400005

location_facility: Tekton Research, Inc. Site Number : 8400002


title: A Dual-cohort, Open-label, Phase 2 Study of Brentuximab Vedotin and CHP (A+CHP) in the Frontline Treatment of Subjects With Peripheral T-cell Lymphoma (PTCL) With Less Than 10% CD30 Expression

summary: This clinical trial will study brentuximab vedotin with CHP to find out if the drugs work for people who have certain types of peripheral T-cell lymphoma (PTCL). It will also find out what side effects occur when brentuximab vedotin and CHP are used together. A side effect is anything the drugs do besides treating cancer. CHP is a type of chemotherapy that uses three drugs (cyclophosphamide, doxorubicin, and prednisone). CHP is approved by the FDA to treat certain types of PTCL.

lead_sponsor: Seagen Inc.

location_country:
Italy
United Kingdom
United States
Spain
Czechia
France

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Stanford Cancer Center / Blood and Marrow Transplant Program

location_facility: Virginia Commonwealth University Medical Center

location_facility: CHD Vendee, Site de La Roche-sur-Yon, Les Oudairies

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Virginia Oncology Associates - Virginia Beach

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Azienda Ospedaliera Universitaria San Martino