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COMPLETED
NCT05508867
PHASE2

A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

Researchers are looking for a way to treat classical Hodgkin lymphoma (cHL) that is relapsed (the cancer has come back after treatment) or refractory (current treatment has stopped working to slow or stop cancer growth). Researchers want to learn if people who receive coformulated favezelimab/pembrolizumab (MK-4280A) live longer without the cancer getting worse compared to those who receive chemotherapy.

Official title: A Phase 2 Randomized Clinical Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (KEYFORM-008)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

203

Start Date

2022-10-18

Completion Date

2026-01-08

Last Updated

2026-09-01

Healthy Volunteers

No

Interventions

BIOLOGICAL

favezelimab/pembrolizumab

Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion

DRUG

bendamustine

IV infusion

DRUG

gemcitabine

IV infusion

Locations (105)

The University of Arizona Cancer Center - North Campus ( Site 2216)

Tucson, Arizona, United States

UCLA Hematology/Oncology - Santa Monica ( Site 2208)

Los Angeles, California, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site

Torrance, California, United States

Moffitt Cancer Center ( Site 2200)

Tampa, Florida, United States

University of Kentucky Chandler Medical Center ( Site 2201)

Lexington, Kentucky, United States

University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 2210)

Baltimore, Maryland, United States

Johns Hopkins University-The Sidney Kimmel Comprehensive Cancer Center ( Site 2206)

Baltimore, Maryland, United States

University of Michigan ( Site 2215)

Ann Arbor, Michigan, United States

Cancer and Hematology Centers of Western Michigan ( Site 2222)

Grand Rapids, Michigan, United States

Rutgers Cancer Institute of New Jersey ( Site 2217)

New Brunswick, New Jersey, United States

Roswell Park Cancer Institute ( Site 2220)

Buffalo, New York, United States

University Hospitals Cleveland Medical Center ( Site 2214)

Cleveland, Ohio, United States

Cleveland Clinic-Taussig Cancer Center ( Site 2203)

Cleveland, Ohio, United States

AHN West Penn Hospital ( Site 2213)

Pittsburgh, Pennsylvania, United States

UPMC Hillman Cancer Center ( Site 2205)

Pittsburgh, Pennsylvania, United States

Fred Hutchinson Cancer Center ( Site 2212)

Seattle, Washington, United States

Hospital Aleman-oncohematologic diseases ( Site 2302)

Buenos Aires, Argentina

Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 2301)

Mendoza, Argentina

The Townsville Hospital ( Site 0006)

Townsville, Queensland, Australia

Royal Adelaide Hospital ( Site 0005)

Adelaide, South Australia, Australia

Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0002)

St Albans, Victoria, Australia

Royal Perth Hospital-Haematology ( Site 0004)

Perth, Western Australia, Australia

UZ Leuven-Hematology ( Site 0101)

Leuven, Vlaams-Brabant, Belgium

Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi

Namur, Belgium

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0202)

Barretos, São Paulo, Brazil

Hospital Paulistano-Americas Oncologia ( Site 0207)

São Paulo, Brazil

Cross Cancer Institute ( Site 0313)

Edmonton, Alberta, Canada

Princess Margaret Cancer Centre ( Site 0310)

Toronto, Ontario, Canada

Jewish General Hospital ( Site 0309)

Montreal, Quebec, Canada

McGill University Health Centre ( Site 0314)

Montreal, Quebec, Canada

FALP-UIDO ( Site 0400)

Santiago, Region M. de Santiago, Chile

Clínica Inmunocel ( Site 0407)

Santiago, Region M. de Santiago, Chile

Anhui Provincial Cancer Hospital ( Site 0501)

Hefei, Anhui, China

Beijing Hospital ( Site 0514)

Beijing, Beijing Municipality, China

Peking University Third Hospital-Hematology ( Site 0519)

Beijing, Beijing Municipality, China

The First Affiliated hospital of Xiamen University ( Site 0512)

Xiamen, Fujian, China

Sun Yat-sen University Cancer Center ( Site 0500)

Guangzhou, Guangdong, China

Henan Cancer Hospital ( Site 0515)

Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0509)

Wuhan, Hubei, China

Xiangya Hospital Central South University ( Site 0513)

Changsha, Hunan, China

Hunan Cancer Hospital ( Site 0503)

Changsha, Hunan, China

The First Hospital of Jilin University-Hematology ( Site 0516)

Changchun, Jilin, China

Fudan University Shanghai Cancer Center ( Site 0520)

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University-Head and Neck Oncology ( Site 0502)

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 0506)

Tianjin, Tianjin Municipality, China

Zhejiang Cancer Hospital ( Site 0510)

Hangzhou, Zhejiang, China

Ningbo First Hospital ( Site 0518)

Ningbo, Zhejiang, China

Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0901)

Brno, Brno-mesto, Czechia

Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0902)

Hradec Králové, Czechia

Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0903)

Prague, Czechia

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou-haematology ( Site 0707)

Rennes, Brittany Region, France

Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0706)

Toulouse, Haute-Garonne, France

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0704)

Limoges, Haute-Vienne, France

Institut Curie - site Saint-Cloud ( Site 0708)

Saint-Cloud, Hauts-de-Seine, France

CENTRE LEON BERARD-Medical oncology ( Site 0703)

Lyon, Rhone, France

HENRI MONDOR HOSPITAL ( Site 0702)

Créteil, Seine-et-Marne, France

Klinikum Stuttgart - Katharinenhospital ( Site 0804)

Stuttgart, Baden-Wurttemberg, Germany

Universitaetsklinikum Ulm-Department of Internal Medicine III ( Site 0805)

Ulm, Baden-Wurttemberg, Germany

Universitaetsklinikum Koeln-Klinik I für Innere Medizin ( Site 0801)

Cologne, North Rhine-Westphalia, Germany

Universitaetsklinikum Essen ( Site 0807)

Essen, North Rhine-Westphalia, Germany

Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 0806)

Münster, North Rhine-Westphalia, Germany

Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit (

Dresden, Saxony, Germany

Universitätsklinikum Leipzig ( Site 0803)

Leipzig, Saxony, Germany

Rambam Health Care Campus ( Site 1004)

Haifa, Israel

Carmel Hospital ( Site 1007)

Haifa, Israel

Hadassah Medical Center-Hemato-Oncology ( Site 1000)

Jerusalem, Israel

Rabin Medical Center-Hemato-Oncology ( Site 1001)

Petah Tikva, Israel

Sheba Medical Center-Hemato Oncology ( Site 1005)

Ramat Gan, Israel

Sourasky Medical Center ( Site 1002)

Tel Aviv, Israel

Centro de Infusion Superare ( Site 2503)

Mexico City, Mexico City, Mexico

Unidad Médica Onco-hematológica ( Site 2507)

Puebla City, Mexico

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1406)

Krakow, Lesser Poland Voivodeship, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Hematologii, Nowotworów Krwi i

Wroclaw, Lower Silesian Voivodeship, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site

Warsaw, Masovian Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1402)

Gdansk, Pomeranian Voivodeship, Poland

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S

Kielce, Świętokrzyskie Voivodeship, Poland

Pusan National University Hospital-Internal Medicine ( Site 1704)

Busan, Pusan-Kwangyokshi, South Korea

Seoul National University Hospital ( Site 1701)

Seoul, South Korea

Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1702)

Seoul, South Korea

Asan Medical Center-Department of Oncology ( Site 1703)

Seoul, South Korea

Samsung Medical Center ( Site 1700)

Seoul, South Korea

Hospital Universitario Marqués de Valdecilla ( Site 1805)

Santander, Cantabria, Spain

Hospital Universitari Vall d'Hebron ( Site 1803)

Barcelona, Catalonia, Spain

CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 1812)

A Coruña, La Coruna, Spain

Hospital Insular de Gran Canaria-Oncology ( Site 1807)

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital General Universitario de Alicante ( Site 1806)

Alicante, Spain

Hospital Universitario 12 de Octubre-Hemathology and hemotherapy ( Site 1810)

Madrid, Spain

Hospital Universitario Virgen de la Victoria ( Site 1808)

Málaga, Spain

Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1801)

Salamanca, Spain

Skånes Universitetssjukhus Lund ( Site 1901)

Lund, Skåne County, Sweden

Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1900)

Uppsala, Uppsala County, Sweden

Ospedale Regionale Bellinzona e Valli-IOSI ( Site 1600)

Bellinzona, Canton Ticino, Switzerland

Mega Medipol-Hematology ( Site 2005)

Stanbul, Istanbul, Turkey (Türkiye)

Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 2000)

Ankara, Turkey (Türkiye)

Hacettepe Universite Hastaneleri-Department of Hematology ( Site 2006)

Ankara, Turkey (Türkiye)

Antalya Egitim ve Arastırma Hastanesi ( Site 2011)

Antalya, Turkey (Türkiye)

Ege Universitesi Hastanesi ( Site 2001)

Izmir, Turkey (Türkiye)

Kocaeli Üniversitesi-Hematology ( Site 2009)

Kocaeli, Turkey (Türkiye)

Derriford Hospital ( Site 2107)

Plymouth, Devon, United Kingdom

The Beatson West of Scotland Cancer Centre ( Site 2110)

Glasgow, Glasgow City, United Kingdom

St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2105)

London, London, City of, United Kingdom

GenesisCare - Oxford ( Site 2104)

Oxford, Oxfordshire, United Kingdom

St James's University Hospital ( Site 2109)

Leeds, United Kingdom

Leicester Royal Infirmary ( Site 2100)

Leicester, United Kingdom

Clatterbridge Cancer Centre - Liverpool-Heamatology ( Site 2108)

Liverpool, United Kingdom