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Adjuvant Immunotherapy with Nivolumab + Relatlimab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma
EU CTIS ID: 2023-507688-20-00
What this study is testing
To compare the efficacy, as measured by RFS, provided by nivo + rela FDC vs nivolumab monotherapy in participants with completely resected Stage III/IV NED melanoma.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- All participants must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by AJCC v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible. All melanomas, except ocular melanoma, regardless of primary site of disease, will be allowed. Note: Conjunctival melanoma is not considered to be ocular melanoma and is to be classified as mucosal melanoma.
- All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization.
- Tumor tissue obtained from surgical specimen or biopsy during resection collected within 90 days prior to randomization, with an associated pathology report, must be submitted to the central laboratory (preferably prior to randomization).
- Participant must be ≥ 12 years of age inclusive at the time of signing the informed consent. Except: Where local regulations and/or institutional policies do not allow for participants < 18 years of age (adolescent population) to participate. For those sites, the eligible participant population is ≥ 18 years of age.
- Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. Adolescent participants between 12 and <18 years of age must have a Lansky/Karnofsky performance score ≥ 80%.
You likely can't join if
- Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted (such as, but not limited to, antiprogrammed death-1 (anti-PD-1), anti-programmed death ligand-1 (anti-PD-L1), anti-programmed death ligand-2 (PD-L2), or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways).
- Prior treatment with LAG-3 targeted agents
- Prior therapy for melanoma except surgery for the melanoma lesion(s) and/or adjuvant radiation therapy for central nervous system lesions.
- Participants with an active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Participants with a history of myocarditis, regardless of etiology.
- Prior treatment with BRAF/MEK targeted agents.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- China
- Australia
- Chile
- Israel
- Mexico
- Canada
- Brazil
- Switzerland
- Argentina
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; China; Australia; Chile; Israel; Mexico and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.