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Hodgkin LymphomaPhase 2NCT05508867

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)

A Phase 2 study testing favezelimab/pembrolizumab, bendamustine and gemcitabine in people with Hodgkin Lymphoma, run by Merck Sharp & Dohme LLC at 105 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
favezelimab/pembrolizumab, bendamustine and gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
105 sitesin 20 countries
Study dates
18 Oct 2022to 8 Jan 2026
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

105 sites in 20 countries.

105 sites in 20 countries

United States16 sites

  • University of Michigan ( Site 2215)

    Ann Arbor, Michigan, 48109

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

    Baltimore, Maryland, 21201

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

    Baltimore, Maryland, 21231

  • Roswell Park Cancer Institute ( Site 2220)

    Buffalo, New York, 14263

  • University Hospitals Cleveland Medical Center ( Site 2214)

    Cleveland, Ohio, 44106

  • Cleveland Clinic-Taussig Cancer Center ( Site 2203)

    Cleveland, Ohio, 44195

  • Cancer and Hematology Centers of Western Michigan ( Site 2222)

    Grand Rapids, Michigan, 49503

  • University of Kentucky Chandler Medical Center ( Site 2201)

    Lexington, Kentucky, 40536

  • UCLA Hematology/Oncology - Santa Monica ( Site 2208)

    Los Angeles, California, 90404

  • Rutgers Cancer Institute of New Jersey ( Site 2217)

    New Brunswick, New Jersey, 08903

  • AHN West Penn Hospital ( Site 2213)

    Pittsburgh, Pennsylvania, 15224

  • UPMC Hillman Cancer Center ( Site 2205)

    Pittsburgh, Pennsylvania, 15232

  • Fred Hutchinson Cancer Center ( Site 2212)

    Seattle, Washington, 98109

  • Moffitt Cancer Center ( Site 2200)

    Tampa, Florida, 33612

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

    Torrance, California, 90502

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

    Tucson, Arizona, 85719

Other trials in United States

China15 sites

  • Beijing Hospital ( Site 0514)

    Beijing, Beijing Municipality, 100005

  • Peking University Third Hospital-Hematology ( Site 0519)

    Beijing, Beijing Municipality, 100091

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

    Changchun, Jilin, 130021

  • Xiangya Hospital Central South University ( Site 0513)

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital ( Site 0503)

    Changsha, Hunan, 410013

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

    Chengdu, Sichuan, 610041

  • Sun Yat-sen University Cancer Center ( Site 0500)

    Guangzhou, Guangdong, 510060

  • Zhejiang Cancer Hospital ( Site 0510)

    Hangzhou, Zhejiang, 310022

  • Anhui Provincial Cancer Hospital ( Site 0501)

    Hefei, Anhui, 230031

  • Ningbo First Hospital ( Site 0518)

    Ningbo, Zhejiang, 315010

  • Fudan University Shanghai Cancer Center ( Site 0520)

    Shanghai, Shanghai Municipality, 200032

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

    Tianjin, Tianjin Municipality, 300060

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

    Wuhan, Hubei, 430010

  • The First Affiliated hospital of Xiamen University ( Site 0512)

    Xiamen, Fujian, 361003

  • Henan Cancer Hospital ( Site 0515)

    Zhengzhou, Henan, 450008

Other trials in China

Spain8 sites

  • CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 1812)

    A Coruña, La Coruna, 15006

  • Hospital General Universitario de Alicante ( Site 1806)

    Alicante, 03010

  • Hospital Universitari Vall d'Hebron ( Site 1803)

    Barcelona, Catalonia, 08035

  • Hospital Insular de Gran Canaria-Oncology ( Site 1807)

    Las Palmas de Gran Canaria, Las Palmas, 35016

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

    Madrid, 28041

  • Hospital Universitario Virgen de la Victoria ( Site 1808)

    Málaga, 29010

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

    Salamanca, 37007

  • Hospital Universitario Marqués de Valdecilla ( Site 1805)

    Santander, Cantabria, 39008

Other trials in Spain

Germany7 sites

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

    Cologne, North Rhine-Westphalia, 50937

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

    Dresden, Saxony, 01307

  • Universitaetsklinikum Essen ( Site 0807)

    Essen, North Rhine-Westphalia, 45147

  • Universitätsklinikum Leipzig ( Site 0803)

    Leipzig, Saxony, 04103

  • Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 0806)

    Münster, North Rhine-Westphalia, 48149

  • Klinikum Stuttgart - Katharinenhospital ( Site 0804)

    Stuttgart, Baden-Wurttemberg, 70174

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

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

United Kingdom7 sites

  • The Beatson West of Scotland Cancer Centre ( Site 2110)

    Glasgow, Glasgow City, G12 0YN

  • St James's University Hospital ( Site 2109)

    Leeds, LS9 7TF

  • Leicester Royal Infirmary ( Site 2100)

    Leicester, LE1 5WW

  • Clatterbridge Cancer Centre - Liverpool-Heamatology ( Site 2108)

    Liverpool, L7 8YA

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

    London, London, City of, EC1A 7BE

  • GenesisCare - Oxford ( Site 2104)

    Oxford, Oxfordshire, OX4 6LB

  • Derriford Hospital ( Site 2107)

    Plymouth, Devon, Pl6 8DH

Other trials in United Kingdom

France6 sites

  • HENRI MONDOR HOSPITAL ( Site 0702)

    Créteil, Seine-et-Marne, 94000

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

    Limoges, Haute-Vienne, 87042

  • CENTRE LEON BERARD-Medical oncology ( Site 0703)

    Lyon, Rhone, 69008

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

    Rennes, Brittany Region, 35033

  • Institut Curie - site Saint-Cloud ( Site 0708)

    Saint-Cloud, Hauts-de-Seine, 92210

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

    Toulouse, Haute-Garonne, 31059

Other trials in France

Israel6 sites

  • Rambam Health Care Campus ( Site 1004)

    Haifa, 3109601

  • Carmel Hospital ( Site 1007)

    Haifa, 3436212

  • Hadassah Medical Center-Hemato-Oncology ( Site 1000)

    Jerusalem, 9112001

  • Rabin Medical Center-Hemato-Oncology ( Site 1001)

    Petah Tikva, 4910021

  • Sheba Medical Center-Hemato Oncology ( Site 1005)

    Ramat Gan, 5265601

  • Sourasky Medical Center ( Site 1002)

    Tel Aviv, 6423906

Other trials in Israel

Turkey (Türkiye)6 sites

  • Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 2000)

    Ankara, 06100

  • Hacettepe Universite Hastaneleri-Department of Hematology ( Site 2006)

    Ankara, 06230

  • Antalya Egitim ve Arastırma Hastanesi ( Site 2011)

    Antalya, 07100

  • Ege Universitesi Hastanesi ( Site 2001)

    Izmir, 35100

  • Kocaeli Üniversitesi-Hematology ( Site 2009)

    Kocaeli, 41380

  • Mega Medipol-Hematology ( Site 2005)

    Stanbul, Istanbul, 34214

Other trials in Turkey (Türkiye)

Poland5 sites

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

    Gdansk, Pomeranian Voivodeship, 80-214

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

    Kielce, Świętokrzyskie Voivodeship, 25-734

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

    Krakow, Lesser Poland Voivodeship, 31-826

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

    Warsaw, Masovian Voivodeship, 02-781

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

    Wroclaw, Lower Silesian Voivodeship, 50-556

Other trials in Poland

South Korea5 sites

  • Pusan National University Hospital-Internal Medicine ( Site 1704)

    Busan, Pusan-Kwangyokshi, 49241

  • Seoul National University Hospital ( Site 1701)

    Seoul, 03080

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

    Seoul, 03722

  • Asan Medical Center-Department of Oncology ( Site 1703)

    Seoul, 05505

  • Samsung Medical Center ( Site 1700)

    Seoul, 06351

Other trials in South Korea

Australia4 sites

  • Royal Adelaide Hospital ( Site 0005)

    Adelaide, South Australia, 5000

  • Royal Perth Hospital-Haematology ( Site 0004)

    Perth, Western Australia, 6000

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

    St Albans, Victoria, 3021

  • The Townsville Hospital ( Site 0006)

    Townsville, Queensland, 4814

Other trials in Australia

Canada4 sites

  • Cross Cancer Institute ( Site 0313)

    Edmonton, Alberta, T6G 1Z2

  • Jewish General Hospital ( Site 0309)

    Montreal, Quebec, H3T 1E2

  • McGill University Health Centre ( Site 0314)

    Montreal, Quebec, H4A 3J1

  • Princess Margaret Cancer Centre ( Site 0310)

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Czechia3 sites

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

    Brno, Brno-mesto, 625 00

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

    Hradec Králové, 500 05

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

    Prague, 128 08

Other trials in Czechia

Argentina2 sites

  • Hospital Aleman-oncohematologic diseases ( Site 2302)

    Buenos Aires, C1118AAT

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

    Mendoza, M5500AYB

Other trials in Argentina

Belgium2 sites

  • UZ Leuven-Hematology ( Site 0101)

    Leuven, Vlaams-Brabant, 3000

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

    Namur, 5530

Other trials in Belgium

Brazil2 sites

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

    Barretos, São Paulo, 14784400

  • Hospital Paulistano-Americas Oncologia ( Site 0207)

    São Paulo, 01321-001

Other trials in Brazil

Chile2 sites

  • FALP-UIDO ( Site 0400)

    Santiago, Region M. de Santiago, 7500921

  • Clínica Inmunocel ( Site 0407)

    Santiago, Region M. de Santiago, 7580206

Other trials in Chile

Mexico2 sites

  • Centro de Infusion Superare ( Site 2503)

    Mexico City, Mexico City, 03100

  • Unidad Médica Onco-hematológica ( Site 2507)

    Puebla City, 72424

Other trials in Mexico

Sweden2 sites

  • Skånes Universitetssjukhus Lund ( Site 1901)

    Lund, Skåne County, 22185

  • Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1900)

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

Switzerland1 site

  • Ospedale Regionale Bellinzona e Valli-IOSI ( Site 1600)

    Bellinzona, Canton Ticino, 6501

Other trials in Switzerland

About this study

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)

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.

Being tested
favezelimab/pembrolizumab, bendamustine, gemcitabine
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)
Medical subject headings
Hodgkin Disease, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • favezelimab/pembrolizumabBiological

    Also called MK-4820A

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

  • bendamustineDrug

    Also called BENDEKA®

    IV infusion

  • gemcitabineDrug

    Also called GEMZAR®

    IV infusion

Study groups in NCT05508867
Study groupRoleWhat they receive
Favezelimab/PembrolizumabExperimentalParticipants 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.
Receives: Biological: favezelimab/pembrolizumab
Chemotherapy (Bendamustine or Gemcitabine)Active comparatorParticipants 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.
Receives: Drug: bendamustine; Drug: gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) Per Lugano Response Criteria as Assessed by Investigator

    PFS was 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 occurred first. Progressive disease was defined as uptake moderately or markedly higher than the liver with an increase in overall uptake compared with nadir, and/or the appearance of new lesions consistent with lymphoma.

    Measured: Up to approximately 34 months

Secondary outcomes (5)

  1. Overall Survival (OS)

    OS was defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 34 months

  2. Objective Response Rate (ORR) Per Lugano Response Criteria as Assessed by Investigator

    ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) per Lugano criteria 2014 as assessed by investigator. CR or PR were evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose-positron emission tomography (FDG-PET)). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal).

    Measured: Up to approximately 34 months

  3. Duration of Response (DOR) Per Lugano Response Criteria as Assessed by Investigator

    For participants who demonstrated CR or PR per Lugano criteria 2014 as assessed by investigator, DOR was defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. CR or PR were evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose-positron emission tomography (FDG-PET)). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal).

    Measured: Up to approximately 34 months

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

    An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced an AE is presented.

    Measured: Up to approximately 28 months

  5. Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE is presented.

    Measured: Up to approximately 28 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2022
  2. Study start18 Oct 2022
  3. Primary completion3 Sep 2025
  4. Study completion8 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05508867
Sponsor's protocol ID
4280A-008
Other IDs
MK-4280A-008, 2023-503615-14-00, U1111-1287-5864, 2022-000371-39, 2023
Status last verified
Aug 2026
First submitted
18 Aug 2022
Last updated
1 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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