| Title |
A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma |
| Protocole ID |
RELATIVITY-127 (CA224-127) |
| ClinicalTrials.gov ID |
NCT05625399 |
| Cancer Type(s) |
Melanoma |
| Phase |
Phase III |
| Stage |
|
| Study Type |
Clinical |
| Drug |
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| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 HOPITAL DE L'ENFANT-JESUS
1401 18e Rue, Québec, QC, G1J 1Z4
|
| City |
|
| Principal Investigator |
Dr. Félix Couture
|
| Coordinator |
Maryse Gingras
418-691-5781
|
| Status |
Recruiting |
| Activation Date |
15-05-2023 |
| Eligibility Criteria |
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of age).
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system.
- Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and < 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent).
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).
|
| Exclusion Criteria |
- Participants must not have ocular melanoma.
- Participants must not have a history of myocarditis, regardless of etiology.
- Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
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Groupe d'étude en oncologie du Québec