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An Investigational Immunotherapy Study of BMS-986249 Alone and in Combination With Nivolumab in Solid Cancers That Are Advanced or Have Spread

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ClinicalTrials.gov Identifier: NCT03369223
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

Condition or disease Intervention/treatment Phase
Advanced Cancer Biological: BMS-986249 Biological: Nivolumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors
Actual Study Start Date : December 5, 2017
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Arm A
BMS-986249
Biological: BMS-986249
specified dose on specified day

Experimental: Arm B
BMS-986249 in combination with nivolumab
Biological: BMS-986249
specified dose on specified day

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




Primary Outcome Measures :
  1. Incidence of Adverse Events (AE) [ Time Frame: up to 4 years ]
    Safety and tolerability as measured by incidence of AEs

  2. Incidence of Serious Adverse Events (SAE) [ Time Frame: up to 4 years ]
    Safety and tolerability as measured by incidence of AEs

  3. Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria [ Time Frame: up to 4 years ]
  4. Incidence of AEs leading to discontinuation [ Time Frame: up to 4 years ]
  5. Incidence of death [ Time Frame: up to 4 years ]
  6. Incidence of Laboratory abnormalities [ Time Frame: up to 4 years ]

Secondary Outcome Measures :
  1. Cmax (Maximum observed serum concentration) [ Time Frame: up to 2 years ]
  2. Tmax (Time of maximum observed concentration) [ Time Frame: up to 2 years ]
  3. AUC(0-T) (Area under the serum concentration-time curve from time zero to time of last quantifiable concentration) [ Time Frame: up to 2 years ]
  4. AUC(TAU) (Area under the concentration-time curve in 1 dosing interval) [ Time Frame: up to 2 years ]
  5. Ctau (Observed concentration at the end of a dosing interval) [ Time Frame: up to 2 years ]
  6. Ctrough (Trough observed concentrations) [ Time Frame: up to 2 years ]
  7. Best overall response (BOR) [ Time Frame: up to 4 years ]
    assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  8. Duration of response (DOR) [ Time Frame: up to 4 years ]
  9. Progression-Free survival (PFS) [ Time Frame: up to 4 years ]
  10. Time to response (TTR) [ Time Frame: up to 4 years ]
  11. Total body clearance (CLT) [ Time Frame: up to 2 years ]
  12. Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg) [ Time Frame: up to 2 years ]
  13. Terminal serum half-life if data permit (T-HALF) [ Time Frame: up to 2 years ]
  14. Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)] [ Time Frame: up to 2 years ]


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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:

  • Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies

Exclusion Criteria:

  • Participants with primary CNS malignancies or tumors with CNS metastases as the only site of disease, will be excluded
  • Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted
  • Participants with other active malignancy requiring concurrent intervention

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): NCT03369223


Contacts
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
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Bradley Corr, Site 0005         
Local Institution Not yet recruiting
Denver, Colorado, United States, 80218
Contact: Site 0006         
United States, Florida
Local Institution Not yet recruiting
Miami, Florida, United States, 33176
Contact: Site 0017         
United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Martin Gutierrez, Site 0001    551-996-5499      
United States, New York
Columbia University Medical Center (Cumc) Recruiting
New York, New York, United States, 10032
Contact: Mark Stein, Site 0002         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Claire Friedman, Site 0003         
United States, Oregon
Local Institution Not yet recruiting
Eugene, Oregon, United States, 97401
Contact: Site 0013         
United States, Pennsylvania
Local Institution Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site 0004         
United States, South Carolina
Greenville Health System Recruiting
Greenville, South Carolina, United States, 29605
Contact: William Edenfield, Site 0008         
United States, Texas
Texas Oncology- Austin Midtown Recruiting
Austin, Texas, United States, 78705
Contact: Jason Melear, Site 0010         
Local Institution Not yet recruiting
Dallas, Texas, United States, 75246
Contact: Site 0009         
Local Institution Not yet recruiting
Houston, Texas, United States, 77030
Contact: Site 0021         
Texas Oncology-San Antonio Medical Center Recruiting
San Antonio, Texas, United States, 78240
Contact: Sridhar Beeram, Site 0016         
Texas Oncology, P.A. Recruiting
Tyler, Texas, United States, 75702
Contact: Donald Richards, Site 0011         
United States, Virginia
Local Institution Not yet recruiting
Fairfax, Virginia, United States, 22031
Contact: Site 0012         
Local Institution Not yet recruiting
Norfolk, Virginia, United States, 23502
Contact: Site 0007         
United States, Washington
Local Institution Not yet recruiting
Vancouver, Washington, United States, 98684
Contact: Site 0018         
Australia, New South Wales
Local Institution Not yet recruiting
North Sydney, New South Wales, Australia, 2060
Contact: Site 0015         
Australia, South Australia
Local Institution Not yet recruiting
Adelaide, South Australia, Australia, 5000
Contact: Site 0014         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03369223     History of Changes
Other Study ID Numbers: CA030-001
2018-000416-21 ( EudraCT Number )
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018

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

Keywords provided by Bristol-Myers Squibb:
Antibodies
Antineoplastic Agents
Immunologic Factors
Nivolumab
Antibodies, Monoclonal
Physiological Effects of Drugs

Additional relevant MeSH terms:
Antibodies
Antibodies, Monoclonal
Nivolumab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents