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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors

  • Clinicaltrials.gov identifier

    NCT04349267

  • Recruitment Status

    Recruiting

  • First Posted

    April 16, 2020

  • Last update posted

    September 30, 2021

Study Description

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:Advanced Solid Tumor
  • Intervention/Treatment: Biological: BMS-986315
    Biological: nivolumab
    Biological: cetuximab
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • 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 2020
  • Estimated Primary Completion Date: July 2023
  • Estimated Study Completion Date: October 2024

Arms and interventions

Arm Intervention/treatment
Experimental: BMS-986315
Biological: BMS-986315
Specified dose on specified days
Experimental: BMS-986315 + cetuximab
Biological: BMS-986315
Specified dose on specified days

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

Biological: nivolumab
Specified dose on specified days

Outcome Measures

  • 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. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 [ Time Frame: Up to 16 weeks ]
  • 2. 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 ]
  • 3. Objective Response Rate (ORR) [ Time Frame: Up to 12 months ]
  • 4. Duration of Response (DOR) [ Time Frame: Up to 12 months ]
  • 5. Progression-Free Survival Rate (PFSR) [ Time Frame: Up to 12 months ]
  • 6. Maximum observed serum concentration (Cmax) of BMS-986315 [ Time Frame: Up to 16 weeks ]
  • 7. Maximum observed serum concentration (Cmax) of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ]
  • 8. Maximum observed serum concentration (Cmax) of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ]
  • 9. Time of maximum observed serum concentration (Tmax) of BMS-986315 [ Time Frame: Up to 16 weeks ]
  • 10. Time of maximum observed serum concentration (Tmax) of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ]
  • 11. Time of maximum observed serum concentration (Tmax) of BMS-986315 with cetuximab [ 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 [ Time Frame: Up to 16 weeks ]
  • 13. 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 ]
  • 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

  • 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

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

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

Locations

United States, Maryland
Local Institution
Baltimore

United States, South Dakota
Sanford Clinic Clinical Research
Sioux Falls

United States, Tennessee
The West Clinic, P.C.
Germantown

Argentina, Buenos Aires
Local Institution
Capital Federal

Canada, Alberta
Local Institution
Edmonton

Canada, British Columbia
Local Institution
Vancouver

Canada, British Columbia
Local Institution
Vancouver

Canada, Ontario
Local Institution
Ottawa

Canada, Ontario
Local Institution
Ottawa

Canada, Ontario
Local Institution
Toronto

Canada, Quebec
Local Institution
Montreal

Chile, Metropolitana
Local Institution
Recoleta

Mexico, Distrito Federal
Local Institution
Mexico city

Mexico, Nuevo LEON
Local Institution
Monterrey

Mexico
Local Institution
San Luis Potosi

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: NCT04349267 History of Changes
  • Other Study ID Numbers: CA047-004
  • First Posted: April 16, 2020 Key Record Dates
  • Last Update Posted: September 30, 2021
  • Last Verified: September 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: SCCHN (Squamous cell carcinoma of the head and neck)
    RCC (Renal cell carcinoma)
    NSCLC (Non-small cell lung cancer)
  • Additional relevant MeSH terms: Neoplasms