A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Begins enrollment in 1 month; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: BMS-986484; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06544655

EU 2024-513696-40 (Registry Identifier)

CA233-0000

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN).

Enrollment: 134 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Locally advanced unresectable, metastatic, or recurrent malignant tumors including non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), microsatellite stable colorectal cancer (MSS CRC), and squamous cell carcinoma of the head and neck (SCCHN).
• Must have measurable disease by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
• Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.

Exclusion criteria

• History of or with active interstitial lung disease or pulmonary fibrosis.
• Active, known, or suspected autoimmune disease.
• Serious uncontrolled medical disorders.
• New onset, non-catheter-associated venous thromboembolism within the past 6 months.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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134 participants in 4 patient groups

Part 1A: BMS-986484 Dose Escalation

Experimental group

Treatment:

Drug: BMS-986484

Part 1B: BMS-986484 + Nivolumab Dose Escalation

Experimental group

Treatment:

Biological: Nivolumab

Drug: BMS-986484

Part 2A: BMS-986484 Dose Expansion

Experimental group

Treatment:

Drug: BMS-986484

Part 2B: BMS-986484 + Nivolumab Dose Expansion

Experimental group

Treatment:

Biological: Nivolumab

Drug: BMS-986484