title: An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, as First-Line Treatment in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

summary:
The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).

The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Japan
Philippines
South Africa
Czechia
Poland
Russian Federation
Australia
Turkey
Mexico
Norway
Malaysia
Sweden
Brazil
Canada
Guatemala
Hungary
China
Germany
Denmark
Taiwan
Ireland
Finland
Thailand
Korea, Republic of
France
Chile
Colombia

location_facility: Roswell Park Cancer Institute ( Site 0032)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2405)

location_facility: Okayama University Hospital ( Site 5017)

location_facility: Dartmouth Hitchcock Medical Center ( Site 0075)

location_facility: Kindai University Hospital- Osakasayama Campus-Urology ( Site 5010)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 2301)

location_facility: Fakultni Thomayerova nemocnice ( Site 2201)

location_facility: Tokyo Women's Medical University Adachi Medical Center ( Site 5023)

location_facility: Sunnybrook Research Institute ( Site 0116)

location_facility: Centro Regional de Sub Especialidades Medicas SA ( Site 0704)

location_facility: Beth Israel Deaconess Medical Center ( Site 0089)

location_facility: Nara Medical University Hospital ( Site 5002)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2420)

location_facility: Hacettepe Universitesi Tıp Fakultesi ( Site 2903)

location_facility: Klinicki Bolnicki Centar Zagreb ( Site 3200)

location_facility: Confluence Health | Wenatchee Valley Hospital & Clinics ( Site 0061)

location_facility: Jasz - Nagykun Szolnok megyei Hetenyi Geza Korhaz - Rendelointezet ( Site 2300)

location_facility: Fakultni nemocnice u sv. Anny v Brne ( Site 2205)

location_facility: Lahey Hospital & Medical Center ( Site 0090)

location_facility: FBHI Privolzhsky District Medical Center of the FMBA ( Site 2611)

location_facility: Shanghai Tenth People's Hospital ( Site 6023)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 2407)

location_facility: Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 4406)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0610)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 2704)

location_facility: Norrlands Universitetssjukhus ( Site 2106)

location_facility: Clinical oncology dispensary of Dnipro ( Site 2700)

location_facility: Kyiv City Clinical Oncology Center ( Site 2706)

location_facility: Cardinal Santos Medical Center ( Site 4603)

location_facility: Cancercare Rondebosch Oncology ( Site 3005)

location_facility: Universiti Malaya Medical Centre ( Site 4300)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 2001)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 3006)

location_facility: Lviv State Regional Oncological Center ( Site 2712)

location_facility: The University of Alabama at Birmingham ( Site 0010)

location_facility: Korea University Anam Hospital ( Site 4206)

location_facility: Centro Avançado de Tratamento Oncológico- CENATRON-Clinical Research ( Site 0303)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 2609)

location_facility: Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 2711)

location_facility: New England Cancer Specialists ( Site 0082)

location_facility: BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0300)

location_facility: Centro de Pesquisas Clinicas em Oncologia ( Site 0306)

location_facility: Centro Medico Integral de Cancerologia CEMIC ( Site 0701)

location_facility: The First Affiliated Hospital, Zhejiang University ( Site 6024)

location_facility: City clinical oncological dispensary ( Site 2605)

location_facility: Fondazione Policlinico Universitario A. Gemelli ( Site 1414)

location_facility: Rush University Medical Center ( Site 0040)

location_facility: Helse Bergen HF - Haukeland Universitetssykehus ( Site 2002)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 3009)

location_facility: Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 6000)

location_facility: Fundacion Cardiovascular de Colombia ( Site 0506)

location_facility: Nemocnice AGEL Novy Jicin a.s. ( Site 2202)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 1504)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0505)

location_facility: Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 2715)

location_facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 2621)

location_facility: Akershus universitetssykehus ( Site 2000)

location_facility: National Taiwan University Hospital ( Site 4401)

location_facility: Taipei Veterans General Hospital ( Site 4402)

location_facility: Advent Health Hematology & Oncology ( Site 0003)

location_facility: Vaal Triangle Oncology Centre ( Site 3010)

location_facility: Administradora Country SA - Clinica del Country ( Site 0504)

location_facility: Instituto Nacional de Cancerologia ( Site 0602)

location_facility: Cedars Sinai Medical Center ( Site 0027)

location_facility: The Second Affiliated Hospital of Soochow University-Urology ( Site 6025)

location_facility: University of Mississippi Medical Center ( Site 0037)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 1502)

location_facility: Hospital Universitario 12 de Octubre ( Site 1505)

location_facility: Chongqing University Cancer Hospital ( Site 6009)

location_facility: Severance Hospital Yonsei University Health System ( Site 4204)

location_facility: Klinicki bolnicki centar "Sestre milosrdnice" ( Site 3201)

location_facility: Hokkaido University Hospital ( Site 5013)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2901)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 4405)

location_facility: Oncólogos del Occidente S.A ( Site 0501)

location_facility: Tokyo Medical And Dental University Medical Hospital-Urology ( Site 5009)

location_facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 6003)

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S

location_facility: Kuopion Yliopistollinen Sairaala ( Site 1803)

location_facility: Universitaetsklinik fuer Urologie ( Site 1300)

location_facility: Oregon Health & Science University ( Site 0071)

location_facility: HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005)

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University ( Site 6014)

location_facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2309)

location_facility: Ankara Universitesi Tip Fakultesi ( Site 2902)

location_facility: Henan Cancer Hospital-Urology ( Site 6006)

location_facility: Massachusetts General Hospital ( Site 0094)

location_facility: Trakya University Medical Faculty Balkan Oncology Hospital ( Site 2906)

location_facility: Klinički Bolnički Centar Split ( Site 3202)

location_facility: Dana Farber Cancer Institute ( Site 0093)

location_facility: Centro Investigacion Cancer James Lind ( Site 0402)

location_facility: MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 2710)

location_facility: Charite Universitaetsmedizin Berlin ( Site 1301)

location_facility: Sidney Kimmel Center for Prostate and Urologic Cancers ( Site 0055)

location_facility: Saitama Medical University International Medical Center ( Site 5015)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0117)

location_facility: National Cheng Kung University Hospital ( Site 4404)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2900)

location_facility: Sykehuset Østfold HF Kalnes ( Site 2003)

location_facility: University of California Irvine ( Site 0029)

location_facility: West China Hospital Sichuan University-Urology Surgery ( Site 6016)

location_facility: Azienda Ospedaliera Policlinico di Bari ( Site 1411)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1501)

location_facility: University of Tennessee Medical Center Knoxville ( Site 0019)

location_facility: Chernihiv Medical Center of Modern Oncology ( Site 2709)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 0308)

location_facility: The Loginov Moscow Clinical Scientific Center ( Site 2604)

location_facility: Univ. Pretoria and Steve Biko Academic Hospitals ( Site 3002)

location_facility: Clinique Ambroise Pare Beuvry ( Site 1213)

location_facility: Tianjin Medical University Cancer Institute and Hospital ( Site 6029)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0302)

location_facility: Institut Kanser Negara - National Cancer Institute ( Site 4302)

location_facility: Orszagos Onkologiai Intezet ( Site 2304)

location_facility: Northwell Health- Monter Cancer Center ( Site 0013)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 2102)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2617)

location_facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

location_facility: Azienda Ospedaliera S. Maria di Terni ( Site 1410)

location_facility: Ospedale San Raffaele-Oncologia Medica ( Site 1417)

location_facility: Markusovszky Egyetemi Oktatokorhaz ( Site 2303)

location_facility: Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego ( Site 2406)

location_facility: Norton Cancer Institute - St. Matthews ( Site 0065)

location_facility: Centro de Investigacion Clinica de Oaxaca ( Site 0605)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 2412)

location_facility: Taichung Veterans General Hospital ( Site 4403)

location_facility: The First Hospital of Jiaxing ( Site 6033)

location_facility: BC Cancer - Vancouver Center ( Site 0120)

location_facility: Tallaght University Hospital ( Site 6100)

location_facility: Ningbo First Hospital-Urology ( Site 6028)

location_facility: Fundacion Arturo Lopez Perez ( Site 0400)

location_facility: Sapporo Medical University Hospital ( Site 5008)

location_facility: National Cancer Center Hospital East ( Site 5000)

location_facility: Hospital Clinico San Carlos ( Site 1503)

location_facility: The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 6021)

location_facility: Instituto de Cancerología S.A Clínica de las Americas (ICCLA) ( Site 0500)

location_facility: The First Affiliated Hospital of Nanchang University ( Site 6019)

location_facility: Instituto Nacional de Cancerología E.S.E. ( Site 0503)

location_facility: Helios Kliniken Schwerin GmbH ( Site 1302)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2904)

location_facility: Chungnam National University Hospital ( Site 4205)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1409)

location_facility: Radomskie Centrum Onkologii ( Site 2418)

location_facility: Ivano-Frankivsk Regional Hospital-Urology department ( Site 2707)

location_facility: Hamamatsu University School of Medicine University Hospital ( Site 5004)

location_facility: Moscow Oncological Clinical Dispensary #1 ( Site 2619)

location_facility: CH Lyon Sud Hospices Civils de Lyon ( Site 1203)

location_facility: The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 6036)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 2100)

location_facility: Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1404)

location_facility: Niigata University Medical & Dental Hospital ( Site 5024)

location_facility: University Cancer & Blood Center, LLC ( Site 0057)

location_facility: Mary Potter Oncology Centre, Little Company of Mary Hospital ( Site 3001)

location_facility: Regional Oncology Center of Kharkiv ( Site 2708)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2308)

location_facility: Masarykuv onkologicky ustav ( Site 2203)

location_facility: Vanderbilt University Medical Center ( Site 0069)

location_facility: Sanatorio Nuestra Senora del Pilar ( Site 0702)

location_facility: The Second Hospital of Tianjin Medical University ( Site 6032)

location_facility: Nippon Medical School Hospital ( Site 5006)

location_facility: Cancer & Hematology Centers of Western Michigan ( Site 0018)

location_facility: Barts Health NHS Trust - St Bartholomew s Hospital ( Site 3116)

location_facility: Altay Regional Oncology Dispensary ( Site 2610)

location_facility: Tokushima University Hospital-Department of Urology ( Site 5019)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 3000)

location_facility: Guangzhou First People's Hospital ( Site 6007)

location_facility: Hospital Universitario de Girona Doctor Josep Trueta ( Site 1500)

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2905)

location_facility: Emory University Winship Cancer Institute ( Site 0012)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 1412)

location_facility: Ivanovo Regional Oncology Dispensary ( Site 2615)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 0310)

location_facility: UCLA Hematology Oncology Santa Monica ( Site 0048)

location_facility: Seoul National University Hospital ( Site 4201)

location_facility: Soerlandet sykehus HF Kristiansand ( Site 2007)


type: Other Identifier

type: EudraCT Number

title: A Phase 2, Multicenter, Randomized Study to Compare the Efficacy and Safety of MK-7684A or MK-7684A Plus Docetaxel Versus Docetaxel Monotherapy in the Treatment of Participants With Metastatic Non-small Cell Lung Cancer With Progressive Disease After Treatment With a Platinum Doublet Chemotherapy and Immunotherapy

summary: The main purpose of this study is to compare pembrolizumab/vibostolimab coformulation (MK-7684A) plus docetaxel or pembrolizumab/vibostolimab coformulation to normal saline placebo plus docetaxel. Participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti- programmed cell death 1 (PD-1)/ programmed cell death ligand 1(PD-L1) monoclonal antibody (mAb). MK-7684A is a coformulation product of pembrolizumab/vibostolimab. The dual primary hypotheses of the study are pembrolizumab/vibostolimab coformulation plus docetaxel and pembrolizumab/vibostolimab coformulation is superior to normal saline placebo plus docetaxel with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Denmark
Poland
Taiwan
Brazil
Spain
Italy
Austria
Australia
Russian Federation
Argentina
Finland
Switzerland
Thailand
Korea, Republic of
United States
France
Israel
Malaysia
Belgium
Germany

location_facility: Grand Hôpital de Charleroi-Oncology & Hematology ( Site 0337)

location_facility: Hattiesburg Clinic Hematology/Oncology ( Site 2511)

location_facility: ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0400)

location_facility: Chang Gung Memorial Hospital at Kaohsiung ( Site 2303)

location_facility: Hospital de la Santa Creu i Sant Pau-Oncología Médica ( Site 2102)

location_facility: Helios Klinikum Emil von Behring Berlin-Zehlendorf ( Site 1106)

location_facility: Centre Hospitalier d'Avignon-Service d'Oncologie médicale et d'hématologie clinique ( Site 1004)

location_facility: Mercy Research - David C. Pratt Cancer Center ( Site 2532)

location_facility: Ospedale Regionale Bellinzona e Valli ( Site 2203)

location_facility: Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0005)

location_facility: Mackay Memorial Hospital-Chest Medicine ( Site 2305)

location_facility: Shaare Zedek Medical Center-Oncology ( Site 1206)

location_facility: Medizinische Universität Graz ( Site 0201)

location_facility: Montefiore- Einstein Center for Cancer Care-Oncology ( Site 2509)

location_facility: Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 2103)

location_facility: Instituto de Oncología de Rosario ( Site 0003)

location_facility: Cedars-Sinai Medical Center ( Site 2522)

location_facility: Centro de Oncología e Investigación de Buenos Aires ( Site 0008)

location_facility: Chungbuk National University Hospital-Internal medicine ( Site 2004)

location_facility: Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (

location_facility: Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1306)

location_facility: Gold Coast University Hospital-Clinical Trials Service ( Site 0106)

location_facility: Taichung Veterans General Hospital-Chest ( Site 2307)

location_facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2101)

location_facility: Hospital Privado de Comunidad ( Site 0004)

location_facility: Ospedale San Raffaele-Oncologia Medica ( Site 1305)

location_facility: Jessa Ziekenhuis-Pulmonology & Thoracic Oncology ( Site 0338)

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga-Oncologia Polmonare ( Site 1300)

location_facility: Hospital Nossa Senhora da Conceição ( Site 0403)

location_facility: Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1308)

location_facility: Helios Dr. Horst Schmidt Kliniken ( Site 1108)

location_facility: Hospital Privado Universitario de Córdoba ( Site 0001)

location_facility: St Francis Cancer Center-Research Office ( Site 2531)

location_facility: CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 1008)

location_facility: Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1006)

location_facility: Moscow Clinical Research Center-Chemotherapy department ( Site 1910)

location_facility: University Malaya Medical Centre ( Site 1501)

location_facility: Klinikverbund Allgaeu gGmbH ( Site 1109)

location_facility: NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 2302)

location_facility: N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( S

location_facility: Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0204)

location_facility: Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1911)

location_facility: Central Clinical Hospital of the Presidential Administrative Department ( Site 1902)

location_facility: Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1301)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1303)

location_facility: Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary ( Site 1908)

location_facility: Asan Medical Center-Oncology ( Site 2000)

location_facility: Hadassah Medical-Oncology department ( Site 1912)

location_facility: AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0333)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 2400)

location_facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0002)

location_facility: Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0203)

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1009)

location_facility: Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1307)

location_facility: Centro de Tratamento de Tumores Botafogo - CTTB-Pesquisa Clínica ( Site 0402)

location_facility: GBUZ LOKB-Oncology department #1 ( Site 1905)

location_facility: HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit

location_facility: Sygehus Soenderjylland-Kraeftambulatoriet ( Site 0705)

location_facility: National Taiwan University Hospital-Oncology ( Site 2304)

location_facility: Turku University Hospital-The Department of Pulmonary Medicine ( Site 0905)

location_facility: Mercy Research - Cancer and Hematology Center ( Site 2535)

location_facility: Hospital Tengku Ampuan Afzan ( Site 1500)

location_facility: Fiona Stanley Hospital-Medical Oncology ( Site 0102)

location_facility: Rambam Health Care Campus-Oncology ( Site 1203)

location_facility: Odense Universitetshospital ( Site 0700)

location_facility: Seoul National University Bundang Hospital ( Site 2003)

location_facility: Baptist Health Lexington-Research ( Site 2502)

location_facility: University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 2526)

location_facility: Tampereen yliopistollinen sairaala-Oncology ( Site 0906)

location_facility: The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2005)

location_facility: Oulun yliopistollinen sairaala ( Site 0902)

location_facility: Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 1909)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Ongoing


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

status: Recruiting

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

lead_sponsor: GlaxoSmithKline

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


ipd_sharing: No

intervention_type: Drug

title: An Open-Label Study of Regorafenib in Combination With Pembrolizumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma (HCC) After PD1/PD-L1 Immune Checkpoint Inhibitors

lead_sponsor: Bayer

source: euctr

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.

enrollment_type: Actual

location_country:
Spain
Italy
Korea, Republic of
United States
Israel
France
Japan
Germany

location_facility: Japanese Red Cross Society Musashino Red Cross Hospital

location_facility: University of Miami Miller School of Medicine

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: University of California Irvine Medical Center

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

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

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Hospital General Universitario Gregorio Marañón | Digestivo

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Medical Oncology Hematology Consultants, PA

location_facility: Klinikum der Universität München Grosshadern

summary:
Researchers are looking for a better way to treat people suffering from liver cancer which may have spread to nearby tissue and is unlikely to be cured or controlled with treatment (advanced metastatic hepatocellular carcinoma, HCC). 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 will learn more about the trial treatment, regorafenib, in a small number of participants. They will study the results when the trial treatment is taken with another cancer treatment called pembrolizumab.

There will be 2 parts to this trial. The part 1 (pilot phase) will include about 52 men and women. The part 2 (expansion phase) will include about 67 men and women. All of the participants will have HCC and will be aged 18 years or older. All of the participants will have tried other treatments that did not help their HCC. These other treatments (PD-1/PD-L1 Immune Checkpoint Inhibitors) are designed to work by stopping the activity of certain proteins in the immune system thought to play a role in HCC.

During both parts of the trial, the participants will take regorafenib and receive pembrolizumab. In the pilot phase, there will be 2 groups of participants. The group that each participant joins will be based on the treatment they already received for their HCC. The researchers will review the results in each group to learn if regorafenib and pembrolizumab are helping one group of participants more than others. Outcome of this review will determine the population to be treated in the expansion phase.


title: A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)

summary: This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.

ReferenceType: derived

ReferenceCitation: Eyre TA, Shah NN, Dreyling M, Jurczak W, Wang Y, Cheah CY, Song Y, Gandhi M, Chay C, Sharman J, Andorsky DJ, Messersmith HM, Ruppert AS, Muthig VA, Ito R, Wang ML. BRUIN MCL-321: phase III study of pirtobrutinib versus investigator choice of BTK inhibitor in BTK inhibitor naïve mantle cell lymphoma. Future Oncol. 2022 Nov 15. doi: 10.2217/fon-2022-0976. [Epub ahead of print] Review.

ReferenceCitation: Ito R, Eyre TA, Shah NN, Gouill SL, Dreyling M, Vandenberghe E, Jurczak W, Wang Y, Cheah CY, Gandhi M, Chay C, Sharman J, Andorsky DJ, Song Y, Stark A, Muthig V, Wang ML. MCL-135 BRUIN MCL-321, a Phase 3 Open-Label, Randomized Study of Pirtobrutinib Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated, BTK Inhibitor Naïve Mantle Cell Lymphoma (Trial in Progress). Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S395-S396. doi: 10.1016/S2152-2650(22)01570-1.

lead_sponsor: Loxo Oncology, Inc.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Israel
Canada
Switzerland
China
Germany
Denmark
Taiwan
Ireland
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC

location_facility: Arizona Oncology Associates, P.C. - HOPE

location_facility: Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen

location_facility: Blood Institute of the Chinese Academy of Medical science

location_facility: Cancer Center Office of Clinical Research

location_facility: Beijing Chaoyang Hospital, Capital Medical University

location_facility: Icon Cancer Care - The Wesley Medical Centre

location_facility: Affiliated Tumor Hospital of Xinjiang Medical University

location_facility: Kobe City Medical Center General Hospital

location_facility: Wake Forest University School of Medicine

location_facility: The First Affiliated Hospital of Soochow University

location_facility: State Medical University named after I.P. Pavlov

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Presidio Ospedaliero Civile Santi Antonio e Biagio

location_facility: Willamette Valley Cancer Institute & Research Ctr.

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Centre hospitalier universitaire de Haut Leveque

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Southern Medical University Nanfang Hospital

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

location_facility: Mercy Health-Paducah Medical Oncology and Hematology

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Federal State Budgetary Institution "Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medico-Biological Agency

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Aarhus Universitetshospital, Aarhus Sygehus

location_facility: Shengjing Hospital of China Medical University

location_facility: Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte

location_facility: GUZ of Moscow City Clinical Hospital n.a. S.P. Botkin

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: West China Hospital of Sichuan University

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Pole Regionalde Cancérologie(CHU de Poitiers)

location_facility: Klinikum der Universität München Großhadern

location_facility: University of Kentucky Markey Cancer Center

location_facility: Kyoto Furitsu Medical University Hospital

location_facility: Hematology Oncology Associates Of Northern New Jersey

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

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: City Hospital, Nottingham University Hospitals

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu


type: Registry Identifier

title: A Phase 2 Randomized Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

summary: The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Poland
Austria
Australia
Russian Federation
Argentina
Turkey
Mexico
Brazil
Switzerland
Germany
Ireland
New Zealand
France
Chile
Netherlands

location_facility: Arkhangelsk Clinical Oncological Dispensary

location_facility: Medical Oncology Associates, PS (dba Summit Cancer Centers)

location_facility: Oncology Hematology West P.C. dba Nebraska Cancer Specialist

location_facility: Yale School of Medicine - Smilow Cancer Hospital

location_facility: FSBI &quot,Research Institute of Influenza named after A.A. Smorodintsev &quot,of the MoH of the Rus

location_facility: NYU Perlmutter Cancer Center (Long Island)

location_facility: The University of Texas Health Science Center at Tyler DBA UT Health East Texas Hope Cancer Center

location_facility: University of Cincinnati Cancer Institute


acronym: Autonomy

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants With Early Alzheimer's Disease

lead_sponsor: Janssen Research & Development, LLC

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:
Spain
United Kingdom
Australia
Canada
Sweden
United States
France
Belgium
Japan
Netherlands

location_facility: Washington University School of Medicine

location_facility: Cleveland Clinic Lou Revo Center for Brain Health

location_facility: Advanced Memory Research Institute of NJ

location_facility: The University of Texas Health Science Center at Houston

location_facility: Kobe City Medical Center General Hospital

location_facility: Wexner Medical Center at the Ohio State University

location_facility: Alzheimers Research and Treatment Center

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: The National Hospital for Neurology and Neurosurgery Centre

location_facility: Alexian Brothers Medical Center - Neuroscience Research Institute

location_facility: University of California San Diego Medical Center

location_facility: University of Arizona - Behavioral Neuroscience and Alzheimer's Clinic

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: University of South Florida - Health Byrd Alzheimer Institute

location_facility: Australian Alzheimer's Research Foundation Incorporated

location_facility: Palm Beach Neurology and Premier Research Institute

location_facility: Anil Nair dba Alzheimer's Disease Center

location_facility: National Center For Geriatrics And Gerontology

location_facility: University of Miami Miller School of Medicine

location_facility: Neuropsychiatric Research Center of SWFL

location_facility: National Hospital Organization Hizen Psychiatric Center

location_facility: GIGA Centre de Recherches du Cyclotron, Université de Liège

location_facility: HammondCare Neurodegenerative Clinical Trials - VIC

location_facility: Rijikai Medical Corporation Katayama Medical Clinic

location_facility: Toronto Memory Program (Neurology Research Inc.)

summary: The primary purpose of this study is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the Integrated Alzheimer's Disease Rating Scale (iADRS), a composite of cognition and function.


title: Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure (ACLF): iNdications and outComEs

acronym: CHANCE

summary: Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Alternative strategies, as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potential life-threatening complications in the donor.

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Gustot T, Fernandez J, Garcia E, Morando F, Caraceni P, Alessandria C, Laleman W, Trebicka J, Elkrief L, Hopf C, Solís-Munoz P, Saliba F, Zeuzem S, Albillos A, Benten D, Montero-Alvarez JL, Chivas MT, Concepción M, Córdoba J, McCormick A, Stauber R, Vogel W, de Gottardi A, Welzel TM, Domenicali M, Risso A, Wendon J, Deulofeu C, Angeli P, Durand F, Pavesi M, Gerbes A, Jalan R, Moreau R, Ginés P, Bernardi M, Arroyo V; CANONIC Study Investigators of the EASL-CLIF Consortium. Clinical Course of acute-on-chronic liver failure syndrome and effects on prognosis. Hepatology. 2015 Jul;62(1):243-52. doi: 10.1002/hep.27849. Epub 2015 May 29.

ReferenceCitation: Artru F, Louvet A, Ruiz I, Levesque E, Labreuche J, Ursic-Bedoya J, Lassailly G, Dharancy S, Boleslawski E, Lebuffe G, Kipnis E, Ichai P, Coilly A, De Martin E, Antonini TM, Vibert E, Jaber S, Herrerro A, Samuel D, Duhamel A, Pageaux GP, Mathurin P, Saliba F. Liver transplantation in the most severely ill cirrhotic patients: A multicenter study in acute-on-chronic liver failure grade 3. J Hepatol. 2017 Oct;67(4):708-715. doi: 10.1016/j.jhep.2017.06.009. Epub 2017 Jun 21.

ReferenceCitation: Sundaram V, Jalan R, Wu T, Volk ML, Asrani SK, Klein AS, Wong RJ. Factors Associated with Survival of Patients With Severe Acute-On-Chronic Liver Failure Before and After Liver Transplantation. Gastroenterology. 2019 Apr;156(5):1381-1391.e3. doi: 10.1053/j.gastro.2018.12.007. Epub 2018 Dec 18.

lead_sponsor: European Foundation for Study of Chronic Liver Failure

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Japan
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Argentina
India
Turkey
Mexico
Brazil
Canada
Switzerland
Germany
Taiwan
New Zealand
Korea, Republic of
France
Colombia
Netherlands

location_facility: Hospital das Clínicas da Universidade de São Paulo

location_facility: Queen Mary Hospital, The University of Hong Kong

location_facility: Institute for Clinical and Experimental Medicine

location_facility: Baylor College of Medicine (Scott & White)

location_facility: Medical University of Warsaw, Dept. of General, Transplant & Liver Surgery

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Scottish Liver Transplant Unit, Royal Infirmary

location_facility: University of Maryland School of Medicine

location_facility: Medical University of Vienna, Department of Transplant Surgery

location_facility: Irmandade Santa Casa de Misericórdia de Porto Alegre

location_facility: APHP Hôpitaux Universitaires Pitié Salpêtrière

location_facility: Hepato-Biliary-Pancreatic and Transplantation Centre

location_facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

location_facility: Auckland City Hospital- New Zealand Liver Transplant Unit

location_facility: Global Hospital. Super speciality & transplant centre

location_facility: Cedars-Sinai Comprehensive Transplant Center

location_facility: University Medical Center Groningen (UMCG)

location_facility: Hautepièrre Hospital, Service de Réanimation Médicale

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: University of Toronto, Multiorgan Transplant Program

location_facility: S.Orsola Hospital - Alma Mater Studiorum University of Bologna

location_facility: University Medical Center, Hamburg Eppendorf

intervention_type: Other


acronym: Phase 3 Study of MK-6482 in Combination With Lenvatinib Versus Cabozantinib for Treatment of RCC

title: An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination With Lenvatinib (MK-7902) vs Cabozantinib in Participants With Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Brazil
Canada
Switzerland
Germany
Ireland
Finland
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Kindai University Hospital- Osakasayama Campus-Urology ( Site 5010)

location_facility: Royal United Hospital Bath England ( Site 3108)

location_facility: Aberdeen Royal Infirmary-Department of Oncology ( Site 3105)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 1602)

location_facility: University of Texas, Southwestern Medical Center ( Site 0015)

location_facility: HELIOS Klinikum Berlin-Buch ( Site 1311)

location_facility: Hadassah Medical-Oncology department ( Site 2609)

location_facility: Nara Medical University Hospital ( Site 5002)

location_facility: Ospedale Maggiore Borgo Trento ( Site 1408)

location_facility: Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 0093)

location_facility: Tulane University School of Medicine ( Site 0098)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0114)

location_facility: Confluence Health | Wenatchee Valley Hospital & Clinics ( Site 0061)

location_facility: Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1604)

location_facility: Antoni van Leeuwenhoek Ziekenhuis ( Site 1901)

location_facility: Ivanovo Regional Oncology Dispensary ( Site 2616)

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 2618)

location_facility: Helios Klinikum Erfurt GmbH ( Site 1315)

location_facility: Lahey Hospital & Medical Center ( Site 0090)

location_facility: Niigata University Medical & Dental Hospital ( Site 5013)

location_facility: The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0116)

location_facility: Mater Private Hospital - Dublin ( Site 3202)

location_facility: Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1200)

location_facility: Yokohama City University Hospital ( Site 5007)

location_facility: Clínica Vida Fundación - Sede Poblado ( Site 0505)

location_facility: Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1508)

location_facility: Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1909)

location_facility: Azienda Ospedaliera Policlinico di Bari ( Site 1402)

location_facility: Mater Misericordiae University Hospital ( Site 3201)

location_facility: UCLA Hematology/Oncology - Santa Monica ( Site 0048)

location_facility: Ironwood Cancer & Research Centers ( Site 0077)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0311)

location_facility: Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 3107)

location_facility: Rush University Medical Center ( Site 0040)

location_facility: Klinik Ottakring-1.Medizinische Abteilung - Zentrum für Onkologie und Hämatologie ( Site 1031)

location_facility: Azienda Ospedaliera S. Maria di Terni ( Site 1401)

location_facility: Medical Oncology Ospedale San Donato ( Site 1404)

location_facility: Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 1001)

location_facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0003)

location_facility: Lehigh Valley Hospital- Cedar Crest-Oncology Clinical Trials ( Site 0056)

location_facility: Sanatorio Británico-Clinical Oncology Department ( Site 0802)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 1406)

location_facility: Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 3106)

location_facility: Cedars Sinai Medical Center ( Site 0027)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0102)

location_facility: Universitaetsklinikum Aachen AOER ( Site 1317)

location_facility: Universitaetsklinikum Frankfurt ( Site 1301)

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1407)

location_facility: NCT-Department of Medical Oncology ( Site 1320)

location_facility: Blue Ridge Cancer Care - Roanoke ( Site 0043)

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego ( Site 2401)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2402)

location_facility: FSBI United Hospital with Polyclinic ( Site 2613)

location_facility: Georgetown University Medical Center ( Site 0006)

location_facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1218)

location_facility: University of Vermont Medical Center ( Site 0001)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1201)

location_facility: HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005)

location_facility: Volgograd Regional Uronephrological Center ( Site 2615)

location_facility: St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0095)

location_facility: Yaroslavl Regional Cancer Hospital-Oncology ( Site 2619)

location_facility: Krankenhaus Martha Maria Halle-Doelau ( Site 1314)

location_facility: Krankenhaus der Barmherzigen Brüder Wien ( Site 1041)

location_facility: Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1904)

location_facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1507)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0055)

location_facility: Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 2203)

location_facility: Centro Gaucho Integrado de Oncologia ( Site 0304)

location_facility: University of Mississippi Medical Ctr ( Site 0037)

location_facility: Universitair Medisch Centrum Utrecht ( Site 1910)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - O-Klinika Onkologii Klinicznej ( Site 240

location_facility: Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0508)

location_facility: Fundación Cardiovascular de Colombia ( Site 0501)

location_facility: Cancer Partners of Nebraska ( Site 0086)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1410)

location_facility: CISSS de la Monteregie-Centre ( Site 0103)

location_facility: Chonnam National University Hwasun Hospital-Oncology ( Site 4203)

location_facility: Providence Saint John's Health Center ( Site 0083)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 0313)

location_facility: Hospital Británico de Buenos Aires-Oncology ( Site 0801)

location_facility: Complejo Hospitalario Universitario A Coruna ( Site 1502)

location_facility: Northwell Health- Monter Cancer Center ( Site 0013)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0078)

location_facility: Hospital Santa Creu i Sant Pau ( Site 1501)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2400)

location_facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

location_facility: Hospital Clinic i Provincial ( Site 1500)

location_facility: Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 4010)

location_facility: Norton Cancer Institute - St. Matthews ( Site 0065)

location_facility: Instituto Nacional de Cancerología-Clinical Oncology ( Site 0500)

location_facility: Asociación de Beneficencia Hospital Sirio Libanés ( Site 0804)

location_facility: SHI of Moscow City Oncology Clinical Hospital - 62 ( Site 2614)

location_facility: Istituti Clinici Scientifici Maugeri Spa ( Site 1403)

location_facility: Tokyo Medical And Dental University Medical Hospital ( Site 5009)

location_facility: Sapporo Medical University Hospital ( Site 5008)

location_facility: National Cancer Center Hospital East ( Site 5000)

location_facility: BC Cancer Vancouver-Clinical Trials Unit ( Site 0110)

location_facility: Hospital Clinico San Carlos ( Site 1504)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1400)

location_facility: Charite Universitaetsmedizin Berlin ( Site 1321)

location_facility: Hamamatsu University School of Medicine University Hospital ( Site 5004)

location_facility: Medizinische Universität Wien ( Site 1021)

location_facility: University Cancer & Blood Center, LLC ( Site 0057)

location_facility: Tampereen yliopistollinen sairaala ( Site 1801)

location_facility: IRCCS Ospedale San Raffaele ( Site 1409)

location_facility: Medizinische Universitätsklinik Graz ( Site 1051)

location_facility: Hospital Paulistano - Amil Clinical Research ( Site 0308)

location_facility: Universitaetsspital Zuerich ( Site 1601)

location_facility: Nippon Medical School Hospital ( Site 5006)

location_facility: Cancer & Hematology Centers of Western Michigan ( Site 0018)

location_facility: Peninsula Health Frankston Hospital ( Site 4001)

location_facility: Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 2200)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 1209)

location_facility: Tallaght University Hospital ( Site 3200)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1505)

location_facility: Amphia Hospital Location Molengracht ( Site 1912)

location_facility: Instituto Alexander Fleming ( Site 0800)

summary:
This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy.

The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Combination of PI3Kδ Inhibitor Parsaclisib and Ruxolitinib in Participants With Myelofibrosis

summary: The purpose of the study is to compare the efficacy of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Denmark
Poland
Spain
Italy
Austria
United Kingdom
Finland
Korea, Republic of
United States
France
China
Israel
Belgium
Japan
Germany
Norway
Turkey

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

location_facility: Davidoff Cancer Center Rabin Medical Center

location_facility: Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele

location_facility: Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris)

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: Tianjin Medical University General Hospital

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Aormn Hospital Hematology and Bmt Center

location_facility: The First Hospital of Lanzhou University

location_facility: Institut Catala Doncologia Ico - Hospital Duran I Reynals Location

location_facility: University of Kentucky - Markey Cancer Center

location_facility: Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)

location_facility: Universita Degli Studi Di Genova - Facolta Di Medicina E Chirurgia

location_facility: Centre Hospitalier de Versailles - Hopital Andre Mignot

location_facility: Kobe City Medical Center General Hospital

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

location_facility: Hospital General Universitario Vall D Hebron

location_facility: A.O. Universitaria Ospedale Di Circolo E Fondazione Macchi

location_facility: Aou San Giovanni Di Dio E Ruggi D'Aragona

location_facility: Hospital of the University of Occupation and Environmental Health

location_facility: Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

location_facility: Texas Oncology - Baylor Sammons Cancer Center

location_facility: Sutter Health Alta Bates Summit Medical Center Absmc Alta Bates Summit Comprehensive Cancer Center

location_facility: New Jersey Hematology Oncology Associates Llc

location_facility: University Hospital of North Midlands Nhs Trust

location_facility: Fujian Medical University Union Hospital

location_facility: The Affiliated Hospital of Inner Mongolia Medical University

location_facility: The Second Hospital of Hebei Medical University

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi

location_facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Providence Regional Medical Center Everett

location_facility: Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse

location_facility: Sheffield Teaching Hospitals Nhs Foundation Trust - Weston Park Hospital

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Barts Health NHS Trust - St. Bartholomews Hospital

location_facility: Ondokuz Mayis University Medicine Faculty

location_facility: The Catholic University of Korea Seoul St. Mary?S Hospital

location_facility: Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or

location_facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Samodzielny Publiczny Szpital Kliniczny Im. Andrzeja Mielckiego

location_facility: Hospital General Unviersitario de Alicante

location_facility: University College London Hospitals Nhs Foundation Trust

location_facility: Stamford Hospital - Medical Oncology Hematology

location_facility: Institute of Hematology and Transfusion Medicine

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: Xiangya Hospital Central South University

location_facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

location_facility: Westchester Medical Center Advanced Oncology and Infusion Center

location_facility: The First Affiliated Hospital of Zhejiang University

location_facility: Harbin Institute of Hematology and Oncology

location_facility: Peking University People'S Hospital (Pkuph) - Institute of Hematology

location_facility: Gazi University Hospital Gazi University Faculty of Medicine

location_facility: Azienda Sanitaria Universitaria Friuli Centrale Asu Fc

location_facility: Morristown Medical Center - Atlantic Health System


title: A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center, International Study of Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma (KUNLUN)

acronym: KUNLUN

summary: This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study to assess the efficacy and safety of durvalumab administered concurrently with dCRT in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).

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:
Poland
Taiwan
Brazil
Spain
Russian Federation
Mexico
Canada
Thailand
Vietnam
Korea, Republic of
United States
France
China
Peru
Belgium
Japan
Netherlands
Turkey

intervention_type: Radiation


acronym: PAPILLON

title: A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Poland
Portugal
Russian Federation
Australia
Puerto Rico
India
Israel
Turkey
Mexico
Malaysia
Brazil
Canada
Hungary
China
Germany
Taiwan
Thailand
Korea, Republic of
France

location_facility: Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie

location_facility: UPCO Unidade de Pesquisa Clinica em Oncologia

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: Chonnam National University Hwasun Hospital

location_facility: Orszagos Koranyi Tbc es Pulmonologiai Intezet

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Tianjin Medical University General Hospital

location_facility: Private Specialist Hospitals - MedPolonia

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

location_facility: Fundação Antônio Prudente - A.C. Camargo Cancer Center

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

location_facility: The Second Affiliated Hospital of Zhejiang University College of Medicine

location_facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: União Brasileira de Educação e Assistência-Hospital São Lucas da PUCRS

location_facility: Rajiv Gandhi Cancer Institute & Research Centre

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: Kobe City Medical Center General Hospital

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz

location_facility: Mexico Centre for Clinical Research, S.A. de C.V.

location_facility: Hospital Evangélico de Cachoeiro de Itapemirim

location_facility: The First Affiliated Hospital, Zhejiang University College of Medicine

location_facility: Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal

location_facility: Nizhny Novgorod Regional Oncological Dispensary

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

location_facility: Fujian Medical University Union Hospital

location_facility: Centro Hospitalar Universitario do Porto, EPE

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

location_facility: TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

location_facility: Başkent University Medical Faculty Adana Application and Research Center

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Municipal Institution 'Odesa Clinical Oncology Dispensary'

location_facility: Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

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

location_facility: Cancer hospital Chinese Academy of Medical Sciences, Shenzhen Center

location_facility: Langone Health at NYC University, NYU School of Medicine

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

location_facility: Oncology Medical Clinics AV Medical group

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

location_facility: Ministerio da Saude - Instituto Nacional do Cancer

location_facility: Pan American Center for Oncology Trials LLC

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Frederick Health Hospital - James M Stockman Cancer Institute

location_facility: Moscow Oncology Research Center n.a. Blokhin

location_facility: N.N. Petrov Research Institute Of Oncology

location_facility: National Hospital Organization Yamaguchi Ube Medical Center

location_facility: Saitama Medical University International Medical Center

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Shengjing Hospital of China Medical University

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: University of Mississippi Medical Center

location_facility: The First People's Hospital Of Changzhou

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Peking University International Hospital

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: Seoul National University Bundang Hospital

location_facility: State Medical Institution 'Republican Clinical Oncological Centre' at Republic of Tatarstan

location_facility: Yaroslavl Regional Clinical Oncology Hospital

location_facility: H. Lee Moffitt Cancer & Research Institute

location_facility: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Beijing Chest hospital, Capital medical university

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Harbin medical university cancer hospital

location_facility: Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken München-Gauting

location_facility: Krasnoyarsk Regional Oncology Dispensary

location_facility: Phramongkutklao Hospital and Medical College

location_facility: Songklanagarind Hospital, Prince of Songkla University

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: National Hospital Organization Himeji Medical Center

summary: The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.


title: A Phase III, Open-Label, Randomized Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Patients With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent Platinum-Based Chemoradiation

lead_sponsor: Hoffmann-La Roche

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:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Argentina
Israel
Turkey
Brazil
Canada
Hungary
China
Germany
Taiwan
Greece
New Zealand
Thailand
Korea, Republic of
France
Netherlands

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia

location_facility: Monument Health Rapid City Hospital, Inc.

location_facility: The First Affiliated Hospital to Henan University of Science and Technology

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Policlinico Universitario Campus Biomedico; U.O.C. di Radioterapia Oncologica

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit

location_facility: Ankara University Medical Faculty; Medikal Onkoloji

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: Pusan National University Yangsan Hospital

location_facility: Queen Elizabeth Hospital; Clinical Oncology

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

location_facility: Istanbul University Cerrahpasa Faculty of Medicine

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Fakultni nemocnice Olomouc; Pneumologicka klinika

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie

location_facility: Calderdale & Huddersfield Nhs Trust; Oncology

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: General Hospital "G.Papanikolaou"; Pulmonogy Clinic

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

location_facility: New York Oncology Hematology,P.C.-Albany

location_facility: Centro Integrado de Oncologia de Curitiba

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

location_facility: Beijing Chest Hospital; Oncology Department

location_facility: Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: Fujian Medical University Union Hospital

location_facility: Titan Health Partners LLC, d/b/a Astera Cancer Care

location_facility: Cliniche Gavazzeni SpA Humanitas Gavazzeni

location_facility: Medisch Centrum Haaglanden, locatie Antoniushove

location_facility: Leicester Royal Infirmary; Oncology Department

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

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

location_facility: Princess Margaret Hospital, Oncology; Department of Oncology

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.

location_facility: Universitaetsmedizin Goettingen; Abteilung Haematologie und Onkologie

location_facility: Eastern Connecticut Hematology and Oncology Associates; (ECHO)

location_facility: Medipol University MF; Oncology Department

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: IRCCS Istituto Regina Elena (IFO); Oncologia Medica B

location_facility: Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory

location_facility: Zhongda Hospital Affiliated to Southeast University

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Maidstone & Tonbridge Wells Hospital; Kent Oncology Center

location_facility: Hospital Son Llatzer; Servicio de Oncologia

location_facility: SMZ - Baumgartner Hohe, Otto-Wagner-Spital; 2.Interne Lungenabteilung

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie

location_facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie

location_facility: The Affiliated Hospital of Xuzhou Medical College

location_facility: Beijing Cancer Center; Renal Cancer And Melanoma Department.

location_facility: Karmanos Cancer Center; Department of Oncology

location_facility: The First Affiliated Hospital of Xiamen University

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

location_facility: National Taiwan Uni Hospital; Internal Medicine

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi; Ic Hastaliklari Anabiim Dali

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

location_facility: Adana Baskent University Medical Faculty; Oncology

location_facility: Gazi University Medical Faculty, Oncology Hospital

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: CENTRE FRANCOIS BACLESSE; Oncologie- Pneumologie

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Florida Cancer Specialists; Department of Oncology

location_facility: Ege University Medical Faculty; Medical Oncology Department

location_facility: Seoul National University Bundang Hospital

location_facility: China Medical University Hospital; Pulmonary and Critical Care Medicine

location_facility: Sir Run Run Shaw Hospital Zhejiang University

location_facility: Texas Oncology-El Paso Cancer Treatment Center Grandview

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Ramathibodi Hospital; Medicine/Oncology; Clinical Research Center

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Tennessee Oncology; Sarah Cannon Research Institute

location_facility: Monash Health Translational Precinct; Clinical Trials Centre, Level 3

location_facility: Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

location_facility: Xiangya Hospital Central South University

location_facility: Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials

location_facility: ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii;Wojska Polskiego 37

location_facility: Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii; Oddz. Onkologii Klin. i Chemioterapii

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: William Osler Health System Brampton Civic Hospital

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: Institut Gustave Roussy; Pathologie Thoracique

location_facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili; U.O. Radioterapia

location_facility: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: Changzhou Tumor Hospital, Changzhou Fourth People's Hospital

summary: The purpose of this study is to evaluate the efficacy and safety of atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic disease progression.


title: A Randomized, Multicenter, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease

lead_sponsor: Sanofi

ReferenceCitation: Bardia A, Cortes J, Hurvitz SA, Delaloge S, Iwata H, Shao ZM, Kanagavel D, Cohen P, Liu Q, Cartot-Cotton S, Pelekanou V, O'Shaughnessy J. AMEERA-5: a randomized, double-blind phase 3 study of amcenestrant plus palbociclib versus letrozole plus palbociclib for previously untreated ER+/HER2- advanced breast cancer. Ther Adv Med Oncol. 2022 Mar 15;14:17588359221083956. doi: 10.1177/17588359221083956. eCollection 2022.

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

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Turkey
Singapore
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Georgia
Estonia
Finland
Korea, Republic of
France
Chile
Netherlands

location_facility:
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Investigational Site Number :8400072
Investigational Site Number :1560049
Investigational Site Number :2030003
Investigational Site Number :1240005
Investigational Site Number :0360005
Investigational Site Number :1560053
Investigational Site Number :5280001
Investigational Site Number :3800001
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Investigational Site Number :8400010
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Investigational Site Number :7920006
Investigational Site Number :3920022
Investigational Site Number :1520005
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Investigational Site Number :3480001
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Investigational Site Number :0320004
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Investigational Site Number :2500002
Investigational Site Number :1000005
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Investigational Site Number :8400016
Investigational Site Number :6430010
Investigational Site Number :1580004
Investigational Site Number :0360003
Investigational Site Number :8400044
Investigational Site Number :8400023
Investigational Site Number :3480008
Investigational Site Number :2680007
Investigational Site Number :3800008
Investigational Site Number :3920015
Investigational Site Number :4100006
Investigational Site Number :6160006
Investigational Site Number :2760006
Investigational Site Number :3920019
Investigational Site Number :4100007
Investigational Site Number :7920007
Investigational Site Number :1000004
Investigational Site Number :6200005
Investigational Site Number :6430006
Investigational Site Number :8400040
Investigational Site Number :6200002
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Investigational Site Number :3920013
Investigational Site Number :6430007
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Investigational Site Number :8400055
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Investigational Site Number :3800005
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Investigational Site Number :6160004
Investigational Site Number :0760008
Investigational Site Number :2680002
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Investigational Site Number :0760005
Investigational Site Number :5280006
Investigational Site Number :6430001
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Investigational Site Number :1560003
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Investigational Site Number :1560006
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Investigational Site Number :2030002
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Investigational Site Number :1580003
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Investigational Site Number :6160002
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Investigational Site Number :1240007
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Investigational Site Number :3920018
Investigational Site Number :7020003
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Investigational Site Number :6430004
Investigational Site Number :1520001
Investigational Site Number :7240009
Investigational Site Number :2680005
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Investigational Site Number :1560005
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Investigational Site Number :3920014
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Investigational Site Number :7020001
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Investigational Site Number :0760003
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Investigational Site Number :1580002
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Investigational Site Number :0320003
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Investigational Site Number :7020002
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Investigational Site Number :1560007
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Investigational Site Number :3480003
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Investigational Site Number :1580001
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summary:
Primary Objective:

To determine whether Amcenestrant (SAR439859) in combination with palbociclib improvesprogression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with ER+, HER2- advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease.

Secondary Objective:

To compare the overall survival in both treatment arms
To evaluate the objective response rate in both treatment arms
To evaluate the duration of response in both treatment arms
To evaluate the clinical benefit rate in both treatment arms
To evaluate progression-free survival on next line of therapy
To evaluate the pharmacokinetics of amcenestrant, and palbociclib
To evaluate health-related quality of life in both treatment arms
To evaluate the time to first chemotherapy in both treatment arms
To evaluate safety in both treatment arms


acronym: ADjoin

title: A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis (ADjoin)

lead_sponsor: Eli Lilly and Company

design_allocation: Non-Randomized

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:
Poland
Taiwan
Spain
Latvia
Estonia
Australia
Canada
Lithuania
Ukraine
Korea, Republic of
United States
France
Singapore
Mexico
Germany
Bulgaria

location_facility: Praxis Dr. med. Virgil-Oreste Mihaescu Facharzt fr Dermatologie und STD

location_facility: Private Practice - Dr. Ralph von Kiedrowski

location_facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.

location_facility: California Dermatology & Clinical Research Institute

location_facility: Laser Clinic Dermatologia Laserowa Medycyna Estetyczna

location_facility: Municipal Healthcare Institution Kharkiv City Dermatoverenologic Dispensary N2

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos

location_facility: Dermatology Treatment and Research Center

location_facility: Northwest Arkansas Clinical Trials Center

location_facility: Skin Laser and Surgery Specialists, a Division of Schweiger Dermatology

location_facility: Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak

location_facility: University Hospitals Case Medical Center

location_facility: Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o.

location_facility: George Washington University Medical Center

location_facility: Simcoderm Medical & Surgical Dermatology Centre

location_facility: Rivne Regional Dermatology and Venereology Dispensary

location_facility: Health Center 4, Affiliate Diagnostic Center

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Riverchase Dermatology and Cosmetic Surgery

location_facility: California Allergy and Asthma Medical Group + Research Center

location_facility: Ablon Skin Institute and Research Center

location_facility: Dermatology and Skin Cancer Specialists, LLC

location_facility: Bakersfield Dermatology and Skin Cancer Medical Group

location_facility: Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk

location_facility: Praxis für Ganzheitliche Dermatologie im Ärztehaus

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Universität Leipzig - Universitätsklinikum

location_facility: Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"

location_facility: Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik und Poliklinik fuer

location_facility: Keck School of Medicine University of Southern California

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: JSC "Center for Diagnosis and Treatment of Allergic Diseases"

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital General Universitario de Alicante

location_facility: Clinical Research Center of Alabama- Birmingham

location_facility: Center For Dermatology Clinical Research, Inc.

location_facility: Vital Prospects Clinical Research Institute, PC

location_facility: Clinical Research Center of the Carolinas

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Psoriasis Treatment Center of Central New Jersey

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie

location_facility: University of the Sunshine Coast Clinical Trial Centre

location_facility: Georgia Pollens Clinical Research Centers, Inc

location_facility: Smite Aija - Doctor Practice in Dermatology Venereology

location_facility: SE "Institute of Dermatology and Venerology of NAMS of Ukraine"

location_facility: Florida Academic Centers Research and Education, LLC

location_facility: The Pennsylvania Centre for Dermatology, LLC

location_facility: Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology

location_facility: International Dermatology Research, Inc.

location_facility: Community Institution Zaporizhzhya Regional Dermatovenereology Clinical Hospital of Zaporizhzhya Regional Council

location_facility: Rivergate Dermatology Clinical Research Center PL

location_facility: Soon Chun Hyang University Bucheon Hospital

location_facility: Clinica De Enfermedades Cronicas y Procedimientos Especiales

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Children's Hospital, Affiliate of Vilnius University Hospital Santaros klinikos

location_facility: Treatment-diagnostic center PE "Asclepius"

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o.

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

location_facility: Taipei Medical University Shuang Ho Hospital

summary: This 110-week study is designed to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis.