A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03400332
Collaborator
(none)
372
71
5
75.8
5.2
0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
372 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
Actual Study Start Date :
Feb 12, 2018
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Jun 8, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1A: BMS-986253 + nivolumab

Drug: BMS-986253
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
  • Experimental: Part 1B: BMS-986253 + nivolumab

    Drug: BMS-986253
    Specified dose on specified days

    Biological: Nivolumab
    Specified dose on specified days
    Other Names:
  • BMS-936558
  • Opdivo
  • Experimental: Part 1C: BMS-986253 + nivolumab + ipilimumab

    Drug: BMS-986253
    Specified dose on specified days

    Biological: Nivolumab
    Specified dose on specified days
    Other Names:
  • BMS-936558
  • Opdivo
  • Biological: Ipilimumab
    Specified dose on specified days
    Other Names:
  • BMS-734016
  • YERVOY
  • Experimental: Part 2A: BMS-986253 + nivolumab + ipilimumab

    Drug: BMS-986253
    Specified dose on specified days

    Biological: Nivolumab
    Specified dose on specified days
    Other Names:
  • BMS-936558
  • Opdivo
  • Biological: Ipilimumab
    Specified dose on specified days
    Other Names:
  • BMS-734016
  • YERVOY
  • Placebo Comparator: Part 2B: Placebo + nivolumab + ipilimumab

    Biological: Nivolumab
    Specified dose on specified days
    Other Names:
  • BMS-936558
  • Opdivo
  • Biological: Ipilimumab
    Specified dose on specified days
    Other Names:
  • BMS-734016
  • YERVOY
  • Other: Placebo
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events (AE) [Approximately 5 years]

      Part 1

    2. Incidence of serious adverse events (SAE) [Approximately 5 years]

      Part 1

    3. Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria [Approximately 5 years]

      Part 1

    4. Incidence of AEs leading to discontinuation [Approximately 5 years]

      Part 1

    5. Incidence of deaths [Approximately 5 years]

      Part 1

    6. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Approximately 5 years]

      Part 1

    7. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [Approximately 5 years]

      Part 1

    8. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Approximately 5 years]

      Part 1

    9. Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Approximately 5 years]

      Part 2, participants with advanced melanoma, selected by baseline serum interleukin-8 (IL-8) level using RECIST v1.1

    Secondary Outcome Measures

    1. Objective response rate (ORR) based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Approximately 5 years]

      Part 1 and Part 2

    2. Median duration of response (mDOR) per response evaluation criteria in solid tumors (RECIST) v1.1 [Approximately 5 years]

      Part 1

    3. Incidence of anti-drug antibody (ADA) to BMS-986253 [Approximately 5 years]

      Part 1 and Part 2

    4. Serum biomarker concentration [Approximately 5 years]

      Part 1

    5. Maximum observed serum concentration (Cmax) [Approximately 5 years]

      Part 1 and Part 2

    6. Time of maximum observed serum concentration (Tmax) [Approximately 5 years]

      Part 1 and Part 2

    7. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [Approximately 5 years]

      Part 1 and Part 2

    8. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [Approximately 5 years]

      Part 1 and Part 2

    9. Observed serum concentration at the end of a dosing interval (CTAU) [Approximately 5 years]

      Part 1 and Part 2

    10. Trough observed serum concentration at the end of the dosing interval (CTROUGH) [Approximately 5 years]

      Part 1 and Part 2

    11. Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Approximately 5 years]

      Part 2, participants with advanced melanoma, using RECIST v1.1 (regardless of baseline serum IL-8 levels)

    12. Overall Survival (OS) [Approximately 5 years]

      Part 2

    13. Incidence of AEs [Approximately 5 years]

      Part 2

    14. Incidence of SAEs [Approximately 5 years]

      Part 2

    15. Incidence of AEs leading to discontinuation [Approximately 5 years]

      Part 2

    16. Incidence of death [Approximately 5 years]

      Part 2

    17. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Approximately 5 years]

      Part 2

    18. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [Approximately 5 years]

      Part 2

    19. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Approximately 5 years]

      Part 2

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1

    • At least 1 lesion accessible for biopsy

    • Eastern Cooperative Oncology Group Performance Status of 0 or 1

    Exclusion Criteria:
    • Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)

    • Participants with active, known or suspected autoimmune disease

    • Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration

    • Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)

    • Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy

    Other protocol defined inclusion/exclusion criteria could apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Springdale Arkansas United States 72762
    2 Local Institution Aurora Colorado United States 80045
    3 Rocky Mountain Cancer Centers Denver Colorado United States 80218
    4 Local Institution Miami Beach Florida United States 33140
    5 Local Institution Atlanta Georgia United States 30322
    6 Maryland Oncology Hematology P.A. Columbia Maryland United States 21044
    7 Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins Lutherville Maryland United States 21093
    8 University Of Michigan Health System Ann Arbor Michigan United States 48109
    9 Local Institution Omaha Nebraska United States 68130
    10 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89169
    11 John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey United States 07601
    12 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08901
    13 Icahn School Of Medicine At Mount Sinai New York New York United States 10029
    14 Columbia University Medical Center (Cumc) New York New York United States 10032
    15 Stephenson Cancer Center Oklahoma City Oklahoma United States 73104
    16 Willamette Valley Cancer Institute And Research Center Eugene Oregon United States 97401
    17 Local Institution Philadelphia Pennsylvania United States 19111
    18 UPMC Cancer Center Pittsburgh Pennsylvania United States 15213
    19 Greenville Health System Greenville South Carolina United States 29605
    20 Texas Oncology-Austin Midtown Austin Texas United States 78705
    21 Texas Oncology - Baylor Charles A. Simmons Cancer Center Dallas Texas United States 75246
    22 Local Institution Fort Worth Texas United States 76104-3927
    23 MD Anderson Cancer Center Houston Texas United States 77030
    24 Texas Oncology-San Antonio Medical Center San Antonio Texas United States 78240
    25 Texas Oncology - DFWW Tyler Texas United States 75702
    26 Local Institution Salt Lake City Utah United States 84112
    27 Virginia Cancer Specialists, PC Fairfax Virginia United States 22031
    28 Virginia Oncology Associates Norfolk Virginia United States 23502
    29 Local Institution Richmond Virginia United States 23298
    30 Local Institution Wollstonecraft New South Wales Australia 2065
    31 Local Institution Adelaide South Australia Australia 5000
    32 Local Institution Ballarat Central Victoria Australia 3350
    33 Local Institution Epping Victoria Australia 3076
    34 Local Institution - 0095 Melbourne Victoria Australia 3004
    35 Local Institution Nedlands Western Australia Australia 6009
    36 Local Institution Bruxelles Belgium 1200
    37 Local Institution - 0036 Gent Belgium 9000
    38 Local Institution Edmonton Alberta Canada T6G 1Z2
    39 Local Institution - 0029 Vancouver British Columbia Canada V5Z 4E6
    40 Local Institution Victoria British Columbia Canada V8R 6V5
    41 Local Institution Toronto Ontario Canada M5G 1Z5
    42 Local Institution Toronto Ontario Canada M5G 2M9
    43 Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies Montréal Canada H2X 3E4
    44 Local Institution - 0067 Marseille France 13385
    45 Local Institution - 0085 Nantes France 44000
    46 Local Institution - 0068 Paris France 75010
    47 Local Institution Villejuif France 94800
    48 Local Institution Berlin Germany 12203
    49 Local Institution Gerlingen Germany 70839
    50 Local Institution Hamburg Germany 20246
    51 Local Institution Hamburg Germany 20251
    52 Local Institution Mainz Germany 55131
    53 Local Institution Mainz Germany 55131
    54 Local Institution Tuebingen Germany 72076
    55 IRST Meldola Forlì Italy 47014
    56 Local Institution - 0042 Milano Italy 20132
    57 Istituto Nazionale Tumori Fondazione Pascale Napoli Italy 80131
    58 Local Institution Rozzano-milano Italy 20089
    59 Local Institution Krakow Poland 31-115
    60 Local Institution Warszawa Poland 02-781
    61 Local Institution - 0045 Madrid Spain 28034
    62 Local Institution - 0022 Madrid Spain 28040
    63 Local Institution - 0023 Madrid Spain 28050
    64 Hospital Universitario Virgen De La Victoria Malaga Spain 29010
    65 Local Institution - 0021 Pamplona Spain 31008
    66 Hospital Clinico Univ. de Santiago-CHUS Santiago Compostela Spain 15706
    67 Chu Vaudois Lausanne Lausanne Switzerland 1011
    68 Kantonsspital St. Gallen St.Gallen Switzerland 9007
    69 University Hospital Zuerich Zuerich Switzerland 8091
    70 Local Institution - 0024 Manchester Greater Manchester United Kingdom M20 4BX
    71 Local Institution Birmingham West Midlands United Kingdom B15 2TH

    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:
    NCT03400332
    Other Study ID Numbers:
    • CA027-002
    • 2018-000340-26
    First Posted:
    Jan 17, 2018
    Last Update Posted:
    May 18, 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:

    Study Results

    No Results Posted as of May 18, 2022