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Recruiting Phase 3

IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

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About this study

This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A\*02:01-positive participants with previously untreated advanced melanoma.

Condition
Advanced Melanoma
Tested
Brenetafusp, Nivolumab, Nivolumab + Relatlimab
Sponsor
Immunocore Ltd

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 9

  • Minimum age: 18 years
  • Study condition: Advanced Melanoma
  • 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 9

  • 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

Where

211 sites, 201 recruiting

Hospital Italiano de Buenos Aires (HIBA)

Buenos Aires, Argentina

Recruiting

Sanatorio Finochietto

Caba, Buenos Aires, Argentina

Recruiting

Clínica Adventista Belgrano - Sector Investigación

Caba, Buenos Aires, Argentina

Recruiting

Instituto Alexander Fleming

CABA, Argentina

Recruiting

CEMAIC (Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, Argentina

Recruiting

Clinica Viedma

Viedma, Argentina

Recruiting

and 205 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.