Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT04152863 is a Phase 2 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 85 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ORR was defined as the percentage of participants who experienced a Complete Response (CR: disappearance of all lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions, without evidence of progression based on non-target or new lesions) as assessed by BICR per RECIST 1.1 which was modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR base
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 |
Why NCT04152863 stopped before completion
NCT04152863 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04152863 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04152863's enrollment target sits among peer trials
85 820th of 2000 higher than 1,179 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00842283 · 85 participants
Role of Angiogenesis in Dermatologic Diseases: A Potential Therapeutic Target
- NCT02133196 · 85 participants · Phase 2
T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer
- NCT03823144 · 85 participants · NA
Intravital Microscopy in Human Solid Tumors
- NCT03875638 · 85 participants · Phase 2
Treating Hyperexcitability in AD With Levetiracetam
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI