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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 is a Phase 1 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 111 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02972034
The ClinicalTrials.gov registry entry for NCT02972034 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT02972034 reports 0 study locations.
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.
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