Actively Recruiting
A Phase 2, Randomized, Double-Blind Study of Intismeran Autogene V940 Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in People With First-Line Advanced Melanoma
Led by Merck Sharp & Dohme LLC · Updated on 2026-04-13
160
Participants Needed
38
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying if combining intismeran autogene with pembrolizumab can prevent advanced melanoma, a type of skin cancer that has spread and cannot be removed by surgery, from growing or spreading further. This study compares this combination to pembrolizumab with a placebo to see if patients live longer without their cancer worsening. The trial is a phase 2 randomized study designed to evaluate these treatments in people with advanced melanoma. Participants will be randomly assigned to receive either intismeran autogene via muscle injection every three weeks for up to nine doses plus pembrolizumab through an intravenous infusion every six weeks for up to 17 doses, or a placebo injection with the same pembrolizumab schedule. Treatment may continue for up to approximately two years or until the cancer progresses or the participant stops treatment. During the study, participants will be monitored with scans to measure tumor response and blood tests to assess safety and side effects. Researchers will measure how long patients live without their cancer progressing as the main outcome, along with response rates, duration of response, overall survival, and treatment-related adverse events. Participants may be involved in the study for up to about six years to fully assess these outcomes and monitor safety.
CONDITIONS
Brief Title
A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Unresectable and histologically confirmed Stage III or IV cutaneous melanoma
- No prior systemic anticancer therapy for melanoma except certain adjuvant or neoadjuvant therapies without relapse within 12 months
- Documentation of BRAF V600 mutation status or testing during screening
- At least one measurable tumor lesion by CT or MRI
- Provide tumor tissue suitable for sequencing and biomarker analysis
- Well-controlled HIV on antiretroviral therapy if applicable
- Hepatitis B positive treated with antiviral therapy and undetectable viral load
- History of hepatitis C with undetectable viral load at screening
You will not qualify if you...
- Clinically significant heart failure (NYHA class III or IV) within past 6 months unless well controlled
- History of Kaposi's sarcoma or Multicentric Castleman's Disease in HIV-infected participants
- Ocular or mucosal melanoma
- Recent blood transfusion or colony-stimulating factor use within 2 weeks before screening blood sample
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or other immune modulators except some exceptions
- Prior systemic anticancer therapy for melanoma before randomization except some exceptions
- Radiotherapy within 2 weeks before study intervention or ongoing radiation toxicities
- Live or live-attenuated vaccine within 30 days before first study dose
- Prior treatment with other universal or personalized cancer vaccines
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