Actively Recruiting
A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)
Led by Merck Sharp & Dohme LLC · Updated on 2026-04-13
160
Participants Needed
38
Research Sites
327 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 per AJCC Eighth Edition guidelines
- Untreated for melanoma except prior adjuvant or neoadjuvant targeted or immunotherapy if relapse did not occur within 12 months after stopping treatment
- Documented BRAF V600 mutation status or tested during screening
- At least 1 measurable lesion by CT or MRI per RECIST 1.1
- Provides tumor tissue suitable for next generation sequencing and biomarker analysis
- Well-controlled HIV on antiretroviral therapy if HIV positive
- Hepatitis B surface antigen positive patients eligible if on HBV antiviral therapy for at least 4 weeks and undetectable viral load
- History of hepatitis C infection eligible if viral load undetectable at screening
You will not qualify if you...
- Clinically significant heart failure (NYHA class III or IV) within past 6 months unless well controlled
- HIV-infected with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Ocular or mucosal melanoma
- Received blood transfusions or colony-stimulating factors within 2 weeks of screening blood sample
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other stimulatory/coinhibitory T-cell receptor agents with some exceptions
- Prior systemic anticancer therapy for melanoma before randomization with some exceptions
- Radiotherapy within 2 weeks before study intervention or ongoing radiation-related toxicities
- Live or live-attenuated vaccine within 30 days before first study dose
- Prior treatment with another universal or personalized cancer vaccine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
T
Toll Free Number
CONTACT
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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