Efficacy and Safety Study of Navarixin (MK-7123) in Combination With Pembrolizumab (MK-3475) in Adults With Selected Advanced/Metastatic Solid Tumours (MK-7123-034)

Official Title

A Phase II Study of Navarixin (MK-7123) in Combination With Pembrolizumab (MK-3475) in Participants With Selected Advanced/Metastatic Solid Tumours

Summary:

The purpose of this study is to assess the efficacy and safety of navarixin (MK-7123) in combination with pembrolizumab (MK-3475) in adults with one of three types of solid tumours: Programmed Death-Ligand 1 (PD-L1) positive refractory non-small cell lung cancer (NSCLC), castration resistant prostate cancer (CRPC) or 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) During Cycle 1
  • Adverse Events (AEs)
  • Study Treatment Discontinuations Due to an AE
Secondary Outcome:
  • Objective Response Rate (ORR) Per Modified RECIST 1.1 for Immune-based Therapeutics (iRECIST)
  • Progression-free Survival (PFS) Per RECIST 1.1
  • PFS Per iRECIST
  • Overall Survival (OS)
  • Absolute Neutrophil Counts (ANC)-related AEs
  • Navarixin Area Under the Plasma Concentration-Time Curve (AUC)
  • Navarixin Maximum Plasma Concentration (Cmax)
  • Navarixin Trough Plasma Concentration (Ctrough)

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