Trial · NCT02737475
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Participants With Solid Cancers That Are Advanced or Have Spread
NCT02737475, Phase 1, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2022-01-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Investigational Immuno-Therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Participants With Solid Cancers That Are Advanced or Have Spread. Trials, record NCT02737475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02737475
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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-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Participants With Solid Cancers That Are Advanced or Have Spread
- NCT number
- NCT02737475
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 166 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Advanced Cancer
- Interventions
- BMS-986178, Nivolumab, Ipilimumab, Tetanus vaccine, DPV-001 vaccine, Cyclophosphamide
- First posted
- 2016-04-14
- Last updated
- 2022-01-25
- Other registries' IDs
- eudract:2015-004816-39
- Results first posted
- 2022-01-25
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | From first dose to 28 days after first dose | The number of participants experiencing dose-limiting toxicities (DLTs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. DLTs are defined based on the incidence, severity, and duration of adverse events (AEs) for which no clear alternative cause is identified. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. |
| Primary | The Number of Participants Experiencing Adverse Events (AEs) | From first dose to 100 days after last dose (up to approximately 2.5 years) | The number of participants experiencing adverse events (AEs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. |
| Primary | The Number of Participants Experiencing Serious Adverse Events (SAEs) | From first dose to 100 days after last dose (up to approximately 2.5 years) | The number of participants experiencing serious adverse events (SAEs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or is an important medical event. |
| Primary | The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | From first dose to 100 days after last dose (up to approximately 2.5 years) | The number of participants experiencing adverse events (AEs) leading to discontinuation of study drug to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. |
| Primary | The Number of Participant Deaths | From first dose to study completion (up to approximately 4 years 5 months) | The number of deaths in each arm to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. |
| Primary | The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology) | From baseline to 100 days after last dose (up to approximately 2.5 years) | The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time |
| Primary | The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION) | From baseline to 100 days after last dose (up to approximately 2.5 years) | The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time |
| Primary | The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING ) | From baseline to 100 days after last dose (up to approximately 2.5 years) | The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time |
| Secondary | Objective Response Rate (ORR) | From baseline up to approximately 2.5 years | The total number of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR) based on assessment of tumor response using RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Overall Response (OR) = CR + PR Baseline is defined as the last non-missing measurement prior to the first dosing date and time. |
| Secondary | Duration of Response (DOR) | From baseline up to approximately 2.5 years | The time between the date of first response and the subsequent date of disease progression or death (death after re-treatment will not be considered), whichever occurs first in participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Best overall response (BOR) is assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Baseline is defined as the last non-missing measurement prior to the first dosing date and time. Due to high percentage of censored response, median estimate may be misleading |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | From first dose to 28 days after first dose | All treated participants (Parts 1-9) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Participants Experiencing Adverse Events (AEs) | From first dose to 100 days after last dose (up to approximately 2.5 years) | All treated participants (Parts 1-9) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Participants Experiencing Serious Adverse Events (SAEs) | From first dose to 100 days after last dose (up to approximately 2.5 years) | All treated participants (Parts 1-9) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | From first dose to 100 days after last dose (up to approximately 2.5 years) | All treated participants (Parts 1-9) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Participant Deaths | From first dose to study completion (up to approximately 4 years 5 months) | All treated participants (Parts 1-9) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology) | From baseline to 100 days after last dose (up to approximately 2.5 years) | All treated participants with on-treatment laboratory results and CTC grade criteria available (Parts 1-9) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION) | From baseline to 100 days after last dose (up to approximately 2.5 years) | All treated participants with on-treatment laboratory results and CTC grade criteria available (Parts 1-9) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING ) | From baseline to 100 days after last dose (up to approximately 2.5 years) | All treated participants with on-treatment laboratory results and CTC grade criteria available (Parts 1-9) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | From baseline up to approximately 2.5 years | Response Evaluable Participants (Parts 1-9) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) | From baseline up to approximately 2.5 years | The number of responders within each tumor type was not sufficient for analysis. (Parts 1-8) | Weeks | MEDIAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group2,200
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Escalation Part 1: BMS 20 mg Q2W | 0 | Participants | ||
| The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Escalation Part 1: BMS 40 mg Q2W | 0 | Participants | ||
| The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Escalation Part 1: BMS 80 mg Q2W | 0 | Participants | ||
| The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Escalation Part 1: BMS 160 mg Q2W | 0 | Participants | ||
| The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Escalation Part 1: BMS 320 mg Q2W | 0 | Participants | ||
| The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 0 | Participants | ||
| The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 0 | Participants | ||
| The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 0 | Participants | ||
| The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 1 | Participants | ||
| The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 0 | Participants |
1 to 10 of 2,200Source ClinicalTrials.gov
See all 2,200 results by groupParticipant flow81
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Escalation Part 1: BMS 20 mg Q2W | 4 | |
| Overall Study | STARTED | Escalation Part 1: BMS 40 mg Q2W | 4 | |
| Overall Study | STARTED | Escalation Part 1: BMS 80 mg Q2W | 4 | |
| Overall Study | STARTED | Escalation Part 1: BMS 160 mg Q2W | 4 | |
| Overall Study | STARTED | Escalation Part 1: BMS 320 mg Q2W | 4 | |
| Overall Study | STARTED | Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 7 | |
| Overall Study | STARTED | Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 8 | |
| Overall Study | STARTED | Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 12 | |
| Overall Study | STARTED | Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 8 | |
| Overall Study | STARTED | Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 8 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 participant flowAdverse events10,287
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 | Escalation Part 1: BMS 20 mg Q2W | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Escalation Part 1: BMS 40 mg Q2W | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Escalation Part 1: BMS 80 mg Q2W | 2 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Escalation Part 1: BMS 160 mg Q2W | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Escalation Part 1: BMS 320 mg Q2W | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 3 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 4 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 2 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 1 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 1 | 8 |
1 to 10 of 10,287Source ClinicalTrials.gov
See all 10,287 adverse eventsAdverse event totals81
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Escalation Part 1: BMS 20 mg Q2W | 4 | 4 |
| Total, all-cause mortality | Escalation Part 1: BMS 40 mg Q2W | 4 | 4 |
| Total, all-cause mortality | Escalation Part 1: BMS 80 mg Q2W | 3 | 4 |
| Total, all-cause mortality | Escalation Part 1: BMS 160 mg Q2W | 4 | 4 |
| Total, all-cause mortality | Escalation Part 1: BMS 320 mg Q2W | 4 | 4 |
| Total, all-cause mortality | Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 3 | 7 |
| Total, all-cause mortality | Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 7 | 8 |
| Total, all-cause mortality | Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 11 | 12 |
| Total, all-cause mortality | Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 6 | 8 |
| Total, all-cause mortality | Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 6 | 8 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33148673 | DERIVED |
Source PubMed
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/NCT02737475
GET https://conductscience.org/api/trials/v1/NCT02737475/registered?page=2