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NCT04152863 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety, and Tolerability of Gebasaxturev (V937) Administered Intravenously or Intratumorally With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma (V937-011)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Terminated
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
NCT04152863 is a Phase 2 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 85 participants.
The verdict
NCT04152863, a Phase 2 study, was terminated before completion, sponsored by Merck Sharp & Dohme.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
Study Summary
This is a Phase 2 study to assess the efficacy, safety, and tolerability of gebasaxturev administered both intratumorally (ITu) and intravenously (IV) as combination therapy with pembrolizumab (MK-3475) versus pembrolizumab alone in anti-programmed cell death ligand 1 (anti-PD-L1)-treatment-naive participants with advanced/metastatic melanoma. The primary hypothesis of the study is that gebasaxturev administered either ITu or IV in combination with pembrolizumab results in a superior objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR), compared to pembrolizumab alone. This study will be terminated once all participants finish treatment with V937. Participants eligible to continue to receive pembrolizumab will be transferred to MK-3475-587 study.
Interventions
- DRUG Pembrolizumab
- BIOLOGICAL Gebasaxturev IV
- BIOLOGICAL Gebasaxturev ITu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2020-06-05 |
| Est. Completion | 2023-07-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04152863
The ClinicalTrials.gov registry entry for NCT04152863 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 85 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 3 interventions - of which Pembrolizumab is the first listed.
NCT04152863 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04152863 about?
NCT04152863 is a clinical study titled "Efficacy, Safety, and Tolerability of Gebasaxturev (V937) Administered Intravenously or Intratumorally With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma (V937-011)". This is a Phase 2 study to assess the efficacy, safety, and tolerability of gebasaxturev administered both intratumorally (ITu) and intravenously (IV) as combination therapy with pembrolizumab (MK-3475) versus pembrolizumab alone in anti-programmed cell death ligand 1 (anti-PD-L1)-treatment-naive pa...
What is the current status of trial NCT04152863?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2020-06-05. Estimated completion is 2023-07-12.
What interventions are being tested in trial NCT04152863?
The interventions under investigation include: Pembrolizumab (DRUG), Gebasaxturev IV (BIOLOGICAL), Gebasaxturev ITu (BIOLOGICAL).
Who is sponsoring clinical trial NCT04152863?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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