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

Bristol-Myers Squibb (BMS) logo

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)

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

Trial contacts and locations

11

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Central trial contact

BMS Study Connect Contact Center www.BMSStudyConnect.com; First line of the email MUST contain NCT # and Site #.

Data sourced from clinicaltrials.gov

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