Trial · NCT02419417
Study of BMS-986158 in Subjects With Select Advanced Cancers
NCT02419417, Phase 1, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2022-06-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of BMS-986158 in Subjects With Select Advanced Cancers. Trials, record NCT02419417. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02419417
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of BMS-986158 in Subjects With Select Advanced Cancers
- NCT number
- NCT02419417
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 83 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Advanced Tumors
- Interventions
- BMS-986158, Nivolumab
- First posted
- 2015-04-17
- Last updated
- 2022-06-16
- Other registries' IDs
- eudract:2015-000324-29
- Results first posted
- 2022-06-16
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing Adverse Events | From first dose to 30 days following last dose (up to approximately 29 months) | Number of participants experiencing different types of events, including Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation and deaths. Events are classified based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. |
| Primary | Number of Participants With Abnormal Hepatic Test Values | From first dose to 30 days following last dose (up to approximately 29 months) | Number of participants experiencing abnormal hepatic function, as measured by different parameters. ALT = Alanine aminotransferase AST = Aspartate aminotransferase ULN = Upper Limit of Normal |
| Secondary | Best Overall Response (BOR) | From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months) | BOR, as assessed by the investigator, is defined as the best response designation, recorded between the dates of first dose and the date of first objectively documented progression (per RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies or PCWG3 for prostate cancer) or the date of subsequent therapy, whichever occurs first. |
| Secondary | Objective Response Rate (ORR) | From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months) | ORR is defined as the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) |
| Secondary | Duration of Response (DOR) | From date of first response to date of first objectively documented disease progression or death (up to approximately 42 weeks) | DOR is defined as the time between the date of first response and the date of the first objectively documented disease progression (as determined by RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies, or PCWG3 (including PSA assessments) for prostate cancer \[CRPC or NEPC\]), or death due to any cause, whichever occurs first. |
| Secondary | Progression Free Survival (PFS) | From first dose to date of first objectively documented disease progression or death (up to approximately 28 months) | PFS is defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause. |
| Secondary | Progression Free Survival Rate (PFSR) | From first dose to 12 weeks, to 24 weeks, and to 48 weeks after first dose | PFSR is defined as the percentage of participants who remain progression free and surviving at the specified timepoints (12 weeks, 24 weeks, and 48 weeks). Reported values are estimates derived from Kaplan-Meier analyses |
| Secondary | Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485 |
| Secondary | Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485 |
| Secondary | Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing Adverse Events | From first dose to 30 days following last dose (up to approximately 29 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Hepatic Test Values | From first dose to 30 days following last dose (up to approximately 29 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Best Overall Response (BOR) | From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months) | All treated participants | Percent of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From date of first response to date of first objectively documented disease progression or death (up to approximately 42 weeks) | All participants who achieved a Complete Response (CR) or Partial Response (PR) | Weeks | MEAN |
| SECONDARY | Progression Free Survival (PFS) | From first dose to date of first objectively documented disease progression or death (up to approximately 28 months) | All treated participants. | Weeks | MEDIAN |
| SECONDARY | Progression Free Survival Rate (PFSR) | From first dose to 12 weeks, to 24 weeks, and to 48 weeks after first dose | All treated participants. | Percent of participants | NUMBER |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | All treated participants with available measurements | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | All treated participants with available measurements | Hours | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | All treated participants with available measurements | hr*ng/mL | GEOMETRIC_MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group691
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experiencing Adverse Events | Part 1 Schedule A - BMS-986158 0.75 mg | Adverse Events (AEs) | 5 | Participants | |
| Number of Participants Experiencing Adverse Events | Part 1 Schedule A - BMS-986158 1.25 mg | Adverse Events (AEs) | 4 | Participants | |
| Number of Participants Experiencing Adverse Events | Part 1 Schedule A - BMS-986158 2 mg | Adverse Events (AEs) | 13 | Participants | |
| Number of Participants Experiencing Adverse Events | Part 1 Schedule A - BMS-986158 3 mg | Adverse Events (AEs) | 10 | Participants | |
| Number of Participants Experiencing Adverse Events | Part 1 Schedule A - BMS-986158 4.5 mg | Adverse Events (AEs) | 13 | Participants | |
| Number of Participants Experiencing Adverse Events | Part 1 Schedule B - BMS-986158 2 mg | Adverse Events (AEs) | 4 | Participants | |
| Number of Participants Experiencing Adverse Events | Part 1 Schedule B - BMS-986158 3 mg | Adverse Events (AEs) | 4 | Participants | |
| Number of Participants Experiencing Adverse Events | Part 1 Schedule C - BMS-986158 2 mg | Adverse Events (AEs) | 6 | Participants | |
| Number of Participants Experiencing Adverse Events | Part 1 Schedule C - BMS-986158 3 mg | Adverse Events (AEs) | 13 | Participants | |
| Number of Participants Experiencing Adverse Events | Part 1 Schedule C - BMS-986158 4.5 mg | Adverse Events (AEs) | 9 | Participants |
1 to 10 of 691Source ClinicalTrials.gov
See all 691 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1 Schedule A - BMS-986158 0.75 mg | 5 | |
| Overall Study | STARTED | Part 1 Schedule A - BMS-986158 1.25 mg | 4 | |
| Overall Study | STARTED | Part 1 Schedule A - BMS-986158 2 mg | 13 | |
| Overall Study | STARTED | Part 1 Schedule A - BMS-986158 3 mg | 10 | |
| Overall Study | STARTED | Part 1 Schedule A - BMS-986158 4.5 mg | 13 | |
| Overall Study | STARTED | Part 1 Schedule B - BMS-986158 2 mg | 4 | |
| Overall Study | STARTED | Part 1 Schedule B - BMS-986158 3 mg | 4 | |
| Overall Study | STARTED | Part 1 Schedule C - BMS-986158 2 mg | 6 | |
| Overall Study | STARTED | Part 1 Schedule C - BMS-986158 3 mg | 13 | |
| Overall Study | STARTED | Part 1 Schedule C - BMS-986158 4.5 mg | 10 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events2,398
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Schedule A - BMS-986158 0.75 mg | 0 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Schedule A - BMS-986158 1.25 mg | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Schedule A - BMS-986158 2 mg | 4 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Schedule A - BMS-986158 3 mg | 1 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Schedule A - BMS-986158 4.5 mg | 9 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Schedule B - BMS-986158 2 mg | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Schedule B - BMS-986158 3 mg | 2 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Schedule C - BMS-986158 2 mg | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Schedule C - BMS-986158 3 mg | 4 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Schedule C - BMS-986158 4.5 mg | 3 | 10 |
1 to 10 of 2,398Source ClinicalTrials.gov
See all 2,398 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1 Schedule A - BMS-986158 0.75 mg | 5 | 5 |
| Total, all-cause mortality | Part 1 Schedule A - BMS-986158 1.25 mg | 3 | 4 |
| Total, all-cause mortality | Part 1 Schedule A - BMS-986158 2 mg | 10 | 13 |
| Total, all-cause mortality | Part 1 Schedule A - BMS-986158 3 mg | 8 | 10 |
| Total, all-cause mortality | Part 1 Schedule A - BMS-986158 4.5 mg | 12 | 13 |
| Total, all-cause mortality | Part 1 Schedule B - BMS-986158 2 mg | 3 | 4 |
| Total, all-cause mortality | Part 1 Schedule B - BMS-986158 3 mg | 3 | 4 |
| Total, all-cause mortality | Part 1 Schedule C - BMS-986158 2 mg | 4 | 6 |
| Total, all-cause mortality | Part 1 Schedule C - BMS-986158 3 mg | 10 | 13 |
| Total, all-cause mortality | Part 1 Schedule C - BMS-986158 4.5 mg | 7 | 10 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02419417
GET https://conductscience.org/api/trials/v1/NCT02419417/registered?page=2