Study Comparing IMC-F106C and Nivolumab Treatments in Patients with Advanced Melanoma

Sponsor: Immunocore Ltd

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06112314

This clinical trial is testing a new treatment, IMC-F106C combined with nivolumab, against the standard nivolumab treatment in patients with advanced melanoma who have not received prior treatment.

Patient Parameters

Program Overview

The purpose of this study is to compare the effectiveness of a new treatment combination, IMC-F106C plus nivolumab, with the standard nivolumab treatment in patients who have advanced melanoma and have not been treated before. The study focuses on patients who are HLA-A*02:01-positive, a specific genetic marker.

Eligibility Criteria

Inclusion Criteria

  • Must have a specific genetic marker called HLA-A*02:01.
  • Must have been diagnosed with advanced melanoma that is either Stage IV or cannot be surgically removed at Stage III.
  • Must provide a tumor sample that is suitable for testing.
  • Must have measurable cancer according to standard criteria.
  • Must have the BRAF V600 mutation status checked.
  • Must be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • If of childbearing potential and sexually active, must agree to use effective birth control during the study and for 5 months after the last treatment.

Exclusion Criteria

  • Have a history of other cancers not being treated in this study.
  • Have untreated or active cancer spread to the brain or spinal cord.
  • Have allergies to the study drugs or their ingredients.
  • Have significant lung or heart disease.
  • Have an active autoimmune disease requiring treatment that suppresses the immune system.
  • Have any poorly controlled medical condition that could affect participation in the study.
  • Have received previous treatment for melanoma that cannot be removed or has spread.
  • Have had a severe reaction to previous treatments targeting PD-(L)1 or LAG-3.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.