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NCT05508867CompletedPhase 2

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 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)

Source: ClinicalTrials.gov · Last updated 1 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
203 (actual)
First submitted
18 Aug 2022
Start date
18 Oct 2022
Primary completion date
3 Sept 2025
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT05508867
EU CT number
2023-503615-14-00
EudraCT number
2022-000371-39

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 203
  • From 18 Oct 2022 to the primary completion date, 3 Sept 2025
  • 106 sites in 20 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy.
  • 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.
  • Has had an allogeneic hematopoietic stem cell or solid organ transplantation within the last 5 years.

Other illness

  • 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.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • History of human immunodeficiency virus (HIV).

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (106)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Aleman-oncohematologic diseases ( Site 2302)
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 2301)
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MendozaArgentinaUnknown status
Royal Adelaide Hospital ( Site 0005)
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AdelaideAustraliaUnknown status
Royal Perth Hospital-Haematology ( Site 0004)
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PerthAustraliaUnknown status
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0002)
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St AlbansAustraliaUnknown status
The Townsville Hospital ( Site 0006)
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TownsvilleAustraliaUnknown status
UZ Leuven
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LeuvenBelgiumCompleted
Chu Ucl Namur
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YvoirBelgiumCompleted
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0202)
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BarretosBrazilUnknown status
Hospital Paulistano-Americas Oncologia ( Site 0207)
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São PauloBrazilUnknown status
Cross Cancer Institute ( Site 0313)
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EdmontonCanadaUnknown status
McGill University Health Centre ( Site 0314)
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MontrealCanadaUnknown status
Jewish General Hospital ( Site 0309)
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MontrealCanadaUnknown status
Princess Margaret Cancer Centre ( Site 0310)
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TorontoCanadaUnknown status
Ospedale Regionale Bellinzona e Valli-IOSI ( Site 1600)
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BellinzonaSwitzerlandUnknown status
Clínica Inmunocel ( Site 0407)
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SantiagoChileUnknown status
FALP-UIDO ( Site 0400)
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SantiagoChileUnknown status
Beijing Hospital ( Site 0514)
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BeijingChinaUnknown status
Peking University Third Hospital-Hematology ( Site 0519)
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BeijingChinaUnknown status
The First Hospital of Jilin University-Hematology ( Site 0516)
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ChangchunChinaUnknown status
Hunan Cancer Hospital ( Site 0503)
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ChangshaChinaUnknown status
Xiangya Hospital Central South University ( Site 0513)
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ChangshaChinaUnknown status
West China Hospital of Sichuan University-Head and Neck Oncology ( Site 0502)
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ChengduChinaUnknown status
Sun Yat-sen University Cancer Center ( Site 0500)
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GuangzhouChinaUnknown status
Zhejiang Cancer Hospital ( Site 0510)
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HangzhouChinaUnknown status
Anhui Provincial Cancer Hospital ( Site 0501)
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HefeiChinaUnknown status
Ningbo First Hospital ( Site 0518)
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NingboChinaUnknown status
Fudan University Shanghai Cancer Center ( Site 0520)
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ShanghaiChinaUnknown status
Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 0506)
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TianjinChinaUnknown status
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0509)
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WuhanChinaUnknown status
The First Affiliated hospital of Xiamen University ( Site 0512)
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XiamenChinaUnknown status
Henan Cancer Hospital ( Site 0515)
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ZhengzhouChinaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaCompleted
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaCompleted
Vseobecna Fakultni Nemocnice V Praze
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Prague 2CzechiaCompleted
University Hospital Cologne AöR
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CologneGermanyCompleted
Technische Universität Dresden
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DresdenGermanyCompleted
Universitaet Leipzig
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LeipzigGermanyCompleted
Westfaelische Wilhelms-Universitaet Muenster
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MuensterGermanyCompleted
Klinikum Der Landeshauptstadt Stuttgart gKAöR
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StuttgartGermanyCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Hospital General Universitario Dr. Balmis
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AlicanteSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Complejo Hospitalario Universitario Insular Materno Infantil
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Las Palmas de Gran CanariaSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
Hospital Universitario De Salamanca
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SalamancaSpainCompleted
Hospital Universitario Marqués de Valdecilla
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SantanderSpainCompleted
Assistance Publique Hopitaux De Paris
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CreteilFranceCompleted
Centre Hospitalier Universitaire de Limoges
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LimogesFranceCompleted
Centre Leon Berard
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LyonFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Centre Hospitalier Universitaire de Rennes
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RennesFranceCompleted
Institut Universitaire Du Cancer Toulouse-Oncopole
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Toulouse Cedex 9FranceCompleted
The Beatson West of Scotland Cancer Centre ( Site 2110)
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GlasgowUnited KingdomUnknown status
St James's University Hospital ( Site 2109)
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LeedsUnited KingdomUnknown status
Leicester Royal Infirmary ( Site 2100)
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LeicesterUnited KingdomUnknown status
Clatterbridge Cancer Centre - Liverpool-Heamatology ( Site 2108)
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LiverpoolUnited KingdomUnknown status
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2105)
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LondonUnited KingdomUnknown status
GenesisCare - Oxford ( Site 2104)
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OxfordUnited KingdomUnknown status
Derriford Hospital ( Site 2107)
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PlymouthUnited KingdomUnknown status
Carmel Hospital ( Site 1007)
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HaifaIsraelUnknown status
Rambam Health Care Campus ( Site 1004)
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HaifaIsraelUnknown status
Hadassah Medical Center-Hemato-Oncology ( Site 1000)
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JerusalemIsraelUnknown status
Rabin Medical Center-Hemato-Oncology ( Site 1001)
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Petah TikvaIsraelUnknown status
Sheba Medical Center-Hemato Oncology ( Site 1005)
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Ramat GanIsraelUnknown status
Sourasky Medical Center ( Site 1002)
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Tel AvivIsraelUnknown status
Pusan National University Hospital-Internal Medicine ( Site 1704)
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BusanSouth KoreaUnknown status
Seoul National University Hospital ( Site 1701)
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SeoulSouth KoreaUnknown status
Samsung Medical Center ( Site 1700)
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SeoulSouth KoreaUnknown status
Asan Medical Center-Department of Oncology ( Site 1703)
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1702)
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SeoulSouth KoreaUnknown status
Centro de Infusion Superare ( Site 2503)
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Mexico CityMexicoUnknown status
Unidad Médica Onco-hematológica ( Site 2507)
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Puebla CityMexicoUnknown status
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
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CracowPolandCompleted
Uniwersyteckie Centrum Kliniczne
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GdanskPolandCompleted
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach
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KielcePolandCompleted
Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w Olsztynie
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OlsztynPolandCompleted
Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W Szczecinie
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SzczecinPolandCompleted
MTZ Clinical Research powered by Pratia
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WarsawPolandCompleted
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandCompleted
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandCompleted
Region Skane Skanes Universitetssjukhus
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LundSwedenCompleted
Uppsala University Hospital
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UppsalaSwedenCompleted
University of Michigan ( Site 2215)
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Ann ArborUnited StatesUnknown status
University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 2210)
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BaltimoreUnited StatesUnknown status
Johns Hopkins University-The Sidney Kimmel Comprehensive Cancer Center ( Site 2206)
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BaltimoreUnited StatesUnknown status
Roswell Park Cancer Institute ( Site 2220)
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BuffaloUnited StatesUnknown status
University Hospitals Cleveland Medical Center ( Site 2214)
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ClevelandUnited StatesUnknown status
Cleveland Clinic-Taussig Cancer Center ( Site 2203)
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ClevelandUnited StatesUnknown status
Cancer and Hematology Centers of Western Michigan ( Site 2222)
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Grand RapidsUnited StatesUnknown status
University of Kentucky Chandler Medical Center ( Site 2201)
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LexingtonUnited StatesUnknown status
UCLA Hematology/Oncology - Santa Monica ( Site 2208)
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Los AngelesUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey ( Site 2217)
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New BrunswickUnited StatesUnknown status
AHN West Penn Hospital ( Site 2213)
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PittsburghUnited StatesUnknown status
UPMC Hillman Cancer Center ( Site 2205)
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PittsburghUnited StatesUnknown status
Fred Hutchinson Cancer Center ( Site 2212)
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SeattleUnited StatesUnknown status
Moffitt Cancer Center ( Site 2200)
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TampaUnited StatesUnknown status
Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site
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TorranceUnited StatesUnknown status
The University of Arizona Cancer Center - North Campus ( Site 2216)
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TucsonUnited StatesUnknown status
Hacettepe Universite Hastaneleri-Department of Hematology ( Site 2006)
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AnkaraTurkey (Türkiye)Unknown status
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 2000)
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AnkaraTurkey (Türkiye)Unknown status
Antalya Egitim ve Arastırma Hastanesi ( Site 2011)
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AntalyaTurkey (Türkiye)Unknown status
Ege Universitesi Hastanesi ( Site 2001)
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IzmirTurkey (Türkiye)Unknown status
Kocaeli Üniversitesi-Hematology ( Site 2009)
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KocaeliTurkey (Türkiye)Unknown status
Mega Medipol-Hematology ( Site 2005)
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StanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.