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Trial record 1 of 1 for:    NCT02754141
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An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab

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ClinicalTrials.gov Identifier: NCT02754141
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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
Malignant Solid Tumor Biological: BMS-986179 Biological: Nivolumab Drug: rHuPH20 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 221 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 : June 20, 2016
Estimated Primary Completion Date : July 12, 2020
Estimated Study Completion Date : September 19, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

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

Drug: rHuPH20
Specified dose on specified days




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

Secondary Outcome Measures :
  1. BMS-986179 enzyme assays in pre- and on-treatment biopsies [ Time Frame: Approximately 63 days ]
  2. BMS-986179 immunohistochemistry (IHC) in pre- and on-treatment biopsies [ Time Frame: Approximately 63 days ]
  3. Objective response rate (ORR) [ Time Frame: Approximately 2 years ]
  4. Duration of response (DOR) [ Time Frame: Approximately 2 years ]
  5. Progression free survival rate (PFSR) [ Time Frame: Approximately 2 years ]
  6. Maximum observed serum concentration (Cmax) [ Time Frame: Up to 100 days after the last dose of study drug ]
  7. Time of maximum observed serum concentration (Tmax) [ Time Frame: 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)] [ Time Frame: 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)] [ Time Frame: Up to 100 days after the last dose of study drug ]
  10. Apparent terminal half-life (T-HALF) [ Time Frame: 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)] [ Time Frame: Up to 100 days after the last dose of study drug ]
  12. Effective elimination half-life (T-HALFeff) [ Time Frame: Up to 100 days after the last dose of study drug ]
  13. Concentration at the end of the dosing interval (Ctau) [ Time Frame: Up to 100 days after the last dose of study drug ]
  14. Trough observed serum concentration at the end of the dosing interval (Ctrough) [ Time Frame: Up to 100 days after the last dose of study drug ]
  15. Total body clearance (CLT) [ Time Frame: Up to 100 days after the last dose of study drug ]
  16. Volume of distribution at steady state (Vss) [ Time Frame: Up to 100 days after the last dose of study drug ]
  17. Accumulation index (AI) [ Time Frame: Up to 100 days after the last dose of study drug ]
  18. Apparent volume of distribution of terminal phase (Vz) [ Time Frame: Up to 100 days after the last dose of study drug ]
  19. Degree of fluctuation or fluctuation index (DF) [ Time Frame: Up to 100 days after the last dose of study drug ]
  20. Frequency of positive anti-drug antibody (ADA) to BMS-986179 [ Time Frame: Up to 100 days after the last dose of study drug ]
  21. Frequency of positive anti-drug antibody (ADA) to nivolumab [ Time Frame: Up to 100 days after the last dose of study drug ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Inclusion Criteria:

  • Men and women at least 18 years of age
  • Advanced solid tumors
  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754141


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Dung Le, Site 0001    443-287-0002      
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: F. Stephen Hodi, Site 0022    617-632-5695      
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Marc Ernstoff, Site 0023    716-845-1164      
Columbia University Medical Center (Cumc) Recruiting
New York, New York, United States, 10032
Contact: Richard Carvajal, Site 0005         
United States, Pennsylvania
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232-1305
Contact: James Lee, Site 0020    412-648-6586      
United States, Tennessee
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
Contact: Howard Burris, Site 0004    615-329-7274      
United States, Texas
Mary Crowley Medical Research Center Recruiting
Dallas, Texas, United States, 75230
Contact: James Strauss, Site 0009    214-658-1985      
Australia, New South Wales
The Kinghorn Cancer Centre Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Anthony Joshua, Site 0017    +61293555783      
Scientia Clinical Research Limited Recruiting
Randwick, New South Wales, Australia, 2031
Contact: James Kuo, Site 0019    +61293825828      
Australia, Victoria
Local Institution Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Site 0018         
Canada, Ontario
Local Institution Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Site 0003         
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Lillian Siu, Site 0002    4169462911      
Canada, Quebec
Local Institution Recruiting
Montreal, Quebec, Canada, H2X 3E4
Contact: Site 0024         
Sir Mortimer B Davis Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Wilson Miller, Site 0014    514340822224619      
France
Local Institution Recruiting
Marseille Cedex 5, France, 13385
Contact: Site 0021         
Local Institution Recruiting
Toulouse Cedex 9, France, 31059
Contact: Site 0008         
Local Institution Recruiting
Villejuif Cedex, France, 94805
Contact: Site 0007         
Germany
Klinikum Der Albrecht-Ludwigs-Universitat Recruiting
Freiburg, Germany, 79106
Contact: Cornelius Waller, Site 0016    +4976127032610      
Klinikum rechts der Isar der Technischen Universitat Muenchen Klinik und Poliklinik fur Innere Mediz Recruiting
Munich, Germany, 81675
Contact: Sylvie Lorenzen, Site 0015    +498941405145      
Italy
Instituto Nazionale Tumori Fondazione G. Pascale Recruiting
Napoli, Italy, 80131
Contact: Paolo Ascierto, Site 0012    +390815903236 000 0000000      
I.O.V. Istituto Oncologico Veneto Ircss Recruiting
Padova, Italy, Padova
Contact: Vittorina Zagonel, Site 0013    +390498215953 000 0000000      
Netherlands
Local Institution Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Site 0006         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02754141     History of Changes
Other Study ID Numbers: CA013-004
2016-000603-91 ( EudraCT Number )
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents