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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 is a Phase 1 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 76 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04521621
The ClinicalTrials.gov registry entry for NCT04521621 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 76 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.
NCT04521621 reports 0 study locations.
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.
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