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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03815058 | A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma. | PHASE2 | COMPLETED | 131 | — | — | Dec 21, 2018 | Jan 21, 2025 | Jan 30, 2026 | 41 | United States, Australia +4 |
PFS was defined as the time from randomization to the first documented PD as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Kaplan-Meier (KM) method was used to estimate median PFS.
| Arm | Type | Description |
|---|---|---|
| Safety Run-in Period: Autogene Cevumeran + Pembrolizumab | EXPERIMENTAL | Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by intravenous (IV) infusion followed by 200 mg pembrolizumab IV infusion every 3 weeks (Q3W) plus a recommended dose of autogene cevumeran. |
| Randomized Period: Arm A: Pembrolizumab | ACTIVE_COMPARATOR | Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W. Participants in Arm A have the option to cross over to combination treatment with autogene cevumeran plus pembrolizumab (Arm B) after confirmed disease progression. |
| Randomized Period: Arm B: Autogene Cevumeran + Pembrolizumab | EXPERIMENTAL | Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by IV infusion followed by 200 mg pembrolizumab IV infusion Q3W plus a recommended dose of autogene cevumeran. |
| Name | Type | Description |
|---|---|---|
| Autogene cevumeran | BIOLOGICAL | Participants will receive a recommended dose of autogene cevumeran administered by IV infusion at protocol-defined intervals. |
| Pembrolizumab | DRUG | Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W. |
Inclusion Criteria: * Histologically confirmed metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage IIIC or IIID) cutaneous, acral, or mucosal melanoma; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; * Life expectancy \>/= 12 weeks; * Adequat...