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An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Terminated
CT.gov ID
NCT03444753
Collaborator
(none)
82
Enrollment
9
Locations
2
Arms
46.4
Actual Duration (Months)
9.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether BMS-986299 both by itself and in combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced solid tumors. In addition, the ability of study drugs to stimulate an immune response against cancer will be investigated.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Study of BMS-986299 as Monotherapy and in Combination With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
Actual Study Start Date :
Apr 5, 2018
Actual Primary Completion Date :
Feb 14, 2022
Actual Study Completion Date :
Feb 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

BMS-986299

Drug: BMS-986299
Specified dose on specified day
Experimental: Arm B

BMS-986299 in combination with nivolumab and ipilimumab

Drug: BMS-986299
Specified dose on specified day

Biological: Nivolumab
Specified dose on specified day
Other Names:
  • Opdivo
  • BMS-936558

    • Biological: Ipilimumab
    Specified dose on specified day
    Other Names:
  • Yervoy
  • BMS-734016

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of dose-limiting toxicities (DLTs) [Up to 28 days]

    2. Incidence of adverse events (AEs) [Approximately 2 years]

    3. Incidence of clinical laboratory abnormalities [Approximately 2 years]

    4. Incidence of serious adverse events (SAEs) [Approximately 2 years]

    5. Incidence of AEs leading to discontinuation and deaths [Approximately 2 years]

    Secondary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) [Approximately 2 years]

    2. Time of maximum observed plasma concentration (Tmax) [Approximately 2 years]

    3. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [Approximately 2 years]

    4. Area under the plasma concentration-time curve from time zero to 24 hours postdose [AUC(0-24)] [Approximately 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically or cytologically confirmed advanced/metastatic solid tumor and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant

    • IO therapy resistant or insensitive tumors

    • Have at least 2 tumor lesions accessible for biopsy

    • Eastern Cooperative Oncology Group Performance Status of 0 or 1

    Exclusion Criteria:

    • Primary CNS malignancy

    • Participants with other active malignancy requiring concurrent intervention

    • Uncontrolled or significant cardiovascular disease

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution - 0003 La Jolla California United States 92093-0698
    2 Local Institution Orange California United States 92868
    3 University of California Davis Medical Center Sacramento California United States 95817
    4 Local Institution New Haven Connecticut United States 06520
    5 Local Institution Detroit Michigan United States 48202
    6 Washington University Saint Louis Missouri United States 63110
    7 Local Institution Portland Oregon United States 97239
    8 Local Institution Pittsburgh Pennsylvania United States 15232-1305
    9 MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03444753
    Other Study ID Numbers:
    • CA039-001
    First Posted:
    Feb 23, 2018
    Last Update Posted:
    May 23, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Nivolumab
    Ipilimumab

    Study Results

    No Results Posted as of May 23, 2022