Study of MK-7162 in Combination With Pembrolizumab (MK-3475) in Adult Participants With Advanced Solid Tumours (MK-7162-002)

Official Title

Phase 1b Open-label Study of MK-7162 in Combination With Pembrolizumab (MK-3475) +/- Other Therapies in Participants With Advanced Solid Tumours

Summary:

The purposes of this study are to: 1) determine the safety and tolerability of MK-7162 when administered in combination with pembrolizumab (MK-3475), 2) establish a preliminary recommended Phase 2 dose (RP2D) of MK-7162 when administered in combination with pembrolizumab, and 3) assess the pharmacokinetics and pharmacodynamics of MK-7162 when administered in combination with pembrolizumab and other therapies to adult participants with advanced solid tumours.

Trial Description

Primary Outcome:

  • Dose-limiting Toxicities (DLTs) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 by the Investigator
  • Adverse Events (AEs)
  • Discontinuations of Study Treatment Due to an AE
Secondary Outcome:
  • MK-7162 Area Under the Concentration-Time Curve (AUC) When Administered Alone and in Combination with Pembrolizumab
  • MK-7162 Minimum Observed Concentration (Cmin) When Administered Alone and in Combination with Pembrolizumab
  • MK-7162 Maximum Observed Concentration (Cmax) When Administered Alone and in Combination with Pembrolizumab
  • Ratio of Kynurenine (KYN):Tryptophan (TRP) Biomarker Plasma Concentrations
  • Objective Response Rate (ORR) Based on Response Evaluation Criteria In Solid Tumours Version 1.1 (RECIST 1.1) as Assessed by the Investigator
  • ORR Based on Immune-related RECIST (irRECIST) as Assessed by the Investigator

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