A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

Bristol-Myers Squibb (BMS)

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

Conditions: Melanoma; Cancer

Treatments: Biological: Ipilimumab; Other: Placebo; Drug: BMS-986253; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03400332

2023-509061-20 (Registry Identifier)

CA027-002

Details and patient eligibility

About

The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.

Enrollment: 281 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 per RECIST v1.1
• At least 1 lesion accessible for biopsy
• Eastern Cooperative Oncology Group Performance Status of 0 or 1

Exclusion criteria

• Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
• Participants with active, known or suspected autoimmune disease
• Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
• Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
• Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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281 participants in 5 patient groups, including a placebo group

Part 1A: BMS-986253 + nivolumab

Experimental group

Treatment:

Biological: Nivolumab

Drug: BMS-986253

Part 1B: BMS-986253 + nivolumab

Experimental group

Treatment:

Biological: Nivolumab

Drug: BMS-986253

Part 1C: BMS-986253 + nivolumab + ipilimumab

Experimental group

Treatment:

Biological: Nivolumab

Drug: BMS-986253

Biological: Ipilimumab

Part 2A: BMS-986253 + nivolumab + ipilimumab

Experimental group

Treatment:

Biological: Nivolumab

Drug: BMS-986253

Biological: Ipilimumab

Part 2B: Placebo + nivolumab + ipilimumab

Placebo Comparator group

Treatment:

Biological: Nivolumab

Other: Placebo

Biological: Ipilimumab