An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread

• Status: Active, not recruiting
• Trial end date: 2021-10-25
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Ipilimumab; Linrodostat; Nivolumab

Criteria

For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• During dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen

• During cohort expansion, subjects with advanced cancer 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 a tumor biopsy during screening.

• 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

Exclusion Criteria:

• Active or chronic autoimmune diseases

• Uncontrolled or significant cardiovascular disease

• History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS)

• Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)

• Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease

• Active infection

Other protocol defined inclusion/exclusion criteria could apply