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

Colorectal Cancer Clinical Trial

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

Clinical Trial 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) that is microsatellite stable (i.e., non-microsatellite instability-high/deficient mismatch repair [non-MSI-H/dMMR]) 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 has been amended to lower the starting doses of MK-8353 in combination with pembrolizumab. In addition, 3 arms have been added: one in which MK-8353 will be administered continuously once a day (QD) in combination with pembrolizumab, one optional arm in which MK-8353 will be administered 1 week on/1 week off QD in combination with pembrolizumab and one optional arm in which participants undergo a MK-8353 QD run-in period prior to starting combination therapy with pembrolizumab.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02972034
Study type Interventional
Source Merck Sharp & Dohme LLC
Contact
Status Completed
Phase Phase 1
Start date January 13, 2017
Completion date December 2, 2022
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