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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 : March 16, 2018
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
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm A
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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:

  • 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

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 #.

United States, Colorado
Local Institution Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Site 0005         
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: Charles Drake, Site 0002         
Local Institution Not yet recruiting
New York, New York, United States, 10065
Contact: Site 0003         
United States, Pennsylvania
Local Institution Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site 0004         
Sponsors and Collaborators
Bristol-Myers Squibb
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
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 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:
Antineoplastic Agents
Immunologic Factors
Antibodies, Monoclonal
Physiological Effects of Drugs

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