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Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced 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: NCT04349267
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : March 23, 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 BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Biological: BMS-986315 Biological: nivolumab Biological: cetuximab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
Actual Study Start Date : July 14, 2020
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : May 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BMS-986315 Biological: BMS-986315
Specified dose on specified days
Experimental: BMS-986315 + nivolumab Biological: BMS-986315
Specified dose on specified days

Biological: nivolumab
Specified dose on specified days
Experimental: BMS-986315 + cetuximab Biological: BMS-986315
Specified dose on specified days

Biological: cetuximab
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Up to 119 weeks ]
  2. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 119 weeks ]
  3. Incidence of adverse events (AEs) meeting protocol-defined DLT (dose-limiting toxicity) criteria [ Time Frame: Up to 119 weeks ]
  4. Incidence of adverse events (AEs) leading to discontinuation [ Time Frame: Up to 119 weeks ]
  5. Number of deaths [ Time Frame: Up to 119 weeks ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 12 months ]
  2. Duration of Response (DOR) [ Time Frame: Up to 12 months ]
  3. Progression-Free Survival Rate (PFSR) [ Time Frame: Up to 12 months ]
  4. Maximum observed serum concentration (Cmax) of BMS-986315 [ Time Frame: Up to 16 weeks ]
  5. Maximum observed serum concentration (Cmax) of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ]
  6. Maximum observed serum concentration (Cmax) of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ]
  7. Time of maximum observed serum concentration (Tmax) of BMS-986315 [ Time Frame: Up to 16 weeks ]
  8. Time of maximum observed serum concentration (Tmax) of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ]
  9. Time of maximum observed serum concentration (Tmax) of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ]
  10. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 [ Time Frame: Up to 16 weeks ]
  11. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ]
  12. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ]
  13. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 [ Time Frame: Up to 16 weeks ]
  14. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ]
  15. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ]
  16. Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 [ Time Frame: Up to 16 weeks ]
  17. Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ]
  18. Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ]
  19. Trough observed serum concentrations (Ctrough) of BMS-986315 [ Time Frame: Up to 119 weeks ]
  20. Incidence of anti-drug antibodies to BMS-986315 [ Time Frame: Up to 119 weeks ]
  21. Incidence of anti-drug antibodies to BMS-986315 with nivolumab [ Time Frame: Up to 119 weeks ]
  22. Incidence of anti-drug antibodies to BMS-986315 with cetuximab [ Time Frame: Up to 119 weeks ]

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 must have histologic confirmation of advanced (metastatic, recurrent, and/or unresectable) squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1
  • Participants expected to have received standard of care therapies including an available PD-(L)1 inhibitor
  • Eastern cooperative oncology group performance status of 0 or 1
  • Women of childbearing potential must agree to follow methods of contraception

Exclusion Criteria:

  • Participants with active, known or suspected autoimmune disease
  • Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
  • Uncontrolled or significant cardiovascular disease
  • History of or with active interstitial lung disease or pulmonary fibrosis
  • Prior participation in anti-natural killer cell receptor (anti-NKG2A) clinical study
  • History of allergy or hypersensitivity to study drug components

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): NCT04349267


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 the email MUST contain NCT # and Site #.

Locations
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United States, Arizona
Banner MD Anderson Cancer Center Withdrawn
Gilbert, Arizona, United States, 85234
United States, Maryland
Local Institution Withdrawn
Baltimore, Maryland, United States, 21287
United States, North Carolina
Wake Forest Baptist Health Withdrawn
Winston-Salem, North Carolina, United States, 27157
United States, South Dakota
Sanford Clinic Clinical Research Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Steven Powell, Site 0028    605-328-8000      
United States, Tennessee
The West Clinic, P.C. Recruiting
Germantown, Tennessee, United States, 38138
Contact: Daniel Vaena, Site 0001    901-598-1454      
Argentina
Local Institution Withdrawn
Capital Federal, Distrito Federal, Argentina, C1428
Canada, British Columbia
Local Institution - 0011 Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Site 0011         
Local Institution Withdrawn
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Local Institution Withdrawn
Ottawa, Ontario, Canada, K1H 8L6
Local Institution - 0004 Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 0004         
Canada, Quebec
Local Institution - 0005 Recruiting
Montreal, Quebec, Canada, H2X 3E4
Contact: Site 0005         
Canada
Local Institution - 0014 Recruiting
Edmonton, Canada, T6X 1E8
Contact: Site 0014         
Local Institution - 0013 Recruiting
Ottawa, Canada, K1H 8L6
Contact: Site 0013         
Chile
Local Institution Withdrawn
Recoleta, Metropolitana, Chile
Mexico
Local Institution Not yet recruiting
Mexico city, Distrito Federal, Mexico, 06100
Contact: Site 0023         
Local Institution Not yet recruiting
Monterrey, Nuevo LEON, Mexico, 64460
Contact: Site 0018         
Local Institution Not yet recruiting
San Luis Potosi, Mexico, 78250
Contact: Site 0017         
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: NCT04349267    
Other Study ID Numbers: CA047-004
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: March 23, 2023
Last Verified: March 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:
NSCLC (Non-small cell lung cancer)
RCC (Renal cell carcinoma)
SCCHN (Squamous cell carcinoma of the head and neck)
Additional relevant MeSH terms:
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Neoplasms
Nivolumab
Cetuximab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action