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
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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.
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