Trial · NCT03446040
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) | From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks) | All treated participants. Participants who started in the Part A1 group but transitioned to Part B are accounted for in both treatment groups. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Died During the Study | From first dose until death due to any cause (up to approximately 78 months) | All treated participants. Participants who crossed over from part A1 are accounted for under their original arm assignment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Dose Limiting Toxicities (DLTs) | From first dose (Cycle 1 Day 1) until day 28 (Cycle 1 Day 28) | All treated participants who were evaluable for DLTs. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | From first dose until disease progression or death, whichever occurred first (up to approximately 78 months) | All treated participants. Prespecified to be reported collectively per Part. Participants who crossed over from part A1 to Part B are accounted for in both arms. | Percent of Participants | NUMBER |
| SECONDARY | Median Duration of Response (mDOR) | From first dose until disease progression or death whichever occurred first (up to approximately 78 months) | All treated participants witha complete or partial response. Prespecified to be reported collectively per Part. Response evaluable participants who crossed over from part A1 to Part B are accounted for in both arms. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) Rate at 6, 9, and 12 Months | At 6, 9, and 12 months after first dose | All treated participants. Prespecified to be reported collectively per Part. Treated participants who crossed over from part A1 to Part B are accounted for in both arms. | Percent of Participants | NUMBER |
| SECONDARY | Maximum Plasma Concentration (Cmax) of BMS-986258 | Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks) | All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258 | Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks) | All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms. | h*ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258 | Part A and B: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks) | All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms. | h*ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Concentration at the End of the Dosing Interval (Ctau) of BMS-986258 | Part A and B: On Cycle 1 Day 29 and Cycle 3 Day 29 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 29 and Cycle 2 Day 1 predose (1 cycle = 8 weeks) | All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Maximum Concentration (Tmax) of BMS-986258 | Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks) | All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms. | Hours | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Anti-Drug Antibodies to BMS-986258 or Nivolumab | From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks) | All treated participants with baseline and at least one post-baseline pre-infusion ADA assessment. Prespecified to be reported collectively per Part. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03446040/outcomes