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)

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 3

Conditions: Hodgkin Lymphoma

Treatments: Drug: gemcitabine; Drug: bendamustine; Biological: favezelimab/pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05508867

2023-503615-14 (Registry Identifier)

MK-4280A-008 (Other Identifier)

2022-000371-39 (EudraCT Number)

4280A-008

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

360 participants in 2 patient groups

Favezelimab/Pembrolizumab

Experimental group

Description:

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.

Treatment:

Biological: favezelimab/pembrolizumab

Chemotherapy (Bendamustine or Gemcitabine)

Active Comparator group

Description:

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.

Treatment:

Drug: bendamustine

Drug: gemcitabine