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

  • Clinicaltrials.gov identifier

    NCT04943900

  • Recruitment Status

    Recruiting

  • First Posted

    June 29, 2021

  • Last update posted

    March 8, 2022

Study Description

Brief summary:

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.

  • Condition or Disease:Advanced Solid Tumors
  • Intervention/Treatment: Drug: BMS-986416
    Drug: Nivolumab
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 134 participants
  • Allocation: Non-Randomized
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors
  • Actual Study Start Date: August 2021
  • Estimated Primary Completion Date: November 2023
  • Estimated Study Completion Date: November 2023

Arms and interventions

Arm Intervention/treatment
Experimental: Part 1A: Monotherapy (BMS-986416)
Drug: BMS-986416
Specified dose on specified days
Experimental: Part 1B: Combination Therapy (BMS-986416 + Nivolumab)
Drug: BMS-986416
Specified dose on specified days

Drug: Nivolumab
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 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 Outcome Measures: 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

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of email MUST contain NCT # and Site #.

Locations

United States, Georgia
Local Institution
Atlanta

United States, Maryland
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics
Baltimore

United States, New Jersey
John Theurer Cancer Center
Hackensack

United States, Ohio
Local Institution
Cleveland

United States, Pennsylvania
UPMC Hillman Cancer Center
Pittsburgh

United States, Texas
University of Texas MD Anderson Cancer Center-Investigational Cancer Therapeutics
Houston

Canada, Alberta
Local Institution
Edmonton

Canada, Ontario
Local Institution
Toronto

Canada, Quebec
Local Institution
Montréal

Japan, Tokyo
Local Institution
Chuo-ku

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04943900 History of Changes
  • Other Study ID Numbers: CA102-003
  • First Posted: June 29, 2021 Key Record Dates
  • Last Update Posted: March 8, 2022
  • Last Verified: March 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: BMS-986416
    Nivolumab
    Opdivo
    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)
    Pancreatic ductal adenocarcinoma (PDAC)
  • Additional relevant MeSH terms: Neoplasms