NCT05508867

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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). 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.

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	favezelimab/pembrolizumab	Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion
DRUG	bendamustine	IV infusion
DRUG	gemcitabine	IV infusion

Timeline

• Start date: 2022-10-18
• Primary completion: 2025-09-03
• Completion: 2026-01-08
• First posted: 2022-08-19
• Last updated: 2026-01-20

Locations

105 sites across 20 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Israel, Mexico, Poland, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study