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)
Completed · Phase 2
Conditions studied: Hodgkin Lymphoma
In brief
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.
Key facts
- Study ID
- NCT05508867
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 203
- Starts
- 2022-10-18
- Expected to finish
- 2026-01-08
- Last updated by the study team
- 2026-01-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- 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
- The University of Arizona Cancer Center - North Campus ( Site 2216) — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.