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No longer recruiting (closed or complete)Last updated: 30 January 2024

This phase I/II trial is evaluating the safety and effectiveness of an oral drug (BMS-813160) alone or in combination with immunotherapy (Nivolumab) and/or chemotherapy in patients with advanced solid cancers, particularly colorectal cancer or pancreatic cancerA Phase 1b/2 Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Clinical summary

Summary

This is a non-randomised trial, in which patients will be assigned to one of seven experimental arms, receiving BMS-813160 alone or as a combination therapy. Combination therapies will include one or more of the following: Nivolumab, Nab-paclitaxel, Gemcitabine, 5-fluoroucil (5-fu), leucovorin and/or Irinotecan.

Conditions

This trial is treating people with colorectal or pancreatic cancer

Eligibility

Inclusion

  • 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

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

Exclusion

  • 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

Inclusion

  • You are able to swallow medication by mouth.
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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No longer recruiting (closed or complete) hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

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

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