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

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT03184870

Acronym / sponsor ID

CV202-103

Conditions

Colorectal Cancer, Pancreatic Cancer

Phase

Phase 1/2

Study type

Interventional

Recruitment status

Completed

Enrolment

332 participants (actual)

Lead sponsor

Bristol-Myers SquibbIndustry (pharma, biotech, devices)

Study start

8 Aug 2017 (actual)

Primary completion

6 Apr 2023 (actual)

Study completion

14 Jun 2023 (actual)

First posted

14 Jun 2017 (actual)

Results

Posted 9 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

13

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants Experiencing Adverse Events (AEs)

   Time frame: 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.

2. Number of Participants Experiencing Serious Adverse Events (SAEs)

   Time frame: 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.

3. Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

   Time frame: 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.

4. Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation

   Time frame: 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.

5. Number of Participants Who Died

   Time frame: 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

6. Number of Participants Experiencing Laboratory Abnormalities

   Time frame: 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.

7. Vital Signs

   Time frame: 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.

8. Number of Participants With Out-of-Range Electrocardiograms (ECG)

   Time frame: 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.

9. Percent Change in Regulatory T Cells (Treg) in Tumor Samples

   Time frame: 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.

10. Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples

    Time frame: 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.

11. Objective Response Rate (ORR)

    Time frame: From first dose until disease progression, or the last response recorded (up to approximately 5 years)

    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.

12. Duration of Response (DoR)

    Time frame: From first dose up to date of disease progression or death, whichever occurs first (up to approximately 5 years)

    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.

13. Progression Free Survival (PFS) Rate at 24 Weeks

    Time frame: From first dose up to Week 24

    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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 41571299Le DT, Folprecht G, Varghese AM, Gutierrez M, Noel M, Trikalinos NA, Chen E, Dayyani F, Davis SL, Ma WW, BasuMallick A, Garrido-Laguna I, Osawa M, O'Brien S, Novosiadly RD, Xu K, Greenawalt DM, Dutta S, Twyman Saint Victor C, Lenz HJ. Phase 1b/2 study of BMS-813160, a CCR2/5 dual antagonist, in combination with chemotherapy or nivolumab in patients with advanced pancreatic or colorectal cancer. J Immunother Cancer. 2026 Jan 22;14(1):e011284. doi: 10.1136/jitc-2024-011284.
• BMS Clinical Trial InformationLink provided by the sponsor.
• BMS Clinical Trial Patient RecruitingLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

40 sites in 6 countries: see every site and its status.