Study of MK-8353 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Malignancies (MK-8353-013)

Official Title

A Phase Ib Study to Evaluate the Safety and Tolerability of MK-8353 in Combination With Pembrolizumab in Patients With Advanced Malignancies

Summary:

This study will evaluate the safety, tolerability and preliminary efficacy of MK-8353 when administered in combination with pembrolizumab (MK-3475). There are two parts in this study: Part 1 will be dose escalation and confirmation, and Part 2 will be a cohort expansion. In Part 1, the recommended phase II dose (RP2D) of MK-8353 in combination with a fixed dose of pembrolizumab in participants with advanced malignancies will be identified and confirmed. Participants will be initially enrolled to receive MK-8353 at 350 mg twice a day (BID) in combination with pembrolizumab at a fixed dose of 200 mg on Day 1 of each 3-week cycle (Q3W) for up to 24 months of treatment. In Part 2, participants with advanced colorectal cancer (CRC) who received at least one and up to five prior lines of therapy will be enrolled at the RP2D in the expansion cohort to further evaluate safety and efficacy. The protocol was amended to add lower doses of MK-8353 in combination with pembrolizumab. In addition, 2 optional arms: one in which MK-8353 will be administered 1 week on/1 week off at a starting dose of 150 mg BID in combination with pembrolizumab and one in which MK-8353 will be administered continuously at a starting dose of 200 mg once a day (QD) in combination with pembrolizumab.

Trial Description

Primary Outcome:

  • Percentage of Participants Who Experience an Adverse Event (AE)
  • Percentage of Participants Who Discontinue Study Drug Due to an AE
  • Percentage of Participants Who Experience a Dose-limiting Toxicity (DLT)
Secondary Outcome:
  • Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) as Assessed by the Investigator

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society