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Trial record 1 of 1 for:    CA099-003
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A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05407675
Recruitment Status : Active, not recruiting
First Posted : June 7, 2022
Last Update Posted : March 15, 2024
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE June 2, 2022
First Posted Date  ICMJE June 7, 2022
Last Update Posted Date March 15, 2024
Actual Study Start Date  ICMJE August 2, 2022
Estimated Primary Completion Date October 14, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2022)
  • Number of participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]
  • Number of participants with Adverse Events (AEs) [ Time Frame: Up to 29 months ]
  • Number of deaths [ Time Frame: Up to 50 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2022)
  • Maximum concentration (Cmax) [ Time Frame: Up to 27 months ]
  • Time of maximum observed concentration (Tmax) [ Time Frame: Up to 27 months ]
  • Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC (0-T)) [ Time Frame: Up to 27 months ]
  • Objective Response Rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 50 months ]
  • Duration of Response (DOR) assessed by RECIST v1.1 [ Time Frame: Up to 50 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors
Official Title  ICMJE A Phase 1/2 Study of BMS-986408 Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors
Brief Summary The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE
  • Drug: BMS-986408
    Specified dose on specified days
  • Biological: Nivolumab
    Specified dose on specified days
    Other Names:
    • Opdivo
    • BMS-936558
  • Biological: Ipilimumab
    Specified dose on specified days
    Other Names:
    • Yervoy
    • BMS-734016
  • Biological: Platinum-doublet chemotherapy
    Specified dose on specified days
    Other Names:
    • PDCT
    • carbplatin, paclitaxel, pemetrexed, cisplatin
  • Drug: Rabeprazole
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: Part 1: BMS-986408 Monotherapy
    Intervention: Drug: BMS-986408
  • Experimental: Part 2: BMS-986408 in combination with nivolumab
    Interventions:
    • Drug: BMS-986408
    • Biological: Nivolumab
  • Experimental: Part 2: BMS-986408 in combination with nivolumab and ipilimumab
    Interventions:
    • Drug: BMS-986408
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Part 2: BMS-986408 in combination with nivolumab and chemotherapy
    Interventions:
    • Drug: BMS-986408
    • Biological: Nivolumab
    • Biological: Platinum-doublet chemotherapy
  • Experimental: Part 2: BMS-986408 in combination with rabeprazole
    Interventions:
    • Drug: BMS-986408
    • Drug: Rabeprazole
  • Experimental: Part 3: BMS-986408 in combination with nivolumab
    Interventions:
    • Drug: BMS-986408
    • Biological: Nivolumab
  • Experimental: Part 3: BMS-986408 in combination with nivolumab and chemotherapy
    Interventions:
    • Drug: BMS-986408
    • Biological: Nivolumab
    • Biological: Platinum-doublet chemotherapy
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 12, 2024)		 402
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2022)		 122
Estimated Study Completion Date  ICMJE October 14, 2025
Estimated Primary Completion Date October 14, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants with a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy of any histology measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Participants who have received, been refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
  • Participants with melanoma should have documentation of mutation status for B-type Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS)
  • Participants must have experienced radiographically documented progressive disease on or after the most recent therapy

Exclusion Criteria:

  • An active, known or suspected autoimmune disease
  • Conditions requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
  • Current or recent gastrointestinal disease or gastrointestinal surgery that could impact the absorption of study drug
  • Untreated central nervous system (CNS) metastases or leptomeningeal metastasis

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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Spain,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05407675
Other Study ID Numbers  ICMJE CA099-003
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 2024

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