Clinical trial

A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

Name

CA027-002

Description

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.

Trial arms

Trial start

2018-02-12

Estimated PCD

2024-04-30

Trial end

2025-11-30

Status

Active (not recruiting)

Phase

Early phase I

Treatment

BMS-986253

Specified dose on specified days

Arms:

Part 1A: BMS-986253 + nivolumab, Part 1B: BMS-986253 + nivolumab, Part 1C: BMS-986253 + nivolumab + ipilimumab, Part 2A: BMS-986253 + nivolumab + ipilimumab

Nivolumab

Specified dose on specified days

Arms:

Part 1A: BMS-986253 + nivolumab, Part 1B: BMS-986253 + nivolumab, Part 1C: BMS-986253 + nivolumab + ipilimumab, Part 2A: BMS-986253 + nivolumab + ipilimumab, Part 2B: Placebo + nivolumab + ipilimumab

Other names:

BMS-936558, Opdivo

Ipilimumab

Specified dose on specified days

Arms:

Part 1C: BMS-986253 + nivolumab + ipilimumab, Part 2A: BMS-986253 + nivolumab + ipilimumab, Part 2B: Placebo + nivolumab + ipilimumab

Other names:

BMS-734016, YERVOY

Placebo

Specified dose on specified days

Arms:

Part 2B: Placebo + nivolumab + ipilimumab

Size

372

Primary endpoint

Incidence of adverse events (AE)

Approximately 5 years

Incidence of serious adverse events (SAE)

Approximately 5 years

Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria

Approximately 5 years

Incidence of AEs leading to discontinuation

Approximately 5 years

Incidence of deaths

Approximately 5 years

Incidence of clinically significant changes in clinical laboratory results: Hematology tests

Approximately 5 years

Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

Approximately 5 years

Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

Approximately 5 years

Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Approximately 5 years

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 372, 'type': 'ESTIMATED'}}

Updated at

2024-02-13

1 organization

3 products

2 indications

Product

Indication

Indication

Product

Product

Organization