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 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)
ClinicalTrials.gov ID: NCT05508867
Sponsor: Merck Sharp & Dohme LLC
Information provided by: Merck Sharp & Dohme LLC (Responsible Party)
Last Update Posted: 2024-04-08
Brief Summary:
The purpose of this study is to compare efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) with physician's choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory, relapsed or refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of coformulated favezelimab/pembrolizumab. The primary study hypotheses are that coformulated favezelimab/pembrolizumab is superior to physician's choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS).
Official Title:
A Phase 3 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)
Intervention / Treatment:
- Biological: favezelimab/pembrolizumab
- Drug: bendamustine
- Drug: gemcitabine
| Category | Value |
|---|---|
| Study Start (Actual) |
2022-10-18
|
| Primary Completion (Estimated) | 2027-05-25 |
| Study Completion (Estimated) | 2031-06-16 |
| Enrollment (Estimated) | 360 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
4280A-008
MK-4280A-008 (Other Identifier) (OTHER: Merck) 2023-503615-14 (Registry Identifier) (REGISTRY: EU CT) 2022-000371-39 (EudraCT Number) |