Phase 2
Completed N=315
A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors
Source: ClinicalTrials.gov NCT03184870 ↗Enrolled (actual)
315
Serious AEs
54.0%
Results posted
Oct 2025
Primary outcomePrimary: Number of Participants Experiencing Adverse Events (AEs) — 10; 8; 10; 11 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Adverse Events (AEs) |
10; 8; 10; 11; 8; 7 | — |
| PRIMARY Number of Participants Experiencing Serious Adverse Events (SAEs) |
5; 5; 5; 7; 5; 6 | — |
| PRIMARY Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) |
0; 0; 2; 2; 0; 0 | — |
| PRIMARY Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation |
2; 0; 1; 6; 0; 1 | — |
| PRIMARY Number of Participants Who Died |
6; 6; 8; 8; 6; 6 | — |
| PRIMARY Number of Participants Experiencing Laboratory Abnormalities |
2; 4; 5; 7; 2; 1 | — |
| PRIMARY Vital Signs |
133.0; 129.7; 130.2; 143.0; 114.0; 125.0 | — |
| PRIMARY Number of Participants With Out-of-Range Electrocardiograms (ECG) |
7; 8; 10; 8; 8; 7 | — |
| PRIMARY Percent Change in Regulatory T Cells (Treg) in Tumor Samples |
26.6; -43.8; -22.9; 156.4; 57.3; -18.4 | — |
| PRIMARY Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples |
13.1; -12.7; 95.4; 133.6; 477.5; 22.1 | — |
| PRIMARY Objective Response Rate (ORR) |
60.0; 25.0; 0; 18.2; 0; 0 | — |
| PRIMARY Duration of Response (DoR) |
159.00; NA; NA; 74.14; 56.57; 36.21 | — |
| PRIMARY Progression Free Survival (PFS) Rate at 24 Weeks |
0.778; NA; 0.556; 0.800; NA; 0.357 | — |
| SECONDARY Maximim Concentration (Cmax) |
620.4; 2204.1; 828.4; 2419.0; 486.3; 1896.3 | — |
| SECONDARY Time to Maximum Concentration (Tmax) |
2.000; 0.500; 3.017; 2.492; 2.492; 2.983 | — |
| SECONDARY Trough Observed Plasma Concentration (Ctrough) |
283.70; 84.30; 292.0; 74.05; 157.28; 137.0 | — |
| SECONDARY Area Under Curve (AUC) 0-8 |
2300.018; 7069.265; 2725.390; 7884.381; 1534.932; 6593.904 | — |
| SECONDARY Area Under Curve (AUC) 0-24 |
9383.385; 11726.669; 10447.179; 4829.881; 1275.314; 7687.658 | — |
| SECONDARY Apparent Total Body Clearance (CLT/F) |
1163.173; 744.746; 1521.863; 826.468; 1602.009; 961.379 | — |
| SECONDARY Renal Clearance (CLR) |
212.411; 275.309; 139.012; 165.327; 155.820; 181.930 | — |
| SECONDARY Number of Participants Who Were Anti-Drug Antibody (ADA) Positive |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03184870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.