A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Zdiagnozowany zaawansowany czerniak skóry, którego nie można usunąć operacyjnie.
- •Nie byli wcześniej leczeni czerniaka lub leczono ich wcześniej, ale choroba powróciła po ponad roku od zakończenia leczenia.
- •Ich nowotwór posiada określone zmiany genetyczne (BRAF V600), niezależnie od tego czy badanie genetyczne zostało wykonane, czy nie.
- •Mają przynajmniej jedną zmianę nowotworową widoczną na badaniach obrazowych (np. tomografia komputerowa).
- •Dostarczyli próbkę guza do dalszych badań genetycznych.
- •Osoby zakażone wirusem HIV muszą mieć dobrze kontrolowane zakażenie.
- •Osoby zakażone wirusem zapalenia wątroby typu B (WZW B) muszą być pod opieką i mieć niewykrywalny poziom wirusa.
- •Osoby z przebytym zapaleniem wątroby typu C (WZW C) muszą mieć niewykrywalny poziom wirusa.
✗ Disqualifies
- •Ciężka niewydolność serca.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 2, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (38)
Highlands Oncology Group ( Site 4042)
Springdale, United States
UCSF Medical Center at Mission Bay ( Site 4044)
San Francisco, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 4047)
Hackensack, United States
Inova Schar Cancer Institute ( Site 4046)
Fairfax, United States
Fred Hutchinson Cancer Center ( Site 4041)
Seattle, United States
Blacktown Hospital ( Site 2001)
Blacktown, Australia
Melanoma Institute Australia ( Site 2000)
Wollstonecraft, Australia
One Clinical Research ( Site 2002)
Nedlands, Australia
William Osler Health System (Brampton Civic Hospital) ( Site 2023)
Brampton, Canada
Sunnybrook Research Institute ( Site 2022)
Toronto, Canada
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 2042)
Nice, France
Hôpital Saint-Louis ( Site 2041)
Paris, France
Gustave Roussy ( Site 2040)
Villejuif, France
NCT ( Site 2065)
Heidelberg, Germany
Universitätsklinikum Frankfurt Goethe-Universität ( Site 2063)
Frankfurt am Main, Germany
Universitaetsklinikum Koeln ( Site 2064)
Cologne, Germany
Universitaetsklinikum Essen ( Site 2061)
Essen, Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 2060)
Hamburg, Germany
General Hospital of Athens "Laiko" ( Site 2080)
Athens, Greece
Metropolitan Hospital ( Site 2082)
Athens, Greece
European Interbalkan Medical Center ( Site 2081)
Thessaloniki, Greece
HaEmek Medical Center ( Site 3003)
Afula, Israel
Hadassah Medical Center ( Site 3001)
Jerusalem, Israel
Rabin Medical Center ( Site 3002)
Petah Tikva, Israel
Sheba Medical Center ( Site 3000)
Ramat Gan, Israel
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 3021)
Milan, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 3020)
Naples, Italy
Istituto Oncologico Veneto IRCCS ( Site 3022)
Padova, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 3023)
Roma, Italy
Harbour Cancer & Wellness ( Site 3040)
Auckland, New Zealand
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 3061)
Poznan, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 3060)
Warsaw, Poland
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 4002)
Lisbon, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 4001)
Lisbon, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 4000)
Porto, Portugal
Hospital Universitari Vall d'Hebron ( Site 3081)
Barcelona, Spain
Hospital Clínic Barcelona ( Site 3080)
Barcelona, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 3082)
Madrid, Spain
Trial contact
Toll Free Number
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.