IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Launched by IMMUNOCORE LTD · Oct 31, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called PRISM-MEL-301, is exploring a new treatment for patients with advanced melanoma, specifically looking at a combination of two medications: IMC-F106C and nivolumab. The study is comparing this new combination to the standard nivolumab treatment to see which works better for patients who have not received any treatment before. To participate, individuals must have a specific genetic marker (HLA-A\*02:01) and must have confirmed advanced melanoma that is either Stage IV or unresectable Stage III.
Eligible participants are typically adults aged 65 to 74 who have a measurable form of the disease and a good overall health status. They should not have a history of other cancers or certain serious health conditions that could interfere with the trial. Participants will receive the study treatment and will be monitored closely throughout the trial. It's important for those who could become pregnant to use effective birth control during the study and for a time afterward. If you're interested in participating or want more information, it's a good idea to talk to your doctor about whether this trial might be right for you.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participants must be HLA-A\*02:01-positive
- • Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma
- • Archived or fresh tumor tissue sample that must be confirmed as adequate
- • Participants must have measurable disease per RECIST 1.1
- • Participant must have BRAF V600 mutation status determined
- • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- • Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention
- Exclusion Criteria:
- • Participants with a history of a malignant disease other than those being treated in this study
- • Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis
- • Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients
- • Participants with clinically significant pulmonary disease or impaired lung function
- • Participants with clinically significant cardiac disease or impaired cardiac function
- • Participants with active autoimmune disease requiring immunosuppressive treatment
- • Participants with any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results
- • Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma
- • Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3
About Immunocore Ltd
Immunocore Ltd. is a pioneering biotechnology company focused on transforming the treatment landscape for cancer and other serious diseases through its innovative T-cell receptor (TCR) technology. By harnessing the unique capabilities of T-cells to recognize and target disease-associated antigens, Immunocore is dedicated to developing novel immunotherapies that aim to enhance patient outcomes. The company’s robust pipeline includes advanced clinical trials designed to evaluate the safety and efficacy of its proprietary TCR-based therapies, underscoring its commitment to precision medicine and the advancement of next-generation immuno-oncology solutions. With a strong emphasis on scientific excellence and collaboration, Immunocore is positioned at the forefront of therapeutic innovation in the biopharmaceutical industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Edmonton, , Canada
Madrid, , Spain
Boston, Massachusetts, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Leipzig, , Germany
Hackensack, New Jersey, United States
Paris, , France
Jacksonville, Florida, United States
Essen, , Germany
Portland, Oregon, United States
Barcelona, , Spain
Madrid, , Spain
Nashville, Tennessee, United States
Stockholm, , Sweden
Sevilla, , Spain
Los Angeles, California, United States
Dresden, , Germany
Glasgow, , United Kingdom
Buenos Aires, , Argentina
Minden, , Germany
Glasgow, , United Kingdom
Barcelona, , Spain
Hamburg, , Germany
Brussels, , Belgium
Valencia, , Spain
Sevilla, , Spain
Córdoba, , Spain
Barcelona, , Spain
Madrid, , Spain
Aurora, Colorado, United States
Barcelona, , Spain
Oxford, , United Kingdom
Heidelberg, , Australia
Manchester, , United Kingdom
Granada, , Spain
Greenville, South Carolina, United States
Madrid, , Spain
Lake Success, New York, United States
La Jolla, California, United States
Leuven, , Belgium
Gdansk, , Poland
Oslo, , Norway
Milano, , Italy
La Jolla, California, United States
Santa Monica, California, United States
Seville, , Spain
Barcelona, , Spain
Porto Alegre, , Brazil
Nedlands, Western Australia, Australia
New York, New York, United States
San Francisco, California, United States
Valencia, , Spain
São Paulo, , Brazil
Villejuif, , France
Greenslopes, Queensland, Australia
Madrid, , Spain
Tampa, Florida, United States
Pölten, , Austria
Nantes, , France
Malatya, , Turkey
Los Angeles, California, United States
Westwood, California, United States
Aurora, Colorado, United States
Washington, District Of Columbia, United States
Wollstonecraft, , Australia
Woolloongabba, , Australia
St. Poelten, , Austria
Brussels, , Belgium
Leuven, , Belgium
Ijuí, , Brazil
Rio De Janeiro, , Brazil
Rio De Janeiro, , Brazil
Edmonton, , Canada
Toronto, , Canada
Bordeaux, , France
Boulogne Billancourt, , France
Marseille, , France
Paris, , France
Toulouse, , France
Berlin, , Germany
Dresden, , Germany
Essen, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Minden, , Germany
Milano, , Italy
Napoli, , Italy
Siena, , Italy
Guadalajara, , Mexico
Warszawa, , Poland
Cluj Napoca, , Romania
Craiova, , Romania
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Malaga, , Spain
Zürich, , Switzerland
Cambridge, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Northwood, , United Kingdom
Los Angeles, California, United States
Boulogne Billancourt, , France
Villejuif, , France
Heidelberg, , Germany
Napoli, , Italy
Padova, , Italy
Warszawa, , Poland
Zurich, , Switzerland
Viedma, , Argentina
Los Angeles, California, United States
Chicago, Illinois, United States
Seattle, Washington, United States
Caba, Buenos Aires, Argentina
Caba, Buenos Aires, Argentina
North Melbourne, , Australia
Salzburg, , Austria
Panagyurishte, , Bulgaria
Plovdiv, , Bulgaria
Praha, , Czechia
Herlev, , Denmark
Marseille, Cedex, France
Toulouse, Cedex, France
Bobigny, , France
Dijon, , France
Lille, , France
Pierre Benite, , France
Rouen, , France
Valence, , France
Berlin, , Germany
Hamburg, , Germany
Leipzig, , Germany
Tübingen, , Germany
Würzburg, , Germany
Pécs, , Hungary
Bari, , Italy
Meldola, , Italy
Milan, , Italy
Ponderano, , Italy
Siena, , Italy
Bydgoszcz, , Poland
Skorzewo, , Poland
Craiova, , Romania
El Palmar, Murcia, Spain
Barcelona, , Spain
Valencia, , Spain
Göteborg, , Sweden
Uppsala, , Sweden
Cambridge, , United Kingdom
Liverpool, , United Kingdom
Caba, , Argentina
Sofia, , Bulgaria
Surrey Quays, , United Kingdom
Barretos, , Brazil
Florianópolis, , Brazil
Porto Alegre, , Brazil
Sofia, , Bulgaria
Budapest, , Hungary
Bergamo, , Italy
A Coruña, , Spain
Altındağ, , Turkey
Ankara, , Turkey
çankaya, , Turkey
London, , United Kingdom
Pamplona, , Spain
Edgewood, Kentucky, United States
Palo Alto, California, United States
Farmington, Connecticut, United States
Miami, Florida, United States
Charlottesville, Virginia, United States
Waratah, New South Wales, Australia
Nedlands, Western Australia, Australia
Anderlecht, , Belgium
Brugge, , Belgium
Porto Alegre, Rs, Brazil
Brasília, , Brazil
Fortaleza, , Brazil
Liberdade, , Brazil
Rio De Janeiro, , Brazil
Rio De Janeiro, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Hradec Králové, , Czechia
Olomouc, , Czechia
Caen, , France
Erfurt, , Germany
Frankfurt, , Germany
Gießen, , Germany
Munich, , Germany
Szeged, , Hungary
Padova, , Italy
Perugia, , Italy
Roma, , Italy
Bergen, , Norway
Cluj Napoca, , Romania
Santander, Cantabria, Spain
Madrid, , Spain
Jönköping, , Sweden
Lund, , Sweden
çankaya, Ankara, Turkey
Antalya, Campus, Turkey
Bahçelievler, Istanbul, Turkey
Samsun, , Turkey
Seyhan, , Turkey
Yenimahalle, , Turkey
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported