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NCT03948763 · ClinicalTrials.gov registry record · Phase 1
A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Terminated
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT03948763: Clinical Trial Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT03948763 is a Phase 1 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03948763, a Phase 1 study, was terminated before completion, sponsored by Merck Sharp & Dohme.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study Summary
This study will determine the safety and tolerability and establish a preliminary recommended Phase 2 dose of V941(mRNA-5671/V941) as a monotherapy and in combination with pembrolizumab infusion.
Primary Outcome
The following toxicities graded for severity using National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE), were considered a DLT if judged by the investigator to be possibly related to study investigational products: 1) Grade 4 nonhematologic toxicity (ie. not a laboratory finding). 2) Grade 4 hematologic toxicity lasting ≥ 7 days, except thrombocytopenia: 3) Grade 4 thrombocytopenia of any duration 4) Grade 3 thrombocytopenia associated with clinically significant bleedin
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL V941
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2019-06-26 |
| Est. Completion | 2022-08-25 |
| Phase | Phase 1 |
Why NCT03948763 stopped before completion
NCT03948763 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03948763 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03948763 about?
NCT03948763 is a clinical study titled "A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)". This study will determine the safety and tolerability and establish a preliminary recommended Phase 2 dose of V941(mRNA-5671/V941) as a monotherapy and in combination with pembrolizumab infusion.
What is the current status of trial NCT03948763?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2019-06-26. Estimated completion is 2022-08-25.
What interventions are being tested in trial NCT03948763?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), V941 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03948763?
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 NCT03948763's enrollment target sits among peer trials
70 749th of 2000 higher than 1,227 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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