OncoMatch/Clinical Trials/NCT06961006
A Clinical Study of V940 and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)
Is NCT06961006 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including V940 and Pembrolizumab for malignant melanoma.
Treatment: V940 · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Biomarker criteria
Allowed: BRAF V600-activating mutation
Have documentation of serine/threonine-protein kinase B-raf (BRAF) V600-activating mutation status or had BRAF V600 mutation testing per local institutional standards during the screening period (participants with BRAF mutation positive melanoma as well as BRAF wild-type or unknown are eligible).
Allowed: BRAF wild-type
participants with BRAF mutation positive melanoma as well as BRAF wild-type or unknown are eligible
Disease stage
Required: Stage III, IV
Prior therapy
Must have received: targeted therapy — adjuvant or neoadjuvant
prior adjuvant or neoadjuvant therapy with targeted therapy or immunotherapy (such as anti-cytotoxic T-lymphocyte-associated protein [CTLA-4], anti-programmed cell death 1 protein [PD-1] therapy or interferon), and only if relapse did not occur within 12 months after treatment discontinuation
Must have received: immunotherapy (anti-CTLA-4, anti-PD-1, interferon) — adjuvant or neoadjuvant
prior adjuvant or neoadjuvant therapy with targeted therapy or immunotherapy (such as anti-cytotoxic T-lymphocyte-associated protein [CTLA-4], anti-programmed cell death 1 protein [PD-1] therapy or interferon), and only if relapse did not occur within 12 months after treatment discontinuation
Cannot have received: anti-PD-1 therapy
Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, lymphocyte activation gene 3 [LAG-3], tumor necrosis factor receptors [OX-40 or CD137]), with some exceptions.
Cannot have received: systemic anticancer therapy
Exception: adjuvant or neoadjuvant targeted therapy or immunotherapy allowed if relapse did not occur within 12 months after treatment discontinuation
Received prior systemic anticancer therapy for melanoma before randomization, with some exceptions.
Cannot have received: radiation therapy
Received prior radiotherapy within 2 weeks of start of study intervention or has ongoing radiation related toxicities.
Cannot have received: cancer vaccine
Received prior treatment with another universal or personalized cancer vaccine.
Lab requirements
Cardiac function
No clinically significant heart failure, defined as New York Heart Association class III or IV, within the past 6 months, unless well controlled
Has clinically significant heart failure, defined as New York Heart Association class III or IV, within the past 6 months, unless the disease is well controlled in the opinion of the investigator.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Highlands Oncology Group ( Site 4042) · Springdale, Arkansas
- UCSF Medical Center at Mission Bay ( Site 4044) · San Francisco, California
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 4047) · Hackensack, New Jersey
- Inova Schar Cancer Institute ( Site 4046) · Fairfax, Virginia
- Fred Hutchinson Cancer Center ( Site 4041) · Seattle, Washington
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
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