An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: BMS-986299; Biological: Ipilimumab; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03444753

CA039-001

Details and patient eligibility

About

The purpose of this study is to determine whether BMS-986299 both by itself and in combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced solid tumors. In addition, the ability of study drugs to stimulate an immune response against cancer will be investigated.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed advanced/metastatic solid tumor and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
• IO therapy resistant or insensitive tumors
• Have at least 2 tumor lesions accessible for biopsy
• Eastern Cooperative Oncology Group Performance Status of 0 or 1

Exclusion criteria

• Primary CNS malignancy
• Participants with other active malignancy requiring concurrent intervention
• Uncontrolled or significant cardiovascular disease

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Arm A

Experimental group

Description:

BMS-986299

Treatment:

Drug: BMS-986299

Arm B

Experimental group

Description:

BMS-986299 in combination with nivolumab and ipilimumab

Treatment:

Biological: Nivolumab

Biological: Ipilimumab

Drug: BMS-986299