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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02752074 | A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301) | PHASE3 | COMPLETED | 706 | — | — | Jun 21, 2016 | Aug 16, 2019 | Aug 24, 2025 | 129 | United States, Australia +21 |
Progression-free survival, defined as the time from date of randomization until the earliest date of disease progression, as determined by independent central review of objective radiographic disease assessments per RECIST 1.1, or death from any cause, whichever comes first.
Defined as time from date of randomization to date of death due to any cause. OS was calculated using product-limit (Kaplan-Meier) method for censored data.
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab + Epacadostat | EXPERIMENTAL | Pembrolizumab + Epacadostat |
| Pembrolizumab + Placebo | ACTIVE_COMPARATOR | Pembrolizumab + Placebo |
| Name | Type | Description |
|---|---|---|
| pembrolizumab + epacadostat | DRUG | * Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1) * Epacadostat will be administered orally daily starting at Day 1 (Week 1) |
| pembrolizumab + placebo | DRUG | * Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1) * Placebo will be administered orally daily starting at Day 1 (Week 1) |
Inclusion Criteria: * Have histologically or cytologically confirmed melanoma * Have unresectable Stage III or Stage IV melanoma, as per AJCC staging system not amenable to local therapy * A minimum of 1 measurable lesion by CT or MRI * Provide a baseline tumor biopsy * Eastern Cooperative Oncology...