Brief Summary

The purpose of this study is to evaluate the safety profile, tolerability, drug levels, drug effects, and preliminary efficacy of BMS-813160 alone or in combination with either chemotherapy or nivolumab or chemotherapy plus nivolumab in participants with metastatic colorectal and pancreatic cancers.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

332

participants targeted

Target at P75+ for phase_1 colorectal-cancer

Timeline

Completed

Started Aug 2017

Longer than P75 for phase_1 colorectal-cancer

Geographic Reach

6 countries

40 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.9 years study duration

First Submitted

Initial submission to the registry

June 9, 2017

Completed

5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed

2 months until next milestone

Study Start

First participant enrolled

August 8, 2017

Completed

5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2023

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2023

Completed

2.3 years until next milestone

Results Posted

Study results publicly available

October 9, 2025

Completed

Last Updated

October 9, 2025

Status Verified

September 1, 2025

Enrollment Period

5.7 years

First QC Date

June 9, 2017

Results QC Date

June 14, 2024

Last Update Submit

September 22, 2025

Conditions

Colorectal Cancer Pancreatic Cancer

Outcome Measures

Primary Outcomes (13)

Number of Participants Experiencing Adverse Events (AEs)
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.
From first dose up to 100 days post last dose, up to approximately 3 years
Number of Participants Experiencing Serious Adverse Events (SAEs)
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.
From first dose up to 100 days post last dose, up to approximately 3 years
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
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.
From first dose up to 100 days post last dose, up to approximately 3 years
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
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.
From first dose up to 100 days post last dose, up to approximately 3 years
Number of Participants Who Died
The number of participants who died within 100 days after receiving their last dose
From first dose up to 100 days post last dose, up to approximately 3 years
Number of Participants Experiencing Laboratory Abnormalities
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.
From first dose up to 100 days post last dose, up to approximately 3 years
Vital Signs
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.
From first dose to 100 days post last dose, up to approximately 3 years
Number of Participants With Out-of-Range Electrocardiograms (ECG)
The number of participants with ECG measurements outside of the range pre-specified in the protocol.
From baseline up to 100 days post last dose
Percent Change in Regulatory T Cells (Treg) in Tumor Samples
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.
From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1)
Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples
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.
From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1)
Objective Response Rate (ORR)
Objective Response Rate (ORR) as determined by Investigator was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. Progression is defined as at least 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. 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.
From first dose until disease progression, or the last response recorded (up to approximately 5 years)
Duration of Response (DoR)
Duration of Response (DOR), computed for all treated participants with a best overall response (BOR) of complete response (CR) or partial response (PR), is defined as the time between the date of first response (CR or PR) and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause, whichever occurs first, ie., DOR = disease progression date/death date -first response date + 1. For participants who remain alive and have not progressed, DOR will be censored on the date of their last tumor assessment. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose up to date of disease progression or death, whichever occurs first (up to approximately 5 years)
Progression Free Survival (PFS) Rate at 24 Weeks
PFS rate is defined as the proportion of participants who were progression free at Week 24. PFS is defined as the time from first dose to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Progression is defined at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Complete response (CR)= Disappearance of all target lesions. Pathological lymph nodes must have short axis reduction to \< 10 mm. Partial response (PR)= At least 30% decrease in sum of diameters of target lesions. Participants who died w/o prior progression were considered progressed on death date. Those alive and not progressed were censored on the last tumor assessment date. Those who started subsequent therapy without reported progression were censored at last tumor assessment prior to subsequent therapy. Those without post-baseline tumor assessment and alive were censored at first dose.
From first dose up to Week 24

Secondary Outcomes (8)

Maximim Concentration (Cmax)
From first dose up to the prespecified timepoints, C0D1, C0D14, and C2D1
Time to Maximum Concentration (Tmax)
From first dose up to the prespecified timpoints, C0D1, C0D14, AND C2D1
Trough Observed Plasma Concentration (Ctrough)
From first dose up to prespecified timepoints, C0D1, C5D1, C0D1, C1D15, C5D1
Area Under Curve (AUC) 0-8
From first dose up to prespecified timepoints- C0D1, C2D1
Area Under Curve (AUC) 0-24
From first dose up to prespecified timepoints-C0D1, C2D1
+3 more secondary outcomes

Study Arms (13)

Part 1 Arm A [First-line (1L) Colorectal]: BMS-813160 followed by BMS-813160 + FOLFIRI

EXPERIMENTAL

FOLFIRI: FOL (folinic acid \[leucovorin\]) F (fluorouracil \[5-fluorouracil\]) IRI (irinotecan \[CAMPTOSAR\])

Drug: BMS-813160Drug: 5-fluorouracil (5-FU)Drug: LeucovorinDrug: Irinotecan

Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxel

EXPERIMENTAL

Drug: BMS-813160Drug: Nab-paclitaxelDrug: Gemcitabine

Part 1 Arm C [2L Pancreatic & 2/3L Colorectal MSS]: BMS-813160 followed by BMS-813160 + Nivolumab

EXPERIMENTAL

2L: Second-line 2/3L: Second/third-line MSS: Microsatellite stable

Drug: BMS-813160Biological: Nivolumab

Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRI

EXPERIMENTAL

Drug: BMS-813160Drug: 5-fluorouracil (5-FU)Drug: LeucovorinDrug: Irinotecan

Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRI

EXPERIMENTAL

Drug: BMS-813160Drug: 5-fluorouracil (5-FU)Drug: LeucovorinDrug: Irinotecan

Part 2 Arm A Cohort 1c [2L Colorectal]: FOLFIRI

EXPERIMENTAL

Drug: 5-fluorouracil (5-FU)Drug: LeucovorinDrug: Irinotecan

Part 2 Arm B Cohort 3a [1L Pancreatic]: BMS-813160 + Gemcitabine/Nab-paclitaxel

EXPERIMENTAL

Drug: BMS-813160Drug: Nab-paclitaxelDrug: Gemcitabine

Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxel

EXPERIMENTAL

Drug: BMS-813160Biological: NivolumabDrug: Nab-paclitaxelDrug: Gemcitabine

Part 2 Arm B Cohort 3c [1L Pancreatic]: Gemcitabine/Nab-paclitaxel

EXPERIMENTAL

Drug: Nab-paclitaxelDrug: Gemcitabine

Part 2 Arm C Cohort 4 [2L Pancreatic]: BMS-813160 + Nivolumab

EXPERIMENTAL

Drug: BMS-813160Biological: Nivolumab

Part 2 Arm C Cohort 5 [2/3L Colorectal MSS]: BMS-813160 + Nivolumab

EXPERIMENTAL

Drug: BMS-813160Biological: Nivolumab

Part 2 Arm D Cohort 7 [2L Pancreatic]: BMS-813160 Monotherapy

EXPERIMENTAL

Drug: BMS-813160

Part 2 Arm D Cohort 8 [2/3L Colorectal MSS]: BMS-813160 Monotherapy

EXPERIMENTAL

Drug: BMS-813160