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An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02754141
Collaborator
(none)
234
Enrollment
24
Locations
3
Arms
63.7
Actual Duration (Months)
9.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.

Condition or Disease Intervention/Treatment Phase
  • Biological: BMS-986179
  • Biological: Nivolumab
  • Biological: rHuPH20
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
234 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors
Actual Study Start Date :
Jun 21, 2016
Actual Primary Completion Date :
Oct 12, 2021
Actual Study Completion Date :
Oct 12, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A-Monotherapy

BMS-986179, dose as specified

Biological: BMS-986179
Specified dose on specified days
Experimental: Arm B- Combination Therapy

BMS-986179 + nivolumab, dose as specified

Biological: BMS-986179
Specified dose on specified days

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

    		•
    Experimental: Arm C-Combination Therapy

    BMS-986179 + rHuPH20, dose as specified

    Biological: BMS-986179
    Specified dose on specified days

    Biological: rHuPH20
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Number of adverse events (AE), serious adverse events (SAE), AEs leading to discontinuation, and deaths [Up to 100 days after the last dose of study drug]

    Secondary Outcome Measures

    1. The effect of BMS-986179 on CD73 enzymatic activity in pre- and on-treatment biopsies [Approximately 63 days]

    2. The effect of BMS-986179 on CD73 protein expression in pre- and on-treatment biopsies [Approximately 63 days]

    3. Objective response rate (ORR) [Approximately 2 years]

    4. Duration of response (DOR) [Approximately 2 years]

    5. Progression free survival rate (PFSR) [Approximately 2 years]

    6. Maximum observed serum concentration (Cmax) [Up to 100 days after the last dose of study drug]

    7. Time of maximum observed serum concentration (Tmax) [Up to 100 days after the last dose of study drug]

    8. Area under the serum concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)] [Up to 100 days after the last dose of study drug]

    9. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [Up to 100 days after the last dose of study drug]

    10. Apparent terminal half-life (T-HALF) [Up to 100 days after the last dose of study drug]

    11. Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] [Up to 100 days after the last dose of study drug]

    12. Effective elimination half-life (T-HALFeff) [Up to 100 days after the last dose of study drug]

    13. Concentration at the end of the dosing interval (Ctau) [Up to 100 days after the last dose of study drug]

    14. Trough observed serum concentration at the end of the dosing interval (Ctrough) [Up to 100 days after the last dose of study drug]

    15. Total body clearance (CLT) [Up to 100 days after the last dose of study drug]

    16. Volume of distribution at steady state (Vss) [Up to 100 days after the last dose of study drug]

    17. Accumulation index (AI) [Up to 100 days after the last dose of study drug]

    18. Apparent volume of distribution of terminal phase (Vz) [Up to 100 days after the last dose of study drug]

    19. Degree of fluctuation or fluctuation index (DF) [Up to 100 days after the last dose of study drug]

    20. Frequency of positive anti-drug antibody (ADA) to BMS-986179 [Up to 100 days after the last dose of study drug]

    21. Frequency of positive anti-drug antibody (ADA) to nivolumab [Up to 100 days after the last dose of study drug]

    Eligibility Criteria

    Criteria

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

    For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

    Inclusion Criteria:

    • Solid cancers that are advanced or have spread (for which alternative therapies were deemed not effective)

    • Eastern Cooperative Oncology Group (ECOG) 0-1

    • Acceptable lab testing results

    • Allow biopsies

    Exclusion Criteria:

    • Central nervous system (CNS) tumors

    • Uncontrolled or significant cardiovascular diseases

    • Active or known autoimmune disease

    • Organ transplant

    Other protocol defined inclusion/exclusion criteria could apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern University Feinberg School of Medicine Chicago Illinois United States 60611
    2 Johns Hopkins University Baltimore Maryland United States 21287
    3 Local Institution - 0022 Boston Massachusetts United States 02215
    4 Roswell Park Cancer Institute Buffalo New York United States 14263
    5 Columbia University Medical Center (Cumc) New York New York United States 10032
    6 Local Institution Pittsburgh Pennsylvania United States 15232
    7 Tennessee Oncology, PLLC - SCRI - PPDS Nashville Tennessee United States 37203
    8 Mary Crowley Medical Research Center Dallas Texas United States 75230
    9 St Vincent'S Hospital (Nsw) Darlinghurst Australian Capital Territory Australia 2010
    10 Scientia Clinical Research Limited Randwick New South Wales Australia 2031
    11 Local Institution - 0018 Melbourne Victoria Australia 3004
    12 Local Institution - 0003 Ottawa Ontario Canada K1H 8L6
    13 Princess Margaret Cancer Centre Toronto Ontario Canada M5G 1Z5
    14 Local Institution Montreal Quebec Canada H2X 3E4
    15 Sir Mortimer B Davis Jewish General Hospital Montreal Quebec Canada H3T 1E2
    16 Hopital De La Timone Marseille Cedex 5 France 13385
    17 Local Institution Marseille France 13273
    18 Institut Claudius Regaud Toulouse Cedex 9 France 31059
    19 Institut Gustave Roussy Villejuif Cedex France 94805
    20 Klinikum Der Albrecht-Ludwigs-Universitat Freiburg Germany 79106
    21 Klinikum rechts der Isar der Technischen Universitat Muenchen Klinik und Poliklinik fur Innere Mediz Munich Germany 81675
    22 Instituto Nazionale Tumori Fondazione G. Pascale Napoli Italy 80131
    23 I.O.V. Istituto Oncologico Veneto Ircss Padova Italy Padova
    24 Local Institution Amsterdam Netherlands 1066 CX

    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:
    NCT02754141
    Other Study ID Numbers:
    • CA013-004
    • 2016-000603-91
    First Posted:
    Apr 28, 2016
    Last Update Posted:
    May 27, 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

    Study Results

    No Results Posted as of May 27, 2022