An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: BMS-986288; Drug: Regorafenib; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03994601

2021-004284-27 (EudraCT Number)

CA043-001

Details and patient eligibility

About

The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.

Enrollment: 219 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies

Exclusion criteria

• Active, known or suspected autoimmune disease
• Active malignancy requiring concurrent intervention
• Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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219 participants in 3 patient groups

Arm A: BMS-986288 Monotherapy

Experimental group

Treatment:

Drug: BMS-986288

Arm B: BMS-986288 in combination with Nivolumab

Experimental group

Treatment:

Drug: Nivolumab

Drug: BMS-986288

Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib

Experimental group

Treatment:

Drug: Nivolumab

Drug: Regorafenib

Drug: BMS-986288