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Closed (no longer recruiting)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

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 patients with colorectal or pancreatic cancer.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

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.

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.

Ask your doctor if this trial could be right for you.

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