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A Study of an Anti-KIR Antibody Lirilumab in Combination With an Anti-PD1 Antibody Nivolumab and Nivolumab Plus an Anti-CTLA-4 Ipilimumab Antibody in Patients With Advanced 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: NCT01714739
Recruitment Status : Completed
First Posted : October 26, 2012
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
To assess the safety and tolerability and preliminary anti-tumor activity of lirilumab (BMS-986015) given in combination with nivolumab (BMS-936558) and to identify dose limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination. In addition, to assess the combinations of lirilumab and nivolumab or lirilumab and nivolumab plus ipilimumab (BMS-734016) in subjects with advanced (metastatic and/or unresectable) refractory solid tumors.

Condition or disease Intervention/treatment Phase
CANCER,NOS Drug: Lirilumab Drug: Nivolumab Drug: Ipilimumab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 337 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of the Combination of Lirilumab (Anti-KIR) Plus Nivolumab (Anti-PD-1) or Lirilumab Plus Nivolumab and Ipilimumab in Advanced Refractory Solid Tumors
Actual Study Start Date : October 7, 2012
Actual Primary Completion Date : December 13, 2019
Actual Study Completion Date : December 13, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1
Dose Escalation and Initial Signal Detection in Multiple Solid Tumors - Nivolumab with Lirilumab
 Drug: Lirilumab
Specified dose on specified days.
Other Names:
  • BMS-986015
  • IPH-2102
  • ANTI-KIR (Killer-cell Immunoglobulin-like Receptors)

Drug: Nivolumab
Specified dose on specified days.
Other Names:
  • BMS-936558
  • ANTI-PD1
Experimental: Part 2 and 3: Cohort Expansion
In platinum-refractory recurrent or metastatic SCCHN - Nivolumab with or without Lirilumab
 Drug: Lirilumab
Specified dose on specified days.
Other Names:
  • BMS-986015
  • IPH-2102
  • ANTI-KIR (Killer-cell Immunoglobulin-like Receptors)

Drug: Nivolumab
Specified dose on specified days.
Other Names:
  • BMS-936558
  • ANTI-PD1
Experimental: Part 4: Cohort Expansion
Additional Signal Detection in Solid Tumors - Nivolumab with Lirilumab (Study Part 4 Removed; No Subjects Enrolled)
 Drug: Lirilumab
Specified dose on specified days.
Other Names:
  • BMS-986015
  • IPH-2102
  • ANTI-KIR (Killer-cell Immunoglobulin-like Receptors)

Drug: Nivolumab
Specified dose on specified days.
Other Names:
  • BMS-936558
  • ANTI-PD1
Experimental: Part 5 and 6
Safety Lead-In and Additional Signal Detection in Solid Tumors -- Nivolumab Plus Ipilimumab with Lirilumab (Study Part 6 Removed; No Subjects Enrolled)
 Drug: Lirilumab
Specified dose on specified days.
Other Names:
  • BMS-986015
  • IPH-2102
  • ANTI-KIR (Killer-cell Immunoglobulin-like Receptors)

Drug: Nivolumab
Specified dose on specified days.
Other Names:
  • BMS-936558
  • ANTI-PD1

Drug: Ipilimumab
Specified dose on specified days.
Other Names:
  • BMS-734016
  • Anti-CTLA4


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability of BMS-986015 given in combination with BMS-936558 or BMS-936558 plus BMS-734016 as measured by incidence of adverse events [ Time Frame: Approximately 3 years ]
  2. Safety and tolerability of BMS-986015 given in combination with BMS-936558 or BMS-936558 plus BMS-734016 as measured by incidence of clinical laboratory test abnormalities including hematology, serum chemistry, and thyroid panel abnormalities [ Time Frame: Approximately 3 years ]
  3. Objective response rate (ORR) [ Time Frame: Approximately 3 years ]

Secondary Outcome Measures :
  1. Maximum observed serum concentration (Cmax) of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
  2. Time of maximum observed serum concentration (Tmax) of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
  3. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
  4. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
  5. Trough observed serum concentration (Ctrough) of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
  6. Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
  7. Clearance (CL) of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
  8. Volume of distribution at steady state (Vss) of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
  9. Half-life (t1/2) of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
  10. Anti-drug antibody (ADA) response to BMS-986015 in combination with BMS-936558 or BMS-734016 [ Time Frame: Approximately 27 months ]
  11. Overall survival (OS) [ Time Frame: Approximately 3 years ]
  12. Progression-Free Survival (PFS) [ Time Frame: Approximately 3 years ]
  13. Duration of response (DOR) [ Time Frame: Approximately 3 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 BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • During dose escalation, subjects with advanced solid tumors (except for primary CNS metastases) that have progressed following at least one standard regimen
  • During cohort expansion, subjects with various solid tumors that have received at least one and no more than 5 prior treatment regimens
  • Subjects must have measurable disease
  • Subject must consent to provide previously collected tumor tissue
  • Women and men ≥18 years of age with performance status of 0 or 1
  • At least 4 weeks since any previous treatment for cancer

Exclusion Criteria:

  • Active or chronic autoimmune diseases
  • Uncontrolled or significant cardiovascular disease
  • Chronic hepatitis (except for subjects with hepatocellular carcinoma)
  • Active infection
  • Active Central nervous system (CNS) metastases
  • Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome((HIV/AIDS)
  • Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)

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): NCT01714739


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: NCT01714739    
Other Study ID Numbers: CA223-001
First Posted: October 26, 2012    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020

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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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Neoplasms
Nivolumab
Ipilimumab
Immunoglobulins
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs