A Phase 1/2a Study of BMS-986205 Administered in Combination with Nivolumab (anti-PD-1 Monoclonal Antibody) and in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Cancers

Phase 1

• Conditions: Advanced Malignant Tumors; MedDRA version: 20.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004914-79-PL
• 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: 2017-06-07
• Last Update Posted: 8 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 907

Inclusion Criteria

• During dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen
• During cohort expansion, subjects with various solid tumors that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type
• Subjects must have measurable disease
• Subject must consent to provide previously collected tumor tissue and must consent to a repeat tumor biopsy during screening.
• Women and men =18 years of age with performance status of 0 or 1
• At least 4 weeks since any previous treatment for cancer
• 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 544
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 363

Exclusion Criteria

• Active or chronic autoimmune diseases
• Uncontrolled or significant cardiovascular disease
• Chronic hepatitis
Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)Other protocol defined inclusion/exclusion criteria could apply
• Uncontrolled or significant cardiovascular disease
• Active infection
• History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus(HIV), or acquired immune deficiency syndrome(AIDS)
• Active Central nervous system (CNS) metastases and CNS metastases as the only sites of disease

Study & Design

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