Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nivolumab · 1 trial · 1 indication
Depth of response will be determined for each participant post ide-cel with adjuvant nivolumab indicating if their best overall response is a Complete Response (CR) or stringent Complete Response (sCR). The post-ide-cel disease response assessments will be calculated relative to the participant's pre-ide-cel disease assessment parameters. Responses will be determined per IMWG 2016 response criteria.
| Arm | Type | Description |
|---|---|---|
| Single Arm | EXPERIMENTAL | Nivolumab |
| Name | Type | Description |
|---|---|---|
| Nivolumab | DRUG | 2 cycles of nivolumab at a dose of 480 mg given over approximately 30-minutes intravenously on Day 1 of each treatment cycle |
Inclusion Criteria: 1. Written informed consent and HIPAA authorization for release of personal health information signed by the participant or his/her legally authorized representative 2. Age ≥ 18 years at the time of consent 3. ECOG Performance Status (PS) of ≤ 1 at the time of enrollment. PS mus...
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