Safety, Tolerability, Pharmacokinetic/Pharmacodynamic and Preliminary Efficacy Study of BMS-986205 Administered in Combination With Nivolumab in Advanced Cancers

Phase 1

• Conditions: Advanced Malignant Tumors; MedDRA version: 19.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004914-79-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: 2016-08-05
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

•Patients must have been diagnosed with cancer and had at least 1 prior standard treatment
•Must be able to swallow pills or capsules
•Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1
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 173
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 115

Exclusion Criteria

•Any prior ongoing clinical study with Nivolumab with overall survival as an endpoint
•Requirement for daily supplemental oxygen
•Myocardial infarction or stroke/transient ischemic attack within the past 6 months
•Uncontrolled angina within the past 3 months
•History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus(HIV), or acquired immune deficiency syndrome(AIDS)

Study & Design

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