Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06101134 | A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations | PHASE2 | ACTIVE NOT_RECRUITING | 100 | — | — | Nov 6, 2023 | Aug 31, 2027 | Apr 9, 2026 | 31 | United States, Chile +3 |
| NCT03470922 | A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma | PHASE2 | ACTIVE NOT_RECRUITING | 714 | — | — | Apr 11, 2018 | Dec 15, 2030 | Sep 9, 2025 | 127 | United States, Argentina +23 |
PEPQ included 7 items 1. Pain or Discomfort (rated on 1 to 10 scale), 2. Length of time related to administration 3. Length of time related to administration impact amount of time to speak to doctor or nurse about illness or concern 4. Length of time for administration impact time to interact or socialize with other individuals 5. Convenience 6. Satisfaction 7. Choice of which route of administration would be preferred. 95% CI exact confidence interval was reported.
Progression Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented tumor progression, assessed by a blinded independent central review (BICR) (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Metastatic Melanoma | EXPERIMENTAL | - |
| Cohort 2: Resected Melanoma | EXPERIMENTAL | - |
| Arm A: Relatlimab + Nivolumab | EXPERIMENTAL | Combination |
| Arm B: Nivolumab | EXPERIMENTAL | Monotherapy |
| Name | Type | Description |
|---|---|---|
| relatlimab+nivolumab | DRUG | Specified dose on specified days |
| relatlimab+nivolumab+rHuPH20 | DRUG | Specified dose on specified days |
| nivolumab | DRUG | Specified dose on specified days |
| nivolumab+rHuPH20 | DRUG | Specified dose on specified days |
| Relatlimab | BIOLOGICAL | Specified dose on specified day |
Inclusion Criteria: * Must have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease * Must have a low level of disa...