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

A Phase 1/1b First-in-human Trial of BMS-986484 as Monotherapy and Combination Therapy in Participants With Advanced Solid Malignancies

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Biological: Nivolumab; Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Capecitabine; Drug: BMS-986484; Drug: Calcium folinate

• Study Type: Interventional
• Enrollment (Estimated): 213
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Local Institution - 0021
  • South Australia
    • Elizabeth Vale, South Australia, Australia, 5112
      • Local Institution - 0019
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Local Institution - 0017
  • Quebec
    • Montreal, Quebec, Canada, H2X 0A9
      • Local Institution - 0016
• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Local Institution - 0003
  • California
    • Los Angeles, California, United States, 90033
      • Local Institution - 0007
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Local Institution - 0011
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Local Institution - 0004
  • Texas
    • San Antonio, Texas, United States, 78229
      • Local Institution - 0013

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1A: BMS-986484 Dose Escalation	Drug: BMS-986484; Specified dose on specified days
Experimental: Part 1B: BMS-986484 + Nivolumab Dose Escalation	Biological: Nivolumab; Specified dose on specified days; Other Names: Opdivo; Drug: BMS-986484; Specified dose on specified days
Experimental: Part 2A: BMS-986484 Dose Expansion	Drug: BMS-986484; Specified dose on specified days
Experimental: Part 2B: BMS-986484 + Nivolumab Dose Expansion	Biological: Nivolumab; Specified dose on specified days; Other Names: Opdivo; Drug: BMS-986484; Specified dose on specified days
Experimental: Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation	Biological: Nivolumab; Specified dose on specified days; Other Names: Opdivo; Drug: Fluorouracil; Specified dose on specified days; Drug: Oxaliplatin; Specified dose on specified days; Drug: Capecitabine; Specified dose on specified days; Drug: BMS-986484; Specified dose on specified days; Drug: Calcium folinate; Specified dose on specified days
Experimental: Part 1 Co-Admin: BMS-986484 + Nivolumab	Biological: Nivolumab; Specified dose on specified days; Other Names: Opdivo; Drug: BMS-986484; Specified dose on specified days
Experimental: Part 1SC: BMS-986484 Monotherapy Subcutaneous Dose Escalation	Drug: BMS-986484; Specified dose on specified days
Experimental: Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion	Biological: Nivolumab; Specified dose on specified days; Other Names: Opdivo; Drug: Fluorouracil; Specified dose on specified days; Drug: Oxaliplatin; Specified dose on specified days; Drug: Capecitabine; Specified dose on specified days; Drug: BMS-986484; Specified dose on specified days; Drug: Calcium folinate; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (AEs)	Up to approximately 2 years
Incidence of serious adverse events (SAEs)	Up to approximately 2 years
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria	Up to approximately 28 days
Incidence of AEs leading to discontinuation	Up to approximately 2 years
Incidence of AEs leading to death	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed concentration (Cmax)	Up to approximately 2 years
Time of maximum observed concentration (Tmax)	Up to approximately 2 years
Area under the concentration-time curve (AUC)	Up to approximately 2 years
Incidence of anti-drug antibodies (ADAs)	Up to approximately 2 years
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)	Up to approximately 2 years
Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)	Up to approximately 2 years
Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Estimated): October 14, 2027
• Study Completion (Estimated): October 14, 2027

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Immunotherapy; Chemotherapy; Non-small cell lung cancer (NSCLC); FOLFOX; CAPOX; Opdivo®; Pancreatic ductal adenocarcinoma (PDAC); anti-CD40; Squamous cell carcinoma of the head and neck (SCCHN); BMS-986484; Microsatellite stable (MSS) colorectal carcinoma (CRC); Gastric/gastroesophageal junction adenocarcinoma (G/GEJC); anti-FAP
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Genetic Diseases, Inborn; Intestinal Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Head and Neck Neoplasms; Neurodegenerative Diseases; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Lung Neoplasms; Carcinoma; Heredodegenerative Disorders, Nervous System; Carcinoma, Bronchogenic; Bronchial Neoplasms; Spinal Cord Diseases; Carcinoma, Squamous Cell; Cerebellar Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Squamous Cell Carcinoma of Head and Neck; Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Spinocerebellar Degenerations; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleic Acids, Nucleotides, and Nucleosides; Enzymes and Coenzymes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Uracil; Pyrimidinones; Coenzymes; Deoxyribonucleosides; Capecitabine; Oxaliplatin; Nivolumab; Fluorouracil; Leucovorin
• Other Study ID Numbers: CA233-0000; EU 2024-513696-40 (Registry Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No