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)

NCT05508867 | Completed Phase 2 DMC FDA Drug

• 5 other identifiers: 4280A-008MK-4280A-0082023-503615-14-00U1111-1287-58642022-000371-39
• Study Type: interventional
• Target: 203
• Locations: 20 countries
• Sites: 105

Brief 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.

Conditions

Hodgkin Lymphoma

Keywords

Programmed Cell Death-1 (PD1, PD-1); Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1); Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) per Lugano Response Criteria as Assessed by investigator

  PFS is defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 as assessed by investigator or death due to any cause, whichever occurs first.

  Up to approximately 39 months

Secondary Outcomes (5)

• Overall Survival (OS)

  Up to approximately 39 months

• Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by investigator

  Up to approximately 39 months

• Duration of Response (DOR) per Lugano Response Criteria as Assessed by investigator

  Up to approximately 39 months

• Number of Participants Who Experienced At Least One Adverse Event (AE)

  Up to approximately 25 months

• Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)

  Up to approximately 24 months

Study Arms (2)

Favezelimab/Pembrolizumab

EXPERIMENTAL

Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions.

Biological: favezelimab/pembrolizumab

Chemotherapy (Bendamustine or Gemcitabine)

ACTIVE COMPARATOR

Participants will receive physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles.

Drug: bendamustine; Drug: gemcitabine

Interventions

bendamustine DRUG

IV infusion

Also known as: BENDEKA®

Chemotherapy (Bendamustine or Gemcitabine)

favezelimab/pembrolizumab BIOLOGICAL

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

Also known as: MK-4820A

Favezelimab/Pembrolizumab

gemcitabine DRUG

IV infusion

Also known as: GEMZAR®

Chemotherapy (Bendamustine or Gemcitabine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) that is 2-fluorodeoxyglucose-avid (FDG-avid).
• Has relapsed (defined as disease progression after most recent therapy) or refractory (defined as failed to achieve CR or PR to most recent therapy) cHL and exhausted all available treatment options with known clinical benefit.
• Has progressed on treatment with an anti-PD-(L)1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
• Submits an archival (≤5 years) or newly obtained tumor tissue sample which has not been previously irradiated.

You may not qualify if:

• Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy.
• History of central nervous system (CNS) metastases or active CNS involvement.
• Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
• History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
• Has an active infection requiring systemic treatment.
• History of hemophagocytic lymphohisticytosis.
• Has an active seizure disorder that is not well controlled.
• Has clinically significant (ie, active) cardiovascular disease.
• Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
• Received prior radiotherapy within 2 weeks of start of study intervention or radiation related toxicities requiring corticosteroids.
• Has not adequately recovered from major surgical procedure.
• Known additional malignancy that is progressing or has required active treatment within the past 3 years.
• History of human immunodeficiency virus (HIV).
• Has had an allogeneic hematopoietic stem cell or solid organ transplantation within the last 5 years.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (105)

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

Tucson, Arizona, 85719, United States

Location

UCLA Hematology/Oncology - Santa Monica ( Site 2208)

Los Angeles, California, 90404, United States

Location

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

Torrance, California, 90502, United States

Location

Moffitt Cancer Center ( Site 2200)

Tampa, Florida, 33612, United States

Location

University of Kentucky Chandler Medical Center ( Site 2201)

Lexington, Kentucky, 40536, United States

Location

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

Baltimore, Maryland, 21201, United States

Location

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

Baltimore, Maryland, 21231, United States

Location

University of Michigan ( Site 2215)

Ann Arbor, Michigan, 48109, United States

Location

Cancer and Hematology Centers of Western Michigan ( Site 2222)

Grand Rapids, Michigan, 49503, United States

Location

Rutgers Cancer Institute of New Jersey ( Site 2217)

New Brunswick, New Jersey, 08903, United States

Location

Roswell Park Cancer Institute ( Site 2220)

Buffalo, New York, 14263, United States

Location

University Hospitals Cleveland Medical Center ( Site 2214)

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic-Taussig Cancer Center ( Site 2203)

Cleveland, Ohio, 44195, United States

Location

AHN West Penn Hospital ( Site 2213)

Pittsburgh, Pennsylvania, 15224, United States

Location

UPMC Hillman Cancer Center ( Site 2205)

Pittsburgh, Pennsylvania, 15232, United States

Location

Fred Hutchinson Cancer Center ( Site 2212)

Seattle, Washington, 98109, United States

Location

Hospital Aleman-oncohematologic diseases ( Site 2302)

Buenos Aires, C1118AAT, Argentina

Location

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

Mendoza, M5500AYB, Argentina

Location

The Townsville Hospital ( Site 0006)

Townsville, Queensland, 4814, Australia

Location

Royal Adelaide Hospital ( Site 0005)

Adelaide, South Australia, 5000, Australia

Location

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

St Albans, Victoria, 3021, Australia

Location

Royal Perth Hospital-Haematology ( Site 0004)

Perth, Western Australia, 6000, Australia

Location

UZ Leuven-Hematology ( Site 0101)

Leuven, Vlaams-Brabant, 3000, Belgium

Location

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

Namur, 5530, Belgium

Location

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

Barretos, São Paulo, 14784400, Brazil

Location

Hospital Paulistano-Americas Oncologia ( Site 0207)

São Paulo, 01321-001, Brazil

Location

Cross Cancer Institute ( Site 0313)

Edmonton, Alberta, T6G 1Z2, Canada

Location

Princess Margaret Cancer Centre ( Site 0310)

Toronto, Ontario, M5G 2M9, Canada

Location

Jewish General Hospital ( Site 0309)

Montreal, Quebec, H3T 1E2, Canada

Location

McGill University Health Centre ( Site 0314)

Montreal, Quebec, H4A 3J1, Canada

Location

FALP-UIDO ( Site 0400)

Santiago, Region M. de Santiago, 7500921, Chile

Location

Clínica Inmunocel ( Site 0407)

Santiago, Region M. de Santiago, 7580206, Chile

Location

Anhui Provincial Cancer Hospital ( Site 0501)

Hefei, Anhui, 230031, China

Location

Beijing Hospital ( Site 0514)

Beijing, Beijing Municipality, 100005, China

Location

Peking University Third Hospital-Hematology ( Site 0519)

Beijing, Beijing Municipality, 100091, China

Location

The First Affiliated hospital of Xiamen University ( Site 0512)

Xiamen, Fujian, 361003, China

Location

Sun Yat-sen University Cancer Center ( Site 0500)

Guangzhou, Guangdong, 510060, China

Location

Henan Cancer Hospital ( Site 0515)

Zhengzhou, Henan, 450008, China

Location

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

Wuhan, Hubei, 430010, China

Location

Xiangya Hospital Central South University ( Site 0513)

Changsha, Hunan, 410008, China

Location

Hunan Cancer Hospital ( Site 0503)

Changsha, Hunan, 410013, China

Location

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

Changchun, Jilin, 130021, China

Location

Fudan University Shanghai Cancer Center ( Site 0520)

Shanghai, Shanghai Municipality, 200032, China

Location

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

Chengdu, Sichuan, 610041, China

Location

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

Tianjin, Tianjin Municipality, 300060, China

Location

Zhejiang Cancer Hospital ( Site 0510)

Hangzhou, Zhejiang, 310022, China

Location

Ningbo First Hospital ( Site 0518)

Ningbo, Zhejiang, 315010, China

Location

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

Brno, Brno-mesto, 625 00, Czechia

Location

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

Hradec Králové, 500 05, Czechia

Location

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

Prague, 128 08, Czechia

Location

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

Rennes, Brittany Region, 35033, France

Location

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

Toulouse, Haute-Garonne, 31059, France

Location

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

Limoges, Haute-Vienne, 87042, France

Location

Institut Curie - site Saint-Cloud ( Site 0708)

Saint-Cloud, Hauts-de-Seine, 92210, France

Location

CENTRE LEON BERARD-Medical oncology ( Site 0703)

Lyon, Rhone, 69008, France

Location

HENRI MONDOR HOSPITAL ( Site 0702)

Créteil, Seine-et-Marne, 94000, France

Location

Klinikum Stuttgart - Katharinenhospital ( Site 0804)

Stuttgart, Baden-Wurttemberg, 70174, Germany

Location

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

Ulm, Baden-Wurttemberg, 89081, Germany

Location

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

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Universitaetsklinikum Essen ( Site 0807)

Essen, North Rhine-Westphalia, 45147, Germany

Location

Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 0806)

Münster, North Rhine-Westphalia, 48149, Germany

Location

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

Dresden, Saxony, 01307, Germany

Location

Universitätsklinikum Leipzig ( Site 0803)

Leipzig, Saxony, 04103, Germany

Location

Rambam Health Care Campus ( Site 1004)

Haifa, 3109601, Israel

Location

Carmel Hospital ( Site 1007)

Haifa, 3436212, Israel

Location

Hadassah Medical Center-Hemato-Oncology ( Site 1000)

Jerusalem, 9112001, Israel

Location

Rabin Medical Center-Hemato-Oncology ( Site 1001)

Petah Tikva, 4910021, Israel

Location

Sheba Medical Center-Hemato Oncology ( Site 1005)

Ramat Gan, 5265601, Israel

Location

Sourasky Medical Center ( Site 1002)

Tel Aviv, 6423906, Israel

Location

Centro de Infusion Superare ( Site 2503)

Mexico City, Mexico City, 03100, Mexico

Location

Unidad Médica Onco-hematológica ( Site 2507)

Puebla City, 72424, Mexico

Location

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

Krakow, Lesser Poland Voivodeship, 31-826, Poland

Location

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

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

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

Gdansk, Pomeranian Voivodeship, 80-214, Poland

Location

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

Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

Location

Pusan National University Hospital-Internal Medicine ( Site 1704)

Busan, Pusan-Kwangyokshi, 49241, South Korea

Location

Seoul National University Hospital ( Site 1701)

Seoul, 03080, South Korea

Location

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

Seoul, 03722, South Korea

Location

Asan Medical Center-Department of Oncology ( Site 1703)

Seoul, 05505, South Korea

Location

Samsung Medical Center ( Site 1700)

Seoul, 06351, South Korea

Location

Hospital Universitario Marqués de Valdecilla ( Site 1805)

Santander, Cantabria, 39008, Spain

Location

Hospital Universitari Vall d'Hebron ( Site 1803)

Barcelona, Catalonia, 08035, Spain

Location

CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 1812)

A Coruña, La Coruna, 15006, Spain

Location

Hospital Insular de Gran Canaria-Oncology ( Site 1807)

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

Hospital General Universitario de Alicante ( Site 1806)

Alicante, 03010, Spain

Location

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

Madrid, 28041, Spain

Location

Hospital Universitario Virgen de la Victoria ( Site 1808)

Málaga, 29010, Spain

Location

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

Salamanca, 37007, Spain

Location

Skånes Universitetssjukhus Lund ( Site 1901)

Lund, Skåne County, 22185, Sweden

Location

Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1900)

Uppsala, Uppsala County, 751 85, Sweden

Location

Ospedale Regionale Bellinzona e Valli-IOSI ( Site 1600)

Bellinzona, Canton Ticino, 6501, Switzerland

Location

Mega Medipol-Hematology ( Site 2005)

Stanbul, Istanbul, 34214, Turkey (Türkiye)

Location

Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 2000)

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe Universite Hastaneleri-Department of Hematology ( Site 2006)

Ankara, 06230, Turkey (Türkiye)

Location

Antalya Egitim ve Arastırma Hastanesi ( Site 2011)

Antalya, 07100, Turkey (Türkiye)

Location

Ege Universitesi Hastanesi ( Site 2001)

Izmir, 35100, Turkey (Türkiye)

Location

Kocaeli Üniversitesi-Hematology ( Site 2009)

Kocaeli, 41380, Turkey (Türkiye)

Location

Derriford Hospital ( Site 2107)

Plymouth, Devon, Pl6 8DH, United Kingdom

Location

The Beatson West of Scotland Cancer Centre ( Site 2110)

Glasgow, Glasgow City, G12 0YN, United Kingdom

Location

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

London, London, City of, EC1A 7BE, United Kingdom

Location

GenesisCare - Oxford ( Site 2104)

Oxford, Oxfordshire, OX4 6LB, United Kingdom

Location

St James's University Hospital ( Site 2109)

Leeds, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary ( Site 2100)

Leicester, LE1 5WW, United Kingdom

Location

Clatterbridge Cancer Centre - Liverpool-Heamatology ( Site 2108)

Liverpool, L7 8YA, United Kingdom

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Hodgkin Disease; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; Bendamustine Hydrochloride; Gemcitabine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 19, 2022
• Study Start: October 18, 2022
• Primary Completion: September 3, 2025
• Study Completion: January 8, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (16); CL (2); DE (7); CN (15); CZ (3); KR (5); BE (2); SE (2); PL (5); ES (8); GB (7); CH (1); TU (6); IL (6); BR (2); FR (6); AU (4); AR (2); CA (4); ME (2)