A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors

A Phase 1b/2 Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Pancreatic Cancer
• Intervention / Treatment: Biological: Nivolumab; Drug: Gemcitabine; Drug: Leucovorin; Drug: Irinotecan; Drug: BMS-813160; Drug: 5-fluorouracil (5-FU); Drug: Nab-paclitaxel

• Study Type: Interventional
• Enrollment (Actual): 332
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Clayton, Victoria, Australia
      • Local Institution - 0028
• Belgium
  • Brussels, Belgium, 1200
    • Local Institution - 0050
  • Edegem, Belgium, 2650
    • Local Institution - 0051
  • Leuven, Belgium, 3000
    • Local Institution - 0049
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Local Institution - 0013
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Local Institution - 0012
    • Toronto, Ontario, Canada, M5G 1X6
      • Local Institution - 0001
• Germany
  • Dresden, Germany, 01307
    • Local Institution - 0022
  • Heidelberg, Germany, 69120
    • Local Institution - 0007
• Spain
  • Barcelona, Spain, 08003
    • Local Institution - 0031
  • Madrid, Spain, 28046
    • Local Institution - 0032
  • Majadahonda - Madrid, Spain, 28222
    • Local Institution - 0030
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • Local Institution - 0003
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Local Institution - 0026
  • California
    • Los Angeles, California, United States, 90033
      • Local Institution - 0002
    • Los Angeles, California, United States, 90033
      • Local Institution - 0025
    • Orange, California, United States, 92868-3201
      • Local Institution - 0041
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Local Institution - 0015
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Local Institution - 0018
  • Florida
    • Brooksville, Florida, United States, 34613
      • Local Institution - 0048
    • St. Petersburg, Florida, United States, 33705
      • Local Institution - 0047
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Local Institution - 0005
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Local Institution - 0033
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Local Institution - 0027
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Local Institution - 0039
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Local Institution - 0023
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Local Institution - 0004
  • New York
    • New York, New York, United States, 10065
      • Local Institution - 0017
    • Rochester, New York, United States, 14642
      • Local Institution - 0024
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Local Institution - 0046
  • Ohio
    • Cleveland, Ohio, United States, 44106-5055
      • Local Institution - 0044
    • Cleveland, Ohio, United States, 44195
      • Local Institution - 0021
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Local Institution - 0037
    • Philadelphia, Pennsylvania, United States, 19104
      • Local Institution - 0014
    • Philadelphia, Pennsylvania, United States, 19107
      • Local Institution - 0020
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Local Institution - 0045
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Local Institution - 0034
    • Nashville, Tennessee, United States, 37232
      • Local Institution - 0038
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Local Institution - 0016
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Local Institution - 0042

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Must have metastatic colorectal or pancreatic cancer
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
• Ability to swallow pills or capsules
• Required to undergo mandatory pre and on-treatment biopsies
• Adequate marrow function
• Adequate other organ functions
• Ability to comply with study visits, treatment, procedures, pharmacokinetic (PK) and pharmacodynamic (PD) sample collection, and required study follow-up

Exclusion Criteria:

• Histology other than adenocarcinoma (neuroendocrine or acinar cell)
• Suspected, known, or central nervous system (CNS) metastases (Imaging required only if participants are symptomatic)
• Active, known or suspected autoimmune disease
• Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
• Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity
• Prior treatment with cysteine-cysteine chemokine receptor 2 (CCR2) and/or cysteine-cysteine chemokine receptor 5 (CCR5) inhibitors, programmed death-1 receptor (PD-1), programmed death-ligand 1 [PD(L)-1] or cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibodies
• History of allergy to study treatments or any of its components of the study arm that participant is enrolling

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

13

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 Arm A [First-line (1L) Colorectal]: BMS-813160 followed by BMS-813160 + FOLFIRI; FOLFIRI: FOL (folinic acid [leucovorin]) F (fluorouracil [5-fluorouracil]) IRI (irinotecan [CAMPTOSAR])	Drug: Leucovorin; Specified dose on specified days; Drug: Irinotecan; Specified dose on specified days; Drug: BMS-813160; Specified dose on specified days; Drug: 5-fluorouracil (5-FU); Specified dose on specified days
Experimental: Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxel	Drug: Gemcitabine; Specified dose on specified days; Drug: BMS-813160; Specified dose on specified days; Drug: Nab-paclitaxel; Specified dose on specified days
Experimental: Part 1 Arm C [2L Pancreatic & 2/3L Colorectal MSS]: BMS-813160 followed by BMS-813160 + Nivolumab; 2L: Second-line 2/3L: Second/third-line MSS: Microsatellite stable	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Drug: BMS-813160; Specified dose on specified days
Experimental: Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRI	Drug: Leucovorin; Specified dose on specified days; Drug: Irinotecan; Specified dose on specified days; Drug: BMS-813160; Specified dose on specified days; Drug: 5-fluorouracil (5-FU); Specified dose on specified days
Experimental: Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRI	Drug: Leucovorin; Specified dose on specified days; Drug: Irinotecan; Specified dose on specified days; Drug: BMS-813160; Specified dose on specified days; Drug: 5-fluorouracil (5-FU); Specified dose on specified days
Experimental: Part 2 Arm A Cohort 1c [2L Colorectal]: FOLFIRI	Drug: Leucovorin; Specified dose on specified days; Drug: Irinotecan; Specified dose on specified days; Drug: 5-fluorouracil (5-FU); Specified dose on specified days
Experimental: Part 2 Arm B Cohort 3a [1L Pancreatic]: BMS-813160 + Gemcitabine/Nab-paclitaxel	Drug: Gemcitabine; Specified dose on specified days; Drug: BMS-813160; Specified dose on specified days; Drug: Nab-paclitaxel; Specified dose on specified days
Experimental: Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxel	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Drug: Gemcitabine; Specified dose on specified days; Drug: BMS-813160; Specified dose on specified days; Drug: Nab-paclitaxel; Specified dose on specified days
Experimental: Part 2 Arm B Cohort 3c [1L Pancreatic]: Gemcitabine/Nab-paclitaxel	Drug: Gemcitabine; Specified dose on specified days; Drug: Nab-paclitaxel; Specified dose on specified days
Experimental: Part 2 Arm C Cohort 4 [2L Pancreatic]: BMS-813160 + Nivolumab	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Drug: BMS-813160; Specified dose on specified days
Experimental: Part 2 Arm C Cohort 5 [2/3L Colorectal MSS]: BMS-813160 + Nivolumab	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Drug: BMS-813160; Specified dose on specified days
Experimental: Part 2 Arm D Cohort 7 [2L Pancreatic]: BMS-813160 Monotherapy	Drug: BMS-813160; Specified dose on specified days
Experimental: Part 2 Arm D Cohort 8 [2/3L Colorectal MSS]: BMS-813160 Monotherapy	Drug: BMS-813160; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximim Concentration (Cmax)	Cmax is defined as the maximum plasma concentration of the analytes at the prespecified timepoints.	From first dose up to the prespecified timepoints, C0D1, C0D14, and C2D1
Time to Maximum Concentration (Tmax)	Tmax is defined as the time in hours of the maximum observed plasma concentration	From first dose up to the prespecified timpoints, C0D1, C0D14, AND C2D1
Trough Observed Plasma Concentration (Ctrough)	Ctrough is defined as the concentration reached by a drug immediately before the next dose is administered	From first dose up to prespecified timepoints, C0D1, C5D1, C0D1, C1D15, C5D1
Area Under Curve (AUC) 0-8	Area Under Curve (AUC) is defined as the area under the plot of plasma concentration of a drug versus time after dosage measured at 8 hours post-dose	From first dose up to prespecified timepoints- C0D1, C2D1
Area Under Curve (AUC) 0-24	Area Under Curve (AUC) is defined as the area under the plot of plasma concentration of a drug versus time after dosage measured at 8 hours post-dose	From first dose up to prespecified timepoints-C0D1, C2D1
Apparent Total Body Clearance (CLT/F)	The total body clearance (CLT/F) is defined as the volume of plasma completely cleared of drug per unit time	From first dose up to prespecified timepoints-C0D1, C2D14
Renal Clearance (CLR)	Renal clearance is defined as the rate at which the analytes were removed from the plasma by the kidneys.	From first dose up to prespecified timepoints-C0D1, C0D14
Number of Participants Who Were Anti-Drug Antibody (ADA) Positive	The number of participants who are anti-drug antibody positive. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment. ADA-positive sample is in a participant who is baseline ADA negative or with an ADA titer to be at least 4-fold or greater than baseline positive titer.	From first dose up to prespecified timepoints-C1D1, C1D15, C2D1, C3D1, C5D1, C9D1

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2017
• Primary Completion (Actual): April 6, 2023
• Study Completion (Actual): June 14, 2023

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: June 9, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Estimated): October 9, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Colonic Diseases; Colorectal Neoplasms; Pancreatic Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Camptothecin; Alkaloids; Enzymes and Coenzymes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Uracil; Pyrimidinones; Coenzymes; Nivolumab; Irinotecan; Gemcitabine; Fluorouracil; Leucovorin; 130-nm albumin-bound paclitaxel; BMS-813160
• Other Study ID Numbers: CV202-103; 2017-001725-40 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No