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

Official Title

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

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).

Trial Description

Primary Outcome:

  • Number of Participants with a Dose-Limiting Toxicity (DLT)
  • Number of Participants Who Experienced an Adverse Event (AE)
  • Number of Participants Who Discontinued Study Treatment Due to an AE
Secondary Outcome:
  • Objective Response Rate (ORR)
  • Duration of Response (DOR)
  • Disease Control Rate (DCR)
  • Lowest Plasma Concentration (Ctrough) of Vibostolimab
  • Maximum Concentration (Cmax) of Vibostolimab

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society