An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread

Bristol-Myers Squibb (BMS)

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

Conditions: Advanced Cancer

Treatments: Biological: Nivolumab; Biological: BMS-986258; Drug: rHuPH20

Study type: Interventional

Funder types: Industry

Identifiers

NCT03446040

CA031-002

2019-000442-35 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic confirmation of one of the 5 tumors [renal cell carcinoma (RCC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC)] (metastatic, recurrent, and/or unresectable), with measurable disease per response evaluation criteria in solid tumors v1.1 (RECIST v1.1)
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Participants 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 solid tumor histologies
• Women must agree to follow specific methods of contraception, if applicable

Exclusion criteria

• Active, known or suspected autoimmune disease
• Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
• Other active malignancy requiring concurrent intervention

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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92 participants in 4 patient groups

Part A Dose Escalation: BMS-986258

Experimental group

Treatment:

Biological: BMS-986258

Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)

Experimental group

Treatment:

Drug: rHuPH20

Biological: BMS-986258

Part B Dose Escalation: BMS-986258 + nivolumab

Experimental group

Treatment:

Biological: Nivolumab

Biological: BMS-986258

Part C Cohort Expansion: BMS-986258 + nivolumab

Experimental group

Treatment:

Biological: Nivolumab

Biological: BMS-986258