A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)

Who can join: the full rules

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has surgically resected and histologically/pathologically confirmed diagnosis of Stage IIB or IIC, III, or IV cutaneous melanoma
* Has not received any prior systemic therapy for their melanoma beyond surgical resection
* No more than 13 weeks have passed between final surgical resection that rendered the participant disease-free and the first dose of pembrolizumab
* Is disease free at the time of providing documented consent for the study
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has ocular or mucosal melanoma
* Has cancer that has spread to other parts of the body and cannot be removed with surgery
* Has heart failure within the past 6 months
* Has received prior cancer therapy or another cancer vaccine
* Has another known cancer that that has spread to other parts of the body or has required treatment within the past 3 years
* Has severe reaction to study medications or any of their substance used to prepare a drug
* Have not recovered from major surgery or have ongoing surgical complications

Where it's running

• Highlands Oncology Group ( Site 1943)
  Springdale, Arkansas, United States
• UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918)
  Los Angeles, California, United States
• UCSF Medical Center at Mission Bay ( Site 1929)
  San Francisco, California, United States
• Yale-New Haven Hospital-Yale Cancer Center ( Site 1933)
  New Haven, Connecticut, United States
• Orlando Health Cancer Institute ( Site 1937)
  Orlando, Florida, United States
• Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 1945)
  Tampa, Florida, United States

+115 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Medical Director — Merck Sharp & Dohme LLC

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.