Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fianlimab · 8 trials · 7 indications
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)
ORR is defined as confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST 1.1.
Phase 2 ORR is defined as proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR).
Phase 3 Defined as the time from randomization to the date of death due to any cause
Proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR)
| 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 |
| Arm A: Cemiplimab, Fianlimab, and Ipilimumab | EXPERIMENTAL | Cemiplimab and fianlimab will be co-administered by IV. Ipilimumab will be administered by IV. |
| Arm B: Cemiplimab and Fianlimab | EXPERIMENTAL | Cemiplimab and fianlimab will be co-administered by IV. |
| Arm C: Nivolumab and Ipilimumab | ACTIVE_COMPARATOR | Nivolumab and ipilimumab will be by IV. Nivolumab will be administered by IV after the combination. |
| With Disease Progression at Enrollment | OTHER | - |
| No Progressive Disease at Enrollment | OTHER | - |
| Arm A | EXPERIMENTAL | Randomized 1:1:1 Neoadjuvant period: placebo + cemiplimab + platinum doublet chemotherapy Adjuvant period: placebo + cemiplimab |
| Arm B | EXPERIMENTAL | Randomized 1:1:1 Neoadjuvant period: fianlimab high dose + cemiplimab + platinum doublet chemotherapy Adjuvant period: fianlimab high dose + cemiplimab |
| Arm C | EXPERIMENTAL | Randomized 1:1:1 Neoadjuvant period: fianlimab low dose + cemiplimab + platinum doublet chemotherapy Adjuvant Period: fianlimab low dose + cemiplimab |
| Phase 2 - Arm A | EXPERIMENTAL | Randomized 1:1:1 fianlimab (higher dose) + cemiplimab + platinum-doublet chemotherapy |
| Phase 2 - Arm B | EXPERIMENTAL | Randomized 1:1:1 fianlimab (lower dose) + cemiplimab + platinum-doublet chemotherapy |
| Phase 2 - Arm C | EXPERIMENTAL | Randomized 1:1:1 cemiplimab + platinum-doublet chemotherapy + placebo |
| Phase 3 - Arm A or B | EXPERIMENTAL | Randomized 1:1 fianlimab (chosen dose) + cemiplimab + platinum-doublet chemotherapy |
| Phase 3 - Arm C | EXPERIMENTAL | Randomized 1:1 cemiplimab + platinum-doublet chemotherapy + placebo |
| A: fianlimab+cemiplimab | EXPERIMENTAL | Phase 2: fianlimab (HD) |
| B: fianlimab+cemiplimab | EXPERIMENTAL | Phase 2: fianlimab (LD) |
| C: cemiplimab monotherapy+placebo | EXPERIMENTAL | Phase 2 |
| 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 |
| Ipilimumab | DRUG | Ipilimumab will be administered by IV. |
| Nivolumab | DRUG | Nivolumab will be administered by IV. Maintenance nivolumab will then be administered by IV. |
| Fianlimab+cemiplimab | DRUG | No study drug administered in this observational study. |
| Pemetrexed | DRUG | Administered IV Q3W |
| Paclitaxel | DRUG | Administered IV Q3W |
| Carboplatin | DRUG | Administered IV Q3W |
| Cisplatin | DRUG | Administered IV Q3W |
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...
Top 20 of 52 competitors