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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04943900
Recruitment Status : Recruiting
First Posted : June 29, 2021
Last Update Posted : May 26, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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 Intervention/treatment Phase
Advanced Solid Tumors Drug: BMS-986416 Drug: Nivolumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of BMS-986416 Alone and in Combination With Nivolumab in Select Solid Tumors
Actual Study Start Date : August 9, 2021
Estimated Primary Completion Date : November 13, 2023
Estimated Study Completion Date : November 14, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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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
Other Names:
  • BMS-936558
  • Opdivo


Outcome Measures
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04943900


Contacts
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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
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04943900    
Other Study ID Numbers: CA102-003
First Posted: June 29, 2021    Key Record Dates
Last Update Posted: May 26, 2023
Last Verified: May 2023

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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:
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Neoplasms
Nivolumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action