A Study of BMS-813160 in Combination with Chemotherapy or Nivolumab in Patients with Advanced Solid Tumors

Phase 1

• Conditions: Advanced Solid Tumors; MedDRA version: 20.0Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-001725-40-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-23
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 366

Inclusion Criteria

- Participants must have metastatic colorectal or pancreatic cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of =1
- Ability to swallow pills or capsules
- All participants will be required to undergo mandatory pre and on-treatment biopsies
- Adequate marrow function
- Adequate other organ functions
- Ability to comply with study visits, treatment, procedures, PK and PD sample collection, and required study follow-up
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 183
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 183

Exclusion Criteria

- Histology other than adenocarcinoma (neuroendocrine or acinar cell). If mixed tumor, the predominant histology must be adenocarcinoma;
- Suspected, known, or progressive CNS metastases (Imaging required only if participants are symptomatic); Participants with adequately treated CNS metastasis are eligible if the participant’s neurologic function returned to baseline and are not currently on steroids for
at least 2 weeks prior to study entry. Participants with history of brain metastasis require baseline MRI of the brain prior to study entry;
- Participants with active, known or suspected autoimmune disease
- Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration except for adrenal replacement steroid doses > 10 mg daily prednisone equivalent in the absence of active autoimmune disease (Treatment with a short course of steroids (< 5 days) up to 7 days prior to initiating study treatment is permitted)
- Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity
- Prior treatment with CCR2 and/or CCR5 inhibitors, PD-1, PD(L)-1 or CTLA-4 antibodies;
- History of allergy to study treatments or any of its components of the study arm that participant is enrolling

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified