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Active, Not Recruiting

NCT Number: NCT06544655

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Advanced Solid Tumors Brain Diseases Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Central Nervous System Diseases Cerebellar Diseases Colonic Diseases Colorectal Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Head and Neck Neoplasms Heredodegenerative Disorders, Nervous System Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Neurodegenerative Diseases Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Spinal Cord Diseases Spinocerebellar Degenerations Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0021, Darlinghurst, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986484

Drug

Specified dose on specified days

Nivolumab

Biological

Specified dose on specified days

Other names: Opdivo

Oxaliplatin

Drug

Specified dose on specified days

Capecitabine

Drug

Specified dose on specified days

Fluorouracil

Drug

Specified dose on specified days

Calcium folinate

Drug

Specified dose on specified days

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to approximately 2 years

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to approximately 2 years

  3. Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria

    Time frame: Up to approximately 28 days

  4. Incidence of AEs leading to discontinuation

    Time frame: Up to approximately 2 years

  5. Incidence of AEs leading to death

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to approximately 2 years

  2. Time of maximum observed concentration (Tmax)

    Time frame: Up to approximately 2 years

  3. Area under the concentration-time curve (AUC)

    Time frame: Up to approximately 2 years

  4. Incidence of anti-drug antibodies (ADAs)

    Time frame: Up to approximately 2 years

  5. Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    Time frame: Up to approximately 2 years

  6. Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    Time frame: Up to approximately 2 years

  7. Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    Time frame: Up to approximately 2 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 9, 2024
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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