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

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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

Tracking Information
First Submitted Date  ICMJE April 15, 2020
First Posted Date  ICMJE April 16, 2020
Last Update Posted Date March 23, 2023
Actual Study Start Date  ICMJE July 14, 2020
Estimated Primary Completion Date April 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2020)
  • Incidence of adverse events (AEs) [ Time Frame: Up to 119 weeks ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Up to 119 weeks ]
  • Incidence of adverse events (AEs) meeting protocol-defined DLT (dose-limiting toxicity) criteria [ Time Frame: Up to 119 weeks ]
  • Incidence of adverse events (AEs) leading to discontinuation [ Time Frame: Up to 119 weeks ]
  • Number of deaths [ Time Frame: Up to 119 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2021)
  • Objective Response Rate (ORR) [ Time Frame: Up to 12 months ]
  • Duration of Response (DOR) [ Time Frame: Up to 12 months ]
  • Progression-Free Survival Rate (PFSR) [ Time Frame: Up to 12 months ]
  • Maximum observed serum concentration (Cmax) of BMS-986315 [ Time Frame: Up to 16 weeks ]
  • Maximum observed serum concentration (Cmax) of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ]
  • Maximum observed serum concentration (Cmax) of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ]
  • Time of maximum observed serum concentration (Tmax) of BMS-986315 [ Time Frame: Up to 16 weeks ]
  • Time of maximum observed serum concentration (Tmax) of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ]
  • Time of maximum observed serum concentration (Tmax) of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 [ Time Frame: Up to 16 weeks ]
  • Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ]
  • Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ]
  • Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 [ Time Frame: Up to 16 weeks ]
  • Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ]
  • Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ]
  • Trough observed serum concentrations (Ctrough) of BMS-986315 [ Time Frame: Up to 119 weeks ]
  • Incidence of anti-drug antibodies to BMS-986315 [ Time Frame: Up to 119 weeks ]
  • Incidence of anti-drug antibodies to BMS-986315 with nivolumab [ Time Frame: Up to 119 weeks ]
  • Incidence of anti-drug antibodies to BMS-986315 with cetuximab [ Time Frame: Up to 119 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2020)
  • Objective Response Rate (ORR) [ Time Frame: Up to 12 months ]
  • Duration of Response (DOR) [ Time Frame: Up to 12 months ]
  • Progression-Free Survival Rate (PFSR) [ Time Frame: Up to 12 months ]
  • Maximum observed serum concentration (Cmax) of BMS-986315 [ Time Frame: Up to 120 weeks ]
  • Maximum observed serum concentration (Cmax) of BMS-986315 with nivolumab [ Time Frame: Up to 120 weeks ]
  • Maximum observed serum concentration (Cmax) of BMS-986315 with cetuximab [ Time Frame: Up to 120 weeks ]
  • 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 120 weeks ]
  • 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 120 weeks ]
  • 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 120 weeks ]
  • Time of maximum observed serum concentration (Tmax) of BMS-986315 [ Time Frame: Up to 120 weeks ]
  • Time of maximum observed serum concentration (Tmax) of BMS-986315 with nivolumab [ Time Frame: Up to 120 weeks ]
  • Time of maximum observed serum concentration (Tmax) of BMS-986315 with cetuximab [ Time Frame: Up to 120 weeks ]
  • Incidence of anti-drug antibodies to BMS-986315 [ Time Frame: Up to 120 weeks ]
  • Incidence of anti-drug antibodies to BMS-986315 with nivolumab [ Time Frame: Up to 120 weeks ]
  • Incidence of anti-drug antibodies to BMS-986315 with cetuximab [ Time Frame: Up to 120 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
Official Title  ICMJE A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumor
Intervention  ICMJE
  • Biological: BMS-986315
    Specified dose on specified days
  • Biological: nivolumab
    Specified dose on specified days
  • Biological: cetuximab
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: BMS-986315
    Intervention: Biological: BMS-986315
  • Experimental: BMS-986315 + nivolumab
    Interventions:
    • Biological: BMS-986315
    • Biological: nivolumab
  • Experimental: BMS-986315 + cetuximab
    Interventions:
    • Biological: BMS-986315
    • Biological: cetuximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 15, 2020)		 308
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2025
Estimated Primary Completion Date April 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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 #.
Listed Location Countries  ICMJE Argentina,   Canada,   Chile,   Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04349267
Other Study ID Numbers  ICMJE CA047-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date March 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP