Safety and Efficacy of Vicriviroc (MK-7690) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC) (MK-7690-046)

Official Title

A Phase 2 Trial to Evaluate the Safety and Efficacy of Vicriviroc (MK-7690) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC)

Summary:

This trial will evaluate the safety and efficacy of vicriviroc (MK-7690) at 2 dose levels in combination with pembrolizumab (MK-3475) in participants with advanced/metastatic microsatellite stable (MSS) colorectal cancer (CRC).

Trial Description

Primary Outcome:

  • Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1)
  • Dose-Limiting Toxicities (DLTs)
  • Adverse Events (AEs)
  • Treatment Discontinuations due to Adverse Events
Secondary Outcome:
  • Objective Response Rate (ORR) based on Modified Response Evaluation Criteria in Solid Tumours 1.1 for Immune-based Therapeutics (iRECIST)
  • Progression-Free Survival (PFS)
  • Overall Survival (OS)
  • Area Under the Concentration vs Time Curve (AUC) of Vicriviroc in Plasma
  • Maximum Observed Plasma Concentration (Cmax) of Vicriviroc
  • Trough Plasma Concentration (Ctrough) of Vicriviroc

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