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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 : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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 Biological: Ipilimumab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 425 participants
Allocation: 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 6, 2017
Estimated Primary Completion Date : September 17, 2024
Estimated Study Completion Date : September 18, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1A: BMS-986249 Biological: BMS-986249
specified dose on specified day
Experimental: Part 1B: BMS-986249 + nivolumab (nivo) Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2A Arm C: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma
 Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2A Arm D: ipilimumab + nivo then nivo
Previously untreated unresectable stage III-IV melanoma
 Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
  • BMS 734016
Experimental: Part 2A Arm F: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma
 Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2B Cohort 1: BMS-986249 + nivo
Advanced hepatocellular carcinoma (HCC)
 Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2B Cohort 2: BMS-986249 + nivo
Metastatic castration-resistant prostate cancer (CRPC)
 Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2B Cohort 3: BMS-986249 + nivo
Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)
 Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2A Arm A: BMS-986249 + nivo then nivo
  • Previously untreated unresectable stage III-IV melanoma
  • Enrollment is closed for this Arm
 Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2A Arm B: BMS-986249 + nivo
  • Previously untreated unresectable stage III-IV melanoma
  • Enrollment is closed for this Arm
 Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2A Arm E: Nivo
  • Previously untreated unresectable stage III-IV melanoma
  • Enrollment is closed for this Arm
 Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 2.5 years ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 2.5 years ]
  3. Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 2.5 years ]
  4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 2.5 years ]
  5. Incidence of death [ Time Frame: Up to 4 years ]
  6. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 2.5 years ]
  7. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 2.5 years ]
  8. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 2.5 years ]
  9. Incidence of treatment-related Grade 3-5 AEs [ Time Frame: Within 24 weeks ]
  10. Objective Response Rate as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 2.5 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. Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg) [ Time Frame: Up to 2 years ]
  8. Terminal serum half-life if data permit (T-HALF) [ Time Frame: Up to 2 years ]
  9. 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 ]
  10. Total body clearance (CLT) [ Time Frame: Up to 2 years ]
  11. Objective Response Rate (ORR) [ Time Frame: Up to 4 years ]
  12. Duration of response (DOR) [ Time Frame: Up to 4 years ]
  13. Progression-Free survival (PFS) [ Time Frame: Up to 4 years ]
  14. Time to response (TTR) [ Time Frame: Up to 4 years ]
  15. Incidence of Adverse Events (AEs) in Part 2 of Study [ Time Frame: Up to 2.5 years ]
  16. Incidence of Serious Adverse Events (SAEs) in Part 2 of Study [ Time Frame: Up to 2.5 years ]
  17. Incidence of AEs leading to discontinuation in Part 2 of study [ Time Frame: Up to 2.5 years ]
  18. Incidence of death in Part 2 of study [ Time Frame: Up to 4 years ]
  19. Incidence of clinically significant changes in clinical laboratory results: Hematology tests in Part 2 of study [ Time Frame: Up to 2.5 years ]
  20. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests in Part 2 of study [ Time Frame: Up to 2.5 years ]
  21. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests in Part 2 of study [ Time Frame: Up to 2.5 years ]
  22. Time to Deterioration (TTD) in Part 2 of study [ Time Frame: Up to 4 Years ]

Eligibility Criteria
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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
  • Some 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
  • Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants
  • Understand and sign an IRB/IEC-approved ICF prior to any study-specific evaluation
  • Willing and able to comply with all study procedures

Exclusion Criteria:

  • Primary CNS malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded
  • Other active malignancy requiring concurrent intervention
  • Prior organ allograft
  • Active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria apply

Contacts and Locations
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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 #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03369223    
Other Study ID Numbers: CA030-001
2018-000416-21 ( EudraCT Number )
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021

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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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Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents