Trial · NCT02598960
An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.
NCT02598960, Phase 1, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2023-03-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread. Trials, record NCT02598960. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02598960
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.
- NCT number
- NCT02598960
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 295 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Solid Tumors
- Interventions
- BMS-986156, Nivolumab
- First posted
- 2015-11-06
- Last updated
- 2023-03-06
- Other registries' IDs
- eudract:2015-002505-11
- Results first posted
- 2023-03-06
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | From first treatment to 100 days post last dose. Approximately 29 months | Number of participants with all cause adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and number of participant deaths. AEs and laboratory values will be graded according to the NCI CTCAE version 4.03. |
| Primary | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | From first treatment to 100 days post last dose. Approximately 29 months | Number of Participants with laboratory abnormalities in specific thyroid tests. TSH = Thyroid stimulating hormone ULN = Upper limit number LLN = Lower limit number |
| Primary | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | From first treatment to 100 days post last dose. Approximately 29 months | Number of Participants with laboratory abnormalities in specific liver tests. ALT = alanine aminotransferase AST = aspartate aminotransferase ALP = alkaline phosphatase |
| Secondary | Best Overall Response | From first dose to a response or progressive disease (Approximately 50 Months) | BOR will be defined by CR, PR, PD and SD Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Overall Response Rate | From first dose to CR and PR (Approximately 50 Months) | Defined as the percentage of all treated participants whose BOR is either a complete response(CR) or partial response(PR). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Progression Free Survival (PFS) | From first dose to disease progression (Approximately 50 Months) | The time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Secondary | Duration of Response | From first dose to disease progression after a response (Approximately 50 Months) | All treated participants with a BOR of CR or PR, is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Number of Participants With Anti-Drug Antibody Response | At Cycle 3 Day 1; where each treatment cycle was 8 weeks | Number of participants with a positive Anti-Drug Antibody to BMS-986156 or nivolumab |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | From first treatment to 100 days post last dose. Approximately 29 months | All Treated Participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | From first treatment to 100 days post last dose. Approximately 29 months | All treated participants with at least one on - treatment TSH measurement | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | From first treatment to 100 days post last dose. Approximately 29 months | All treated participants with at least one on - treatment liver test measurement | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Best Overall Response | From first dose to a response or progressive disease (Approximately 50 Months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate | From first dose to CR and PR (Approximately 50 Months) | All treated participants | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | From first dose to disease progression (Approximately 50 Months) | All treated participants with evaluable PFS measures | Months | MEDIAN |
| SECONDARY | Duration of Response | From first dose to disease progression after a response (Approximately 50 Months) | All treated participants with a CR or PR | Months | MEDIAN |
| SECONDARY | Number of Participants With Anti-Drug Antibody Response | At Cycle 3 Day 1; where each treatment cycle was 8 weeks | All BMS-986156 or Nivolumab Treated participants with Baseline and at Least One Post-baseline Assessment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group363
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Part A: BMS-986156 10mg | Adverse Events (AEs) | 4 | Participants | |
| Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Part A: BMS-986156 30mg | Adverse Events (AEs) | 6 | Participants | |
| Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Part A: BMS-986156 100mg | Adverse Events (AEs) | 4 | Participants | |
| Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Part A: BMS-986156 240mg | Adverse Events (AEs) | 6 | Participants | |
| Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Part A: BMS-986156 800mg | Adverse Events (AEs) | 9 | Participants | |
| Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Part C: BMS-986156 240mg | Adverse Events (AEs) | 3 | Participants | |
| Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Part C: BMS-986156 800mg | Adverse Events (AEs) | 2 | Participants | |
| Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Part B: BMS-986156 30mg + Nivo 240mg | Adverse Events (AEs) | 3 | Participants | |
| Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Part B: BMS-986156 100mg + Nivo 240mg | Adverse Events (AEs) | 9 | Participants | |
| Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Part B: BMS-986156 240mg + Nivo 240mg | Adverse Events (AEs) | 14 | Participants |
1 to 10 of 363Source ClinicalTrials.gov
See all 363 results by groupParticipant flow78
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Part A: BMS-986156 10mg | 4 | |
| Treatment Period | STARTED | Part A: BMS-986156 30mg | 6 | |
| Treatment Period | STARTED | Part A: BMS-986156 100mg | 4 | |
| Treatment Period | STARTED | Part A: BMS-986156 240mg | 6 | |
| Treatment Period | STARTED | Part A: BMS-986156 800mg | 9 | |
| Treatment Period | STARTED | Part C: BMS-986156 240mg | 3 | |
| Treatment Period | STARTED | Part C: BMS-986156 800mg | 2 | |
| Treatment Period | STARTED | Part B: BMS-986156 30mg + Nivo 240mg | 3 | |
| Treatment Period | STARTED | Part B: BMS-986156 100mg + Nivo 240mg | 9 | |
| Treatment Period | STARTED | Part B: BMS-986156 240mg + Nivo 240mg | 14 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 participant flowAdverse events4,108
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 A: BMS-986156 10mg | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: BMS-986156 30mg | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: BMS-986156 100mg | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: BMS-986156 240mg | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: BMS-986156 800mg | 1 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Part C: BMS-986156 240mg | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part C: BMS-986156 800mg | 0 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: BMS-986156 30mg +Nivo 240mg | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: BMS-986156 100mg +Nivo 240mg | 0 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: BMS-986156 240mg +Nivo 240mg | 3 | 14 |
1 to 10 of 4,108Source ClinicalTrials.gov
See all 4,108 adverse eventsAdverse event totals39
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: BMS-986156 10mg | 4 | 4 |
| Total, all-cause mortality | Part A: BMS-986156 30mg | 5 | 6 |
| Total, all-cause mortality | Part A: BMS-986156 100mg | 3 | 4 |
| Total, all-cause mortality | Part A: BMS-986156 240mg | 5 | 6 |
| Total, all-cause mortality | Part A: BMS-986156 800mg | 6 | 9 |
| Total, all-cause mortality | Part C: BMS-986156 240mg | 2 | 3 |
| Total, all-cause mortality | Part C: BMS-986156 800mg | 2 | 2 |
| Total, all-cause mortality | Part B: BMS-986156 30mg +Nivo 240mg | 3 | 3 |
| Total, all-cause mortality | Part B: BMS-986156 100mg +Nivo 240mg | 6 | 9 |
| Total, all-cause mortality | Part B: BMS-986156 240mg +Nivo 240mg | 11 | 14 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT02598960
GET https://conductscience.org/api/trials/v1/NCT02598960/results?page=2