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

• Status: Active, not recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Fluorouracil; Gemcitabine; Irinotecan; Leucovorin; Nivolumab; Paclitaxel

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