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
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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
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 2 years
Participants receive intismeran autogene or placebo via intramuscular injection every 3 weeks for up to 9 doses, combined with pembrolizumab administered intravenously every 6 weeks for up to 17 doses, or until disease progression or discontinuation.
IM injections every 3 weeks and IV infusions every 6 weeks during treatment
Trial Site Locations
Total: 38 locations
1
Highlands Oncology Group ( Site 4042)
Springdale, Arkansas, United States, 72762
Actively Recruiting
2
UCSF Medical Center at Mission Bay ( Site 4044)
San Francisco, California, United States, 94158
Actively Recruiting
3
John Theurer Cancer Center at Hackensack University Medical Center ( Site 4047)
Hackensack, New Jersey, United States, 07601
Actively Recruiting
4
Inova Schar Cancer Institute ( Site 4046)
Fairfax, Virginia, United States, 22031
Actively Recruiting
5
Fred Hutchinson Cancer Center ( Site 4041)
Seattle, Washington, United States, 98109
Actively Recruiting
6
Blacktown Hospital ( Site 2001)
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
7
Melanoma Institute Australia ( Site 2000)
Wollstonecraft, New South Wales, Australia, 2065
Actively Recruiting
8
One Clinical Research ( Site 2002)
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
9
William Osler Health System (Brampton Civic Hospital) ( Site 2023)
Brampton, Ontario, Canada, L6R 3J7
Actively Recruiting
10
Sunnybrook Research Institute ( Site 2022)
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
11
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 2042)
Nice, Alpes-Maritimes, France, 06202
Actively Recruiting
12
Hôpital Saint-Louis ( Site 2041)
Paris, Île-de-France Region, France, 75010
Actively Recruiting
13
Gustave Roussy ( Site 2040)
Villejuif, Île-de-France Region, France, 94800
Actively Recruiting
14
NCT ( Site 2065)
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
15
Universitätsklinikum Frankfurt Goethe-Universität ( Site 2063)
Frankfurt am Main, Hesse, Germany, 60590
Actively Recruiting
16
Universitaetsklinikum Koeln ( Site 2064)
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
17
Universitaetsklinikum Essen ( Site 2061)
Essen, North Rhine-Westphalia, Germany, 45147
Actively Recruiting
18
Universitaetsklinikum Hamburg-Eppendorf ( Site 2060)
Hamburg, Germany, 20251
Actively Recruiting
19
General Hospital of Athens "Laiko" ( Site 2080)
Athens, Attica, Greece, 115 27
Actively Recruiting
20
Metropolitan Hospital ( Site 2082)
Athens, Attica, Greece, 18547
Actively Recruiting
21
European Interbalkan Medical Center ( Site 2081)
Thessaloniki, Greece, 570 01
Actively Recruiting
22
HaEmek Medical Center ( Site 3003)
Afula, Israel, 1834111
Actively Recruiting
23
Hadassah Medical Center ( Site 3001)
Jerusalem, Israel, 9112001
Actively Recruiting
24
Rabin Medical Center ( Site 3002)
Petah Tikva, Israel, 4941492
Actively Recruiting
25
Sheba Medical Center ( Site 3000)
Ramat Gan, Israel, 5265601
Actively Recruiting
26
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 3021)
Milan, Milano, Italy, 20133
Actively Recruiting
27
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 3020)
Naples, Italy, 80131
Actively Recruiting
28
Istituto Oncologico Veneto IRCCS ( Site 3022)
Padova, Italy, 35128
Actively Recruiting
29
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 3023)
Roma, Italy, 00168
Actively Recruiting
30
Harbour Cancer & Wellness ( Site 3040)
Auckland, New Zealand, 1023
Actively Recruiting
31
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 3061)
Poznan, Greater Poland Voivodeship, Poland, 50 659
Actively Recruiting
32
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 3060)
Warsaw, Masovian Voivodeship, Poland, 02-781
Actively Recruiting
33
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 4002)
Lisbon, Lisbon District, Portugal, 1449-005
Actively Recruiting
34
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 4001)
Lisbon, Portugal, 1649-035
Actively Recruiting
35
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 4000)
Porto, Portugal, 4200-072
Actively Recruiting
36
Hospital Universitari Vall d'Hebron ( Site 3081)
Barcelona, Spain, 08035
Actively Recruiting
37
Hospital Clínic Barcelona ( Site 3080)
Barcelona, Spain, 08036
Actively Recruiting
38
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 3082)
Madrid, Spain, 28034
Actively Recruiting
Research Team
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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