General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT06961006

Background Information

This trial is being done to test V940 and pembrolizumab (pembro) for safety and effectiveness in people with advanced melanoma. Pembrolizumab is approved by certain health authorities, such as the Food and Drug Administration (FDA), for treating advanced melanoma. V940 is an experimental drug. Participants may receive a combination of pembro and V940, or they may receive pembro and a placebo drug.

For more information, please visit: https://www.clinicaltrials.gov/study/NCT06961006

Offered At

Inova Schar Cancer
A Division of Inova Fairfax Hospital
8081 Innovation Park Drive
Fairfax, VA 22031
Principal Investigator

Sekwon Jang, MD

Eligibility Information

  • Age 18 or older
  • Unresectable and histologically confirmed Stage III or IV cutaneous melanoma
  • Documentation of BRAF V600-activating mutation status
  • At least 1 measurable lesion by CT or MRI per RECIST 1.1
  • HIV-infected participants must have well controlled HIV on ART
  • Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization
  • ECOG performance status of 0 to 1 assessed within 7 days before randomization
  • Adequate organ function
  • Additional eligibility in protocol.

Ineligibility Information

  • Pregnancy/breastfeeding
  • Clinically significant heart failure within the past 6 months, unless the disease is well controlled in the opinion of the
    investigator
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Ocular or mucosal melanoma
  • 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, LAG-3, OX-40, CD137)
  • Ongoing radiation related toxicities
  • Prior treatment with another universal or personalized cancer vaccine
  • Current chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
  • History of CNS metastases and/or carcinomatous meningitis
  • Severe hypersensitivity (≥Grade 3) to either V940 or pembrolizumab and/or any of their excipients
  • History of stem cell/solid organ transplant
  • Additional exclusion criteria in protocol.