A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Advanced Cancer

Treatments: Biological: BMS-986249; Biological: Nivolumab; Biological: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03369223

CA030-001

2018-000416-21 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

Enrollment: 425 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cancer and have at least 1 lesion accessible for biopsy. For Part 2B participants with HCC, intermediate disease is allowed.
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to tumor type, if such a therapy exists
• Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants
• Willing and able to comply with all study procedures

Exclusion criteria

• Primary central nervous system (CNS) malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded
• Other active malignancy requiring concurrent intervention
• Prior organ allograft
• Active, known, or suspected autoimmune disease

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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425 participants in 11 patient groups

Part 1A: BMS-986249

Experimental group

Treatment:

Biological: BMS-986249

Part 1B: BMS-986249 + nivolumab (nivo)

Experimental group

Treatment:

Biological: Nivolumab

Biological: BMS-986249

Part 2A Arm C: BMS-986249 + nivo

Experimental group

Description:

Previously untreated unresectable stage III-IV melanoma

Treatment:

Biological: Nivolumab

Biological: BMS-986249

Part 2A Arm D: ipilimumab + nivo then nivo

Experimental group

Description:

Previously untreated unresectable stage III-IV melanoma

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Part 2A Arm F: BMS-986249 + nivo

Experimental group

Description:

Previously untreated unresectable stage III-IV melanoma

Treatment:

Biological: Nivolumab

Biological: BMS-986249

Part 2B Cohort 1: BMS-986249 + nivo

Experimental group

Description:

Advanced or intermediate hepatocellular carcinoma (HCC)

Treatment:

Biological: Nivolumab

Biological: BMS-986249

Part 2B Cohort 2: BMS-986249 + nivo

Experimental group

Description:

Metastatic castration-resistant prostate cancer (CRPC)

Treatment:

Biological: Nivolumab

Biological: BMS-986249

Part 2B Cohort 3: BMS-986249 + nivo

Experimental group

Description:

Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)

Treatment:

Biological: Nivolumab

Biological: BMS-986249

Part 2A Arm A: BMS-986249 + nivo then nivo

Experimental group

Description:

Previously untreated unresectable stage III-IV melanoma Enrollment is closed for this Arm

Treatment:

Biological: Nivolumab

Biological: BMS-986249

Part 2A Arm B: BMS-986249 + nivo

Experimental group

Description:

Previously untreated unresectable stage III-IV melanoma Enrollment is closed for this Arm

Treatment:

Biological: Nivolumab

Biological: BMS-986249

Part 2A Arm E: Nivo

Experimental group

Description:

Previously untreated unresectable stage III-IV melanoma Enrollment is closed for this Arm

Treatment:

Biological: Nivolumab