Trial · NCT03184870
A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors
NCT03184870, Phase 1, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2025-10-09
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors. Trials, record NCT03184870. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03184870
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors
- NCT number
- NCT03184870
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 332 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Colorectal Cancer, Pancreatic Cancer
- Interventions
- BMS-813160, Nivolumab, Nab-paclitaxel, Gemcitabine, 5-fluorouracil (5-FU), Leucovorin, Irinotecan
- First posted
- 2017-06-14
- Last updated
- 2025-10-09
- Other registries' IDs
- eudract:2017-001725-40
- Results first posted
- 2025-10-09
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing Adverse Events (AEs) | From first dose up to 100 days post last dose, up to approximately 3 years | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. |
| Primary | Number of Participants Experiencing Serious Adverse Events (SAEs) | From first dose up to 100 days post last dose, up to approximately 3 years | A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization. |
| Primary | Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | From first dose up to 100 days post last dose, up to approximately 3 years | Dose-limiting toxicities (DLTs) are severe adverse effects (AEs) that are attributed to BMS-813160 or the combination regimen and define the maximum tolerated dose of a medicine. DLTs will be defined based on the incidence, duration and grade of AEs for which no alternate cause can be identified. AEs will be evaluated according to the NCI CTCAE v4.03. The incidence of DLT(s) during the first 6 weeks of treatment in Part 1 (the DLT evaluation period) and 4 weeks for Part 2 will be used. |
| Primary | Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | From first dose up to 100 days post last dose, up to approximately 3 years | An Adverse Event (AE) leading to discontinuation is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment that leads to the discontinuation of study treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. |
| Primary | Number of Participants Who Died | From first dose up to 100 days post last dose, up to approximately 3 years | The number of participants who died within 100 days after receiving their last dose |
| Primary | Number of Participants Experiencing Laboratory Abnormalities | From first dose up to 100 days post last dose, up to approximately 3 years | The number of participants experiencing laboratory abnormalities in pre-specified selected parameters during the treatment period per CTCAE (Version 4). Laboratory abnormalities are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. |
| Primary | Vital Signs | From first dose to 100 days post last dose, up to approximately 3 years | Vital sign measurements at baseline and at the end of treatment. Baseline evaluations will be defined as evaluations with a date on or prior to the day of first dose of study treatment. |
| Primary | Number of Participants With Out-of-Range Electrocardiograms (ECG) | From baseline up to 100 days post last dose | The number of participants with ECG measurements outside of the range pre-specified in the protocol. |
| Primary | Percent Change in Regulatory T Cells (Treg) in Tumor Samples | From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1) | The percent change in Regulatory T Cells (Treg) were taken at prespecified timepoints. Baseline is defined as the last non-missing value prior to the first dosing. |
| Primary | Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples | From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1) | The percent change in Tumor-Associated Macrophages (TAMs) were taken at prespecified timepoints. Baseline is defined as the last non-missing value prior to the first dosing. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
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 (AEs) | From first dose up to 100 days post last dose, up to approximately 3 years | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Experiencing Serious Adverse Events (SAEs) | From first dose up to 100 days post last dose, up to approximately 3 years | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | From first dose up to 100 days post last dose, up to approximately 3 years | All treated participants who completed the DLT evaluation period | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | From first dose up to 100 days post last dose, up to approximately 3 years | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Died | From first dose up to 100 days post last dose, up to approximately 3 years | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Experiencing Laboratory Abnormalities | From first dose up to 100 days post last dose, up to approximately 3 years | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Vital Signs | From first dose to 100 days post last dose, up to approximately 3 years | All treated participants with vital sign measurements | mmHg | MEAN |
| PRIMARY | Number of Participants With Out-of-Range Electrocardiograms (ECG) | From baseline up to 100 days post last dose | All treated participants with out-of-range ECGs | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percent Change in Regulatory T Cells (Treg) in Tumor Samples | From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1) | All treated participants with immunohistochemistry data | Percent change in Treg | MEDIAN |
| PRIMARY | Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples | From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1) | All treated participants with immunohistochemistry data | Percent change in TAM | MEDIAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group762
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 (AEs) | Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI | 10 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) | Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI | 8 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) | Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB | 10 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) | Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB | 11 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) | Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO | 8 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) | Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO | 7 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) | Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO | 7 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) | Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO | 11 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) | Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO | 1 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) | Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO | 2 | Participants |
1 to 10 of 762Source ClinicalTrials.gov
See all 762 results by groupParticipant flow108
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Treatment | STARTED | Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI | 10 | |
| Initial Treatment | STARTED | Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI | 8 | |
| Initial Treatment | STARTED | Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB | 10 | |
| Initial Treatment | STARTED | Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB | 11 | |
| Initial Treatment | STARTED | Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO | 8 | |
| Initial Treatment | STARTED | Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO | 7 | |
| Initial Treatment | STARTED | Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO | 7 | |
| Initial Treatment | STARTED | Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO | 11 | |
| Initial Treatment | STARTED | Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO | 1 | |
| Initial Treatment | STARTED | Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO | 2 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 participant flowAdverse events7,074
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-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIR | 4 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI | 4 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB | 5 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB | 5 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO | 4 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO | 3 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO | 2 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO | 1 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO | 0 | 2 |
1 to 10 of 7,074Source ClinicalTrials.gov
See all 7,074 adverse eventsAdverse event totals54
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIR | 6 | 10 |
| Total, all-cause mortality | Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI | 6 | 8 |
| Total, all-cause mortality | Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB | 8 | 10 |
| Total, all-cause mortality | Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB | 8 | 11 |
| Total, all-cause mortality | Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO | 6 | 8 |
| Total, all-cause mortality | Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO | 6 | 7 |
| Total, all-cause mortality | Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO | 6 | 7 |
| Total, all-cause mortality | Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO | 7 | 11 |
| Total, all-cause mortality | Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO | 1 | 1 |
| Total, all-cause mortality | Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO | 2 | 2 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41571299 | 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/NCT03184870
GET https://conductscience.org/api/trials/v1/NCT03184870/registered?page=2