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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06246916 | A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head) | PHASE3 | RECRUITING | 560 | — | — | Sep 9, 2024 | Jul 10, 2033 | May 6, 2026 | 109 | United States, Canada |
| NCT05608291 | A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery | PHASE3 | ACTIVE NOT_RECRUITING | 1,564 | — | — | Jan 16, 2023 | Feb 15, 2030 | May 13, 2025 | 211 | United States, Argentina +20 |
| NCT05352672 | Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma | PHASE3 | ACTIVE NOT_RECRUITING | 1,546 | — | — | Jul 14, 2022 | Sep 16, 2031 | Apr 22, 2026 | 210 | United States, Argentina +22 |
| NCT06848088 | A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment | PHASE2 | ENROLLING BY_INVITATION | 48 | — | — | Apr 14, 2025 | Oct 10, 2029 | Jan 12, 2026 | 8 | United States, Ireland |
Time from randomization to the first documented recurrence of disease at any site (excluding new primary melanomas) or death from any cause, whichever occurs first.
Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Blinded Independent Central Review (BICR)
| Arm | Type | Description |
|---|---|---|
| fianlimab+cemiplimab | EXPERIMENTAL | Randomized 1:1 |
| relatlimab+nivolumab | ACTIVE_COMPARATOR | Randomized 1:1 |
| Fianlimab HD + Cemiplimab | EXPERIMENTAL | Patients will be administered one combination dose of fianlimab high dose (HD) and cemiplimab |
| Fianlimab LD + Cemiplimab | EXPERIMENTAL | Patients will be administered one combination dose of fianlimab low dose (LD) and cemiplimab |
| Pembrolizumab | ACTIVE_COMPARATOR | Patients will be administered one dose of pembrolizumab co-infused with saline/dextrose placebo |
| A: fianlimab+cemiplimab dose 1 | EXPERIMENTAL | As defined in Protocol Amendment 5 |
| A1: fianlimab+cemiplimab dose 2 | EXPERIMENTAL | As defined in Protocol Amendment 5 |
| B: pembrolizumab+placebo | EXPERIMENTAL | As defined in Protocol Amendment 5 |
| C: cemiplimab+placebo | EXPERIMENTAL | As defined in Protocol Amendment 5 |
| With Disease Progression at Enrollment | OTHER | - |
| No Progressive Disease at Enrollment | OTHER | - |
| Name | Type | Description |
|---|---|---|
| fianlimab | DRUG | Intravenous (IV) administration every 3 weeks (Q3W) in combination with cemiplimab |
| cemiplimab | DRUG | IV administration Q3W in combination with fianlimab |
| relatlimab+nivolumab | DRUG | IV administration every 4 weeks (Q4W) |
| Pembrolizumab | DRUG | Pembrolizumab will be administered by IV infusion Q 3 weeks |
| Placebo | DRUG | Matching placebo co-infused with pembrolizumab IV, will be administered by IV infusion Q 3 weeks |
| Fianlimab+cemiplimab | DRUG | No study drug administered in this observational study. |
Key Inclusion Criteria: 1. Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition. 2. Participants must not have received prior systemic therapy for unresectable or metastatic melanom...