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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02983006 | Study of DS-8273a With Nivolumab in Unresectable Stage III or Stage IV Melanoma | PHASE1 | COMPLETED | 12 | — | — | Oct 1, 2016 | Jan 1, 2021 | Oct 18, 2021 | 1 | United States |
Safety will be evaluated for all treated subjects using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
| Arm | Type | Description |
|---|---|---|
| DS-8273a & Nivolumab | EXPERIMENTAL | Patient groups (cohorts) will receive a single dose level of DS 8273a \& Nivolumab; DS 8273a will be increased in subsequent cohorts. |
| Name | Type | Description |
|---|---|---|
| DS-8273a | BIOLOGICAL | * Starting Dose: 4 mg/ kg IVQ 3 weeks (Cohort 1) * Dose Escalation: 8 mg/kg IV Q 3 weeks (Cohort 2), 16 mg/kg IV Q 3 weeks (Cohort 3), 24 mg/kg IV Q 3 weeks (Cohort 4), 2 mg/kg IV Q 3 weeks (Cohort -1), 4 mg/kg IV Q 3 weeks (Cohort -2) |
| Nivolumab | BIOLOGICAL | 5 mg/kg IV Q 3 weeks |
Inclusion Criteria: * 1\) Signed Written Informed Consent The signed informed consent form prior to the performance of any study related procedures that are not considered part of standard of care. 2\) Target Population 1. Subjects who are ipilimumab naïve with progressive unresectable Stage I...