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NCT04303169 · ClinicalTrials.gov registry record · Phase 1
Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 146
- Enrollment target
NCT04303169: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT04303169 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 146 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (143% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04303169, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 146 participants
- Enrollment target
Study Summary
Substudy 02C is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study. The goal of substudy 02C is to evaluate the safety and efficacy of investigational treatment arms in participants with Stage III melanoma who are candidates for neoadjuvant therapy to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available. Arm 1: Pembrolizumab + Vibostolimab, Arm 2: Pembrolizumab + Gebasaxturev, and Arm 3: Pembrolizumab were added in the base protocol on 13-Nov-2019, and enrollment into those arms has been completed. Arm 4: Pembrolizumab + MK-4830 was added in Amendment 04 on 20-Dec-2021, and enrollment into that arm has been completed. Arm 5: Favezelimab + Pembrolizumab and Arm 6: Pembrolizumab + all-trans retinoic acid (ATRA) were added in Amendment 06 on 25-Jun-2022, and enrollment is ongoing.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced an AE was reported.
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL MK-4830
- BIOLOGICAL Vibostolimab
- BIOLOGICAL Gebasaxturev
- BIOLOGICAL Favezelimab + Pembrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2020-06-26 |
| Est. Completion | 2025-09-24 |
| Phase | Phase 1 |
What the finished NCT04303169 record still lists
NCT04303169 is an interventional study that assigns participants to a tested intervention. The registered 146 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 (143% higher).
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04303169 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04303169 about?
NCT04303169 is a clinical study titled "Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02)". Substudy 02C is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study. The goal of substudy 02C is to evaluate the safety and efficacy of investigational treatment arms in participants with Stage III melan...
What is the current status of trial NCT04303169?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 146 participants. The study started on 2020-06-26. Estimated completion is 2025-09-24.
What interventions are being tested in trial NCT04303169?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), MK-4830 (BIOLOGICAL), Vibostolimab (BIOLOGICAL), Gebasaxturev (BIOLOGICAL), Favezelimab + Pembrolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04303169?
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 NCT04303169's enrollment target sits among peer trials
146 391st of 2000 higher than 1,610 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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