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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04526899 | A Study to Investigate the Novel Agent BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Advanced Melanoma That Has Not Responded to Other Forms of Treatment | PHASE2 | COMPLETED | 184 | — | — | May 19, 2021 | Nov 24, 2025 | Jan 8, 2026 | 49 | United States, Australia +5 |
ORR was defined as the percentage of participants in whom a complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) was observed as best overall response by blinded independent central review (BICR). Per RECIST 1.1 criteria, CR defined as the disappearance of all target lesions and PR was defined as the \>=30% decrease in the sum of the longest diameter of target lesions.
| Arm | Type | Description |
|---|---|---|
| BNT111 + cemiplimab | EXPERIMENTAL | - |
| BNT111 monotherapy | EXPERIMENTAL | - |
| Cemiplimab monotherapy | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BNT111 | BIOLOGICAL | IV injection |
| Cemiplimab | BIOLOGICAL | IV infusion |
Inclusion Criteria: * Patients must sign the written informed consent form (ICF) before any screening procedure. * Patients must be aged \>=18 years on the date of signing the informed consent. * Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests...