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NCT04521621 · ClinicalTrials.gov registry record · Phase 1
A Study of Gebasaxturev (V937) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (V937-013)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Terminated
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
NCT04521621: Clinical Trial Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT04521621 is a Phase 1 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 76 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04521621, a Phase 1 study, was terminated before completion, sponsored by Merck Sharp & Dohme.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy in participants with advanced/metastatic or recurrent malignancies who receive gebasaxturev (V937) in combination with pembrolizumab (MK-3475). The primary objective for Part 1 is to evaluate the objective response rate, and the primary objective for Part 2 is to determine the safety and tolerability of gebasaxturev administered in combination with pembrolizumab. With Amendment 4, this study will be terminated once all participants who have completed or discontinued gebasaxturev treatment and are only receiving pembrolizumab may be enrolled in a pembrolizumab extension study, if available, to continue pembrolizumab monotherapy for up to 35 cycles from first pembrolizumab dose on V937-013.
Primary Outcome
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions and no new lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by investigator. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and to specify that intratumoral injection does not render a lesion non-eva
Interventions
- DRUG Pembrolizumab
- BIOLOGICAL Gebasaxturev
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2020-10-28 |
| Est. Completion | 2023-07-25 |
| Phase | Phase 1 |
Why NCT04521621 stopped before completion
NCT04521621 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04521621 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04521621 about?
NCT04521621 is a clinical study titled "A Study of Gebasaxturev (V937) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (V937-013)". The purpose of this study is to evaluate the safety, tolerability, and efficacy in participants with advanced/metastatic or recurrent malignancies who receive gebasaxturev (V937) in combination with pembrolizumab (MK-3475). The primary objective for Part 1 is to evaluate the objective response rate,...
What is the current status of trial NCT04521621?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2020-10-28. Estimated completion is 2023-07-25.
What interventions are being tested in trial NCT04521621?
The interventions under investigation include: Pembrolizumab (DRUG), Gebasaxturev (BIOLOGICAL).
Who is sponsoring clinical trial NCT04521621?
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 NCT04521621's enrollment target sits among peer trials
76 705th of 2000 higher than 1,290 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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