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A Safety Study of Lirilumab in Combination With Nivolumab or in Combination With Nivolumab and Ipilimumab in Advanced and/or Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03203876
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : March 10, 2022
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
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 lirilumab in combination with nivolumab or in combination with nivolumab and ipilimumab is safe in the treatment of advanced and/or metastatic solid tumors

Condition or disease Intervention/treatment Phase
Advanced Cancer Biological: Lirilumab Biological: Nivolumab Biological: Ipilimumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of the Safety and Pharmacokinetics of Anti-KIR Monoclonal Antibody (Lirilumab, BMS-986015) in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab,BMS-936558) or in Combination With Nivolumab and Anti-CTLA-4 Monoclonal Antibody (Ipilimumab, BMS-734016) in Advanced and/or Metastatic Solid Tumors
Actual Study Start Date : July 14, 2017
Actual Primary Completion Date : August 6, 2020
Actual Study Completion Date : August 6, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part One Combination Therapy
Lirilumab and Nivolumab
 Biological: Lirilumab
Specified dose on specified days
Other Name: BMS-986015

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Part 2 Combination Therapy
Lirilumab, Nivolumab and Ipilimumab
 Biological: Lirilumab
Specified dose on specified days
Other Name: BMS-986015

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

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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of dose-limiting toxicity (DLT) [ Time Frame: Up to two years ]
    To assess the safety and tolerability of lirilumab in combination with nivolumab

  2. Incidence of adverse events (AEs) [ Time Frame: Up to two years ]
    To assess the safety and tolerability of lirilumab in combination with nivolumab

  3. Incidence of serious adverse events (SAEs) [ Time Frame: Up to two years ]
    To assess the safety and tolerability of lirilumab in combination with nivolumab

  4. Incidence of death [ Time Frame: Up to two years ]
    To assess the safety and tolerability of lirilumab in combination with nivolumab

  5. Frequency of laboratory test toxicity grade shifting from baseline [ Time Frame: Up to two years ]
    To assess the safety and tolerability of lirilumab in combination with nivolumab

  6. Incidence of AEs leading to discontinuation [ Time Frame: Up to two years ]
    To assess the safety and tolerability of lirilumab in combination with nivolumab


Secondary Outcome Measures :
  1. Incidence of dose-limiting toxicity (DLT) [ Time Frame: Up to two years ]
    To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab

  2. Incidence of adverse events (AEs) [ Time Frame: Up to two years ]
    To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab

  3. Incidence of serious adverse events (SAEs) [ Time Frame: Up to two years ]
    To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab

  4. Incidence of death [ Time Frame: Up to two years ]
    To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab

  5. Frequency of laboratory test toxicity grade shifting from baseline [ Time Frame: Up to two years ]
    To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab

  6. Maximum serum observed concentration (Cmax) [ Time Frame: Up to two years ]
    To characterize the Pharmacokinetic (PK) of lirilumab given in combination with nivolumab

  7. Time of maximum observed serum concentration (Tmax) [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab

  8. Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab

  9. Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab

  10. Trough observed serum concentration (Ctrough) [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab

  11. Area under the serum concentration-time curve in one dosing interval [AUC(TAU)] [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab

  12. Clearance (CL) [ Time Frame: Up to two years ]
    To characterize the PK and immunogenicity of lirilumab given in combination with nivolumab

  13. Volume of distribution at steady state (Vss) [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab

  14. Ratio of an exposure measure at steady-state to that after the first dose (AI) [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab

  15. Half-life (T-HALF) [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab

  16. Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALF eff) [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab

  17. Best overall response (BOR) [ Time Frame: Up to two years ]
    To assess the preliminary anti-tumor activity

  18. Duration of response (DOR) [ Time Frame: Up to two years ]
    To assess the preliminary anti-tumor activity

  19. Incidence of anti-drug antibody (ADA) [ Time Frame: Up to two years ]
    To characterize immunogenicity

  20. Incidence of AEs leading to discontinuation [ Time Frame: Up to two years ]
    To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab

  21. Maximum serum observed concentration (Cmax) [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  22. Time of maximum observed serum concentration (Tmax) [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  23. Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  24. Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  25. Trough observed serum concentration (Ctrough) [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  26. Area under the serum concentration-time curve in one dosing interval [AUC(TAU)] [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  27. Clearance (CL) [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  28. Volume of distribution at steady state (Vss) [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  29. Ratio of an exposure measure at steady-state to that after the first dose (AI) [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  30. Half-life (T-HALF) [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  31. Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALF eff) [ Time Frame: Up to two years ]
    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

  • Participants must have histologic or cytologic confirmation of a solid malignancy that is advanced (metastatic and/or unresectable)
  • Presence of at least 1 lesion with measurable disease as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) criteria for response assessment
  • The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Participants with untreated central nervous system (CNS) metastases
  • Participants with an active, known, or suspected autoimmune disease
  • Uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could 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): NCT03203876


Locations
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Japan
Local Institution
Kashiwa-shi, Chiba, Japan, 2778577
Local Institution
Kobe-shi, Hyogo, Japan, 6500017
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
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: NCT03203876    
Other Study ID Numbers: CA223-030
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action