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NCT06961006 · ClinicalTrials.gov registry record · Phase 2
A Clinical Study of V940 and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)
A Phase 2 study of Malignant Melanoma, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT06961006: Recruiting Phase 2 study of Malignant Melanoma, sponsored by Merck Sharp & Dohme.
NCT06961006 is a Phase 2 study of Malignant Melanoma that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 160 participants, below the 177-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06961006, a Phase 2 study of Malignant Melanoma, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study Summary
Researchers want to learn if V940 with pembrolizumab can stop advanced melanoma from growing or spreading. Melanoma is a type of skin cancer. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. A standard (or usual) treatment for advanced melanoma is immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. V940 is a study treatment designed to help a person's immune system attack their specific cancer. Pembrolizumab is an immunotherapy. The goal of this study is to learn if people who receive V940 with pembrolizumab live longer without the cancer growing or spreading than people who receive placebo with pembrolizumab. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment.
Primary Outcome
PFS is defined as the time from randomization to the first documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by investigator assessment or death due to any cause, whichever occurs first. Progressive disease (PD) is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PF
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Placebo
- BIOLOGICAL V940
Study Locations (20)
New South Wales
- Blacktown Hospital ( Site 2001) - Blacktown
- Melanoma Institute Australia ( Site 2000) - Wollstonecraft
Ontario
- William Osler Health System (Brampton Civic Hospital) ( Site 2023) - Brampton
- Sunnybrook Research Institute ( Site 2022) - Toronto
Île-de-France Region
- Hôpital Saint-Louis ( Site 2041) - Paris
- Gustave Roussy ( Site 2040) - Villejuif
North Rhine-Westphalia
- Universitaetsklinikum Koeln ( Site 2064) - Cologne
- Universitaetsklinikum Essen ( Site 2061) - Essen
Attica
- General Hospital of Athens "Laiko" ( Site 2080) - Athens
- Metropolitan Hospital ( Site 2082) - Athens
Arkansas
- Highlands Oncology Group ( Site 4042) - Springdale
California
- UCSF Medical Center at Mission Bay ( Site 4044) - San Francisco
New Jersey
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 4047) - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2025-05-29 |
| Est. Completion | 2031-09-05 |
| Phase | Phase 2 |
What NCT06961006 shows while recruiting
NCT06961006 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 177-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (10% lower).
The record links to 1 condition, with Malignant Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT06961006 names 20 study sites across 15 states, led by New South Wales, Ontario, Île-de-France Region.
Frequently Asked Questions
What is clinical trial NCT06961006 about?
NCT06961006 is a clinical study titled "A Clinical Study of V940 and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)". Researchers want to learn if V940 with pembrolizumab can stop advanced melanoma from growing or spreading. Melanoma is a type of skin cancer. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. A standard (or usual) treatment for advanced melanoma is i...
What is the current status of trial NCT06961006?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2025-05-29. Estimated completion is 2031-09-05.
What conditions does trial NCT06961006 study?
This clinical trial studies the following conditions: Malignant Melanoma.
What interventions are being tested in trial NCT06961006?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (OTHER), V940 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06961006?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06961006 being conducted?
This trial has 20 study locations across Arkansas, California, New Jersey, Virginia, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06961006's enrollment target sits among peer trials
160 6th of 28 higher than 23 of 28 other Malignant Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Melanoma 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.
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