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NCT03783078 · ClinicalTrials.gov registry record · Phase 3
Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 55
- Enrollment target
NCT03783078: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03783078 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 55 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03783078, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 55 participants
- Enrollment target
Study Summary
This is a single-arm, open-label, multicenter, efficacy, and safety study of pembrolizumab in adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma (MCC). The primary objective of the trial is to assess the objective response rate, as assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, following administration of pembrolizumab.
Primary Outcome
ORR was defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). The percentage of participants who experienced CR or PR as assessed by blinded independent central review (BICR) were presented.
Interventions
- DRUG Pembrolizumab (MK-3475)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2019-02-25 |
| Est. Completion | 2024-02-15 |
| Phase | Phase 3 |
What the finished NCT03783078 record still lists
NCT03783078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Pembrolizumab (MK-3475) is the first listed.
NCT03783078 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03783078 about?
NCT03783078 is a clinical study titled "Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)". This is a single-arm, open-label, multicenter, efficacy, and safety study of pembrolizumab in adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma (MCC). The primary objective of the trial is to assess the objective response rate, as assessed by blinded independe...
What is the current status of trial NCT03783078?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 55 participants. The study started on 2019-02-25. Estimated completion is 2024-02-15.
What interventions are being tested in trial NCT03783078?
The interventions under investigation include: Pembrolizumab (MK-3475) (DRUG).
Who is sponsoring clinical trial NCT03783078?
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 NCT03783078's enrollment target sits among peer trials
55 1834th of 2000 higher than 163 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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