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

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06961006
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intismeran autogene — BIOLOGICAL
    IM injection
  • Pembrolizumab — BIOLOGICAL
    IV infusion
  • Placebo — OTHER
    IM injection

Study Details

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 receive intismeran autogene 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.

Key Dates

Start date
May 29, 2025
Status verified
Apr 2026
Primary completion
Jul 22, 2028
Completion
Sep 5, 2031

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intismeran autogene + Pembrolizumab
    Participants will receive 1 mg of intismeran autogene via intramuscular (IM) injection every 3 weeks (q3w) for up to 9 doses (up to approximately 27 weeks) plus 400 mg of pembrolizumab via intravenous (IV) infusion every 6 weeks (q6w) for up to 17 doses, or for a total treatment duration of up to approximately 2 years, or until disease progression or discontinuation.
  • Active Comparator: Placebo + Pembrolizumab
    Participants will receive placebo via IM injection q3w for up to 9 doses (up to approximately 27 weeks) plus 400 mg of pembrolizumab via IV infusion q6w for up to 17 doses, or for a total treatment duration of up to approximately 2 years, or until disease progression or discontinuation.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to approximately 36 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Highlands Oncology Group ( Site 4042)SpringdaleArkansas72762
Study Coordinator
479-872-8130
UCSF Medical Center at Mission Bay ( Site 4044)San FranciscoCalifornia94158
Study Coordinator
877-827-3222
John Theurer Cancer Center at Hackensack University Medical Center ( Site 4047)HackensackNew Jersey07601
Study Coordinator
551-996-1777
Inova Schar Cancer Institute ( Site 4046)FairfaxVirginia22031
Study Coordinator
571-472-0237
Fred Hutchinson Cancer Center ( Site 4041)SeattleWashington98109
Study Coordinator
206-606-7341

Find similar trials in Springdale, AR

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Highlands Oncology Group· Springdale, ARUCSF Medical Center at Mission Bay· San Francisco, CAJohn Theurer Cancer Center at Hackensack University Medical Center· Hackensack, NJInova Schar Cancer Institute· Fairfax, VAFred Hutchinson Cancer Center· Seattle, WA

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