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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 : January 31, 2019
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

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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 ]


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:

  • 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
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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 #.

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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: 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: January 31, 2019
Last Verified: January 2019

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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:
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Antibodies
Nivolumab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents