An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Malignant Solid Tumor

Treatments: Biological: Nivolumab; Biological: BMS-986179; Biological: rHuPH20

Study type: Interventional

Funder types: Industry

Identifiers

NCT02754141

2016-000603-91 (EudraCT Number)

CA013-004

Details and patient eligibility

About

The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.

Enrollment: 235 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Inclusion Criteria:

• Solid cancers that are advanced or have spread (for which alternative therapies were deemed not effective)
• Eastern Cooperative Oncology Group (ECOG) 0-1
• Acceptable lab testing results
• Allow biopsies

Exclusion Criteria:

• Central nervous system (CNS) tumors
• Uncontrolled or significant cardiovascular diseases
• Active or known autoimmune disease
• Organ transplant

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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235 participants in 3 patient groups

Arm A-Monotherapy

Experimental group

Description:

BMS-986179, dose as specified

Treatment:

Biological: BMS-986179

Arm B- Combination Therapy

Experimental group

Description:

BMS-986179 + nivolumab, dose as specified

Treatment:

Biological: BMS-986179

Biological: Nivolumab

Arm C-Combination Therapy

Experimental group

Description:

BMS-986179 + rHuPH20, dose as specified

Treatment:

Biological: rHuPH20

Biological: BMS-986179