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NCT02972034 · ClinicalTrials.gov registry record · Phase 1
Study of MK-8353 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Malignancies (MK-8353-013)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Terminated
- Registry status
- Phase 1
- Development phase
- 111
- Enrollment target
NCT02972034: Clinical Trial Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT02972034 is a Phase 1 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 111 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02972034, a Phase 1 study, was terminated before completion, sponsored by Merck Sharp & Dohme.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 111 participants
- Enrollment target
Study 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.
Primary Outcome
Number of participants who experienced an AE was defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study treatment
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG MK-8353
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2017-01-13 |
| Est. Completion | 2022-12-02 |
| Phase | Phase 1 |
Why NCT02972034 stopped before completion
NCT02972034 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% higher).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT02972034 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02972034 about?
NCT02972034 is a clinical study titled "Study of MK-8353 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Malignancies (MK-8353-013)". 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 p...
What is the current status of trial NCT02972034?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 111 participants. The study started on 2017-01-13. Estimated completion is 2022-12-02.
What interventions are being tested in trial NCT02972034?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), MK-8353 (DRUG).
Who is sponsoring clinical trial NCT02972034?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02972034's enrollment target sits among peer trials
111 512th of 2000 higher than 1,487 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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