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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced Cancer; Melanoma; Non-Small Cell Lung Cancer

Treatments: Drug: BMS-986205; Drug: Nivolumab; Drug: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02658890

CA017-003

2015-004914-79 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 627 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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627 participants in 3 patient groups

Combination Therapy (Dose Escalation)

Experimental group

Description:

BMS 986205 + Nivolumab specified dose at specified intervals.

Treatment:

Drug: Nivolumab

Drug: BMS-986205

Combination Therapy (Dose Expansion)

Experimental group

Description:

BMS 986205 + Nivolumab specified dose at specified intervals.

Treatment:

Drug: Nivolumab

Drug: BMS-986205

Combination Therapy 2 (Dose Expansion)

Experimental group

Description:

BMS 986205 + both Nivolumab and ipilimumab specified dose at specified intervals

Treatment:

Drug: Ipilimumab

Drug: Nivolumab

Drug: BMS-986205