NCT03598608

Study to Evaluate the Safety and Efficacy of a Combination of Favezelimab (MK-4280) and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies (MK-4280-003)

A Phase 1/Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of favezelimab (MK-4280) in combination with pembrolizumab (MK-3475) using a non-randomized study design in participants with the following hematological malignancies: * classical Hodgkin lymphoma (cHL) * diffuse large B-cell lymphoma (DLBCL) * indolent non-Hodgkin lymphoma (iNHL) This study will also evaluate the safety and efficacy of pembrolizumab or favezelimab administered as monotherapy in participants with cHL using a 1:1 randomized study design. The study will have 2 phases: a safety lead-in and an efficacy expansion phase. The recommended Phase 2 dose (RP2D) will be determined in the safety lead-in phase by evaluating dose-limiting toxicities. There is no primary hypothesis for this study.

Detailed description

Per protocol amendment 7, the secondary serum concentration endpoints were removed and will not be reported.

Conditions

• Hodgkin Disease
• Lymphoma, Non-Hodgkin
• Lymphoma, B-Cell

Interventions

Type	Name	Description
BIOLOGICAL	pembrolizumab	Administered as an IV infusion every 3 weeks (Q3W)
BIOLOGICAL	Favezelimab	Administered as an IV infusion Q3W

Timeline

• Start date: 2018-10-17
• Primary completion: 2026-01-28
• Completion: 2026-01-28
• First posted: 2018-07-26
• Last updated: 2026-02-05

Locations

25 sites across 6 countries: United States, Australia, Canada, Germany, Israel, Italy

Regulatory

• FDA-regulated drug study