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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

CompletedPhase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: Hodgkin Lymphoma

Interventions: favezelimab/pembrolizumab, bendamustine, gemcitabine

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Locations (105)

Tucson, Arizona, United States
Los Angeles, California, United States
Torrance, California, United States
Tampa, Florida, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Ann Arbor, Michigan, United States
Grand Rapids, Michigan, United States
New Brunswick, New Jersey, United States
Buffalo, New York, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Seattle, Washington, United States
Buenos Aires, Argentina
Mendoza, Argentina
Townsville, Queensland, Australia
Adelaide, South Australia, Australia
St Albans, Victoria, Australia
Perth, Western Australia, Australia
Leuven, Vlaams-Brabant, Belgium
Namur, Belgium
Barretos, São Paulo, Brazil
São Paulo, Brazil
Edmonton, Alberta, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
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