Clinical trial · Interventional
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
NCT03184870CI-TRIAL-00096465completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil (5-FU) | Drug | Fluorouracil | ALIAS |
| BMS-813160 | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Nivolumab | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (13)
- type
- EXPERIMENTAL
- label
- Part 1 Arm A [First-line (1L) Colorectal]: BMS-813160 followed by BMS-813160 + FOLFIRI
- description
- FOLFIRI: FOL (folinic acid \[leucovorin\]) F (fluorouracil \[5-fluorouracil\]) IRI (irinotecan \[CAMPTOSAR\])
- interventionNames
- Drug: BMS-813160
- Drug: 5-fluorouracil (5-FU)
- Drug: Leucovorin
- Drug: Irinotecan
- type
- EXPERIMENTAL
- label
- Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxel
- interventionNames
- Drug: BMS-813160
- Drug: Nab-paclitaxel
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- Part 1 Arm C [2L Pancreatic & 2/3L Colorectal MSS]: BMS-813160 followed by BMS-813160 + Nivolumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLe 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. PMID 41571299