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A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

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ClinicalTrials.gov Identifier: NCT03400332
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.

Condition or disease Intervention/treatment Phase
Cancer Drug: BMS-986253 Biological: Nivolumab Biological: Ipilimumab Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : June 8, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1A: BMS-986253 + nivolumab Drug: BMS-986253
Specified dose on specified days

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

Experimental: Part 1B: BMS-986253 + nivolumab Drug: BMS-986253
Specified dose on specified days

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

Experimental: Part 1C: BMS-986253 + nivolumab + ipilimumab Drug: BMS-986253
Specified dose on specified days

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

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • YERVOY

Experimental: Part 2A: BMS-986253 + nivolumab + ipilimumab Drug: BMS-986253
Specified dose on specified days

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

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • YERVOY

Placebo Comparator: Part 2B: Placebo + nivolumab + ipilimumab Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • YERVOY

Other: Placebo
Specified dose on specified days




Primary Outcome Measures :
  1. Incidence of adverse events (AE) [ Time Frame: Approximately 5 years ]
    Part 1

  2. Incidence of serious adverse events (SAE) [ Time Frame: Approximately 5 years ]
    Part 1

  3. Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria [ Time Frame: Approximately 5 years ]
    Part 1

  4. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 5 years ]
    Part 1

  5. Incidence of deaths [ Time Frame: Approximately 5 years ]
    Part 1

  6. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Approximately 5 years ]
    Part 1

  7. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Approximately 5 years ]
    Part 1

  8. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Approximately 5 years ]
    Part 1

  9. Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Approximately 5 years ]
    Part 2, participants with advanced melanoma, selected by baseline serum interleukin-8 (IL-8) level using RECIST v1.1


Secondary Outcome Measures :
  1. Objective response rate (ORR) based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2

  2. Median duration of response (mDOR) per response evaluation criteria in solid tumors (RECIST) v1.1 [ Time Frame: Approximately 5 years ]
    Part 1

  3. Incidence of anti-drug antibody (ADA) to BMS-986253 [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2

  4. Serum biomarker concentration [ Time Frame: Approximately 5 years ]
    Part 1

  5. Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2

  6. Time of maximum observed serum concentration (Tmax) [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2

  7. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2

  8. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2

  9. Observed serum concentration at the end of a dosing interval (CTAU) [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2

  10. Trough observed serum concentration at the end of the dosing interval (CTROUGH) [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2

  11. Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Approximately 5 years ]
    Part 2, participants with advanced melanoma, using RECIST v1.1 (regardless of baseline serum IL-8 levels)

  12. Overall Survival (OS) [ Time Frame: Approximately 5 years ]
    Part 2

  13. Incidence of AEs [ Time Frame: Approximately 5 years ]
    Part 2

  14. Incidence of SAEs [ Time Frame: Approximately 5 years ]
    Part 2

  15. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 5 years ]
    Part 2

  16. Incidence of death [ Time Frame: Approximately 5 years ]
    Part 2

  17. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Approximately 5 years ]
    Part 2

  18. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Approximately 5 years ]
    Part 2

  19. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Approximately 5 years ]
    Part 2



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 per RECIST v1.1
  • At least 1 lesion accessible for biopsy
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1

Exclusion Criteria:

  • Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
  • Participants with active, known or suspected autoimmune disease
  • Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
  • Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
  • Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy

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): NCT03400332


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
Show Show 51 study locations
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: NCT03400332    
Other Study ID Numbers: CA027-002
2018-000340-26 ( EudraCT Number )
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021

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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
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents