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Completed

NCT Number: NCT04943900

A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid tumors.

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Key information

Conditions

Advanced Solid Tumors Adenocarcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Carcinoma, Transitional Cell Digestive System Diseases Digestive System Neoplasms Head and Neck Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms 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, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor
  • Eligible tumor types Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC), Squamous cell carcinoma of the head and neck (SCCHN), Hepatocellular carcinoma (HCC), Microsatellite-stable colorectal carcinoma (MSS CRC), or Pancreatic ductal adenocarcinoma (PDAC)
  • Resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit
  • Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
  • Disease amenable to serial biopsy

Exclusion criteria

  • Uncontrolled or significant cardiovascular disease
  • Known connective tissue disease such as Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome
  • Medical requirement for chronic anticoagulant or antiplatelet agents (except low-dose aspirin, which is permitted)

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986416

Drug

Specified dose on specified days

Nivolumab

Drug

Specified dose on specified days

Other names: BMS-936558, Opdivo

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 100 days after the last treatment of study intervention(s)

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 100 days after the last treatment of study intervention(s)

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

    Time frame: Up to 100 days after the last treatment of study intervention(s)

  4. Incidence of AEs leading to discontinuation

    Time frame: Up to 100 days after the last treatment of study intervention(s)

  5. Incidence of AEs leading to death

    Time frame: Up to 100 days after the last treatment of study intervention(s)

  6. Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD)

    Time frame: Up to 100 days after the last treatment of study intervention(s)

Secondary outcomes

  1. Maximum observed serum concentration (Cmax) of BMS-986416

    Time frame: Up to 100 days after the last treatment of study intervention(s)

  2. Time of maximum observed serum concentration (Tmax) of BMS-986416

    Time frame: Up to 100 days after the last treatment of study intervention(s)

  3. Trough observed serum concentration (Ctrough) of BMS-986416

    Time frame: Up to 100 days after the last treatment of study intervention(s)

  4. Overall Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per Investigator assessment

    Time frame: Up to 2 years

  5. Duration of Response (DOR) using RECIST 1.1 per Investigator assessment

    Time frame: Up to 2 years

  6. Incidence of clinically significant changes in ECG parameters: QTcF

    Time frame: Up to 100 days after the last treatment of study intervention(s)

    QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1 Study of BMS-986416 Alone and in Combination With Nivolumab in Select Solid Tumors

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 29, 2021
Registry last updated
Apr 9, 2025

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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