A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)

Researchers want to learn if intismeran autogene 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. Intismeran autogene 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 r

Trial Details

NCT ID

NCT06961006

Phase

PHASE2

Sponsor

Merck Sharp & Dohme LLC

Status

RECRUITING

Cancer Type

Melanoma

Interventions

Intismeran autogene
Pembrolizumab
Placebo

Locations (sample)

Springdale, Arkansas, United States|36.18674,-94.12881
San Francisco, California, United States|37.77493,-122.41942
Hackensack, New Jersey, United States|40.88593,-74.04347
Fairfax, Virginia, United States|38.84622,-77.30637
Seattle, Washington, United States|47.60621,-122.33207

Key Eligibility Criteria

The main inclusion criteria include but are not limited to the following:
Has unresectable and histologically confirmed Stage III or IV cutaneous melanoma per American Joint Committee on Cancer (AJCC) Eighth Edition guide…
Has been untreated for melanoma except if participant received prior adjuvant or neoadjuvant therapy with targeted therapy or immunotherapy (such a…
Have documentation of serine/threonine-protein kinase B-raf (BRAF) V600-activating mutation status or had BRAF V600 mutation testing per local inst…

For full eligibility, visit ClinicalTrials.gov.

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