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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03329846 | An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma | PHASE3 | COMPLETED | 20 | — | — | Nov 30, 2017 | Jul 2, 2020 | Jul 9, 2021 | 63 | United States, Australia +14 |
Number of participants experiencing different types of Adverse Events, including Death, Any cause Adverse Events (AEs), Drug-related AEs, Any cause Serious Adverse Events (SAEs), Drug-related SAEs, SAEs leading to discontinuation, and Drug-related Non-serious AEs leading to discontinuation
| Arm | Type | Description |
|---|---|---|
| Nivolumab + Placebo | ACTIVE_COMPARATOR | Specified dose on specified day Participants will no longer receive BMS-986205 Placebo |
| Nivolumab + BMS-986205 | EXPERIMENTAL | Specified dose on specified day. Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion |
| Name | Type | Description |
|---|---|---|
| BMS-986205 | DRUG | specified dose on specified day |
| Nivolumab | BIOLOGICAL | Specified dose on specified day |
| Placebo | DRUG | Specified dose on specified day |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * 12 years and older unless not permitted by local regulations; in that case 18 years old and older * Eastern Cooperative Oncology Group (ECOG) performance sta...