NCT05005442

A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)

A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of MK-7684A (MK-7684 [Vibostolimab] With MK-3475 [Pembrolizumab] Coformulation) in Participants With Relapsed or Refractory Hematological Malignancies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the safety and tolerability of pembrolizumab/vibostolimab (MK-7684A) in hematological malignancies. This study will also evaluate the overall response rate (ORR), the duration of response (DOR), and disease control rate (DCR) following administration of pembrolizumab/vibostolimab. In addition, this study will characterize pharmacokinetic (PK) profile of vibostolimab (MK-7684).

Conditions

• Hematological Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab/vibostolimab coformulation	Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years.

Timeline

• Start date: 2021-09-28
• Primary completion: 2024-12-10
• Completion: 2024-12-10
• First posted: 2021-08-13
• Last updated: 2026-02-19
• Results posted: 2025-12-17

Locations

65 sites across 16 countries: United States, Brazil, Canada, Chile, Denmark, France, Germany, Hungary, Israel, Italy, Poland, Russia, Spain, Taiwan, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study