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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01714739
First received: October 24, 2012
Last updated: April 17, 2017
Last verified: April 2017

October 24, 2012
April 17, 2017
October 2012
July 2019   (Final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
  • Objective response rate (ORR) [ Time Frame: Approximately 3 years ]
  • Safety and tolerability of BMS-986015 given in combination with BMS-936558 as measured by incidence of adverse events [ Time Frame: Approximately up to 27 months ]
  • Safety and tolerability of BMS-986015 given in combination with BMS-936558 as measured by incidence of clinical laboratory test abnormalities including hematology and serum chemistry, and thyroid panel abnormalities [ Time Frame: Approximately up to 27 months ]
Complete list of historical versions of study NCT01714739 on ClinicalTrials.gov Archive Site
  • Maximum observed serum concentration (Cmax) of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
  • Time of maximum observed serum concentration (Tmax) of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
  • 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 ]
  • 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 ]
  • Trough observed serum concentration (Ctrough) of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
  • 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 ]
  • Clearance (CL) of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
  • Volume of distribution at steady state (Vss) of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
  • Half-life (t1/2) of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
  • Anti-drug antibody (ADA) response to BMS-986015 in combination with BMS-936558 or BMS-734016 [ Time Frame: Approximately 27 months ]
  • Overall survival (OS) [ Time Frame: Approximately 3 years ]
  • Progression-Free Survival (PFS) [ Time Frame: Approximately 3 years ]
  • Duration of response (DOR) [ Time Frame: Approximately 3 years ]
  • Anti-tumor activity will be based on Best overall response (BOR), Objective response rate (ORR), Duration of Response (DOR) and Progression-Free Survival Rate (PFSR) using Immune-related RECIST (irRECIST) and RECIST v1.1 [ Time Frame: Approximately up to 27 months ]

    Every 8 weeks during the Treatment Period (Cycle 1 Day 1 through Cycle 12 Day 56), and once during clinical follow-up

    RECIST = Response Evaluation Criteria In Solid Tumors

  • Maximum observed serum concentration (Cmax) of BMS-986015 derived from serum concentration versus time [ Time Frame: 13 time points up to 27 months ]
  • Time of maximum observed serum concentration (Tmax) of BMS-986015 derived from serum concentration versus time [ Time Frame: 13 time points up to 27 months ]
  • 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: 13 time points up to 27 months ]
  • 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: 13 time points up to 27 months ]
  • Trough observed serum concentration (Ctrough) of BMS-986015 derived from serum concentration versus time [ Time Frame: 13 time points up to 27 months ]
  • Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986015 derived from serum concentration versus time [ Time Frame: 13 time points up to 27 months ]
  • Clearance (CL) of BMS-986015 derived from serum concentration versus time [ Time Frame: 13 time points up to 27 months ]
  • Volume of distribution at steady state (Vss) of BMS-986015 derived from serum concentration versus time [ Time Frame: 13 time points up to 27 months ]
  • Half-life (t1/2) of BMS-986015 derived from serum concentration versus time [ Time Frame: 13 time points up to 27 months ]
  • End of infusion of BMS-936558 derived from serum concentration versus time [ Time Frame: 9 time points up to 27 months ]
  • Trough observed concentration (Cmin) of BMS-936558 derived from serum concentration versus time [ Time Frame: 9 time points up to 27 months ]
  • Immunogenicity of BMS-986015 and BMS-936558 measured by occurrence of specific anti-drug antibodies to BMS-986015 and BMS-936558 [ Time Frame: Approximately up to 27 months ]
  • Measures of Tumor infiltrating lymphocyte(s) (TILs), Programmed Death Ligand-1 (PD-L1) and Human Leukocyte Antigen (HLA) Class I expression using immunohistochemistry [ Time Frame: Screening (Day -28 to -1) and Day 112 ]
Not Provided
Not Provided
 
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
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
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
CANCER,NOS
  • 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
  • Experimental: Part 1
    Dose Escalation and Initial Signal Detection in Multiple Solid Tumors - Nivolumab with Lirilumab
    Interventions:
    • Drug: Lirilumab
    • Drug: Nivolumab
  • Experimental: Part 2 and 3: Cohort Expansion
    In platinum-refractory recurrent or metastatic SCCHN - Nivolumab with or without Lirilumab
    Interventions:
    • Drug: Lirilumab
    • Drug: Nivolumab
  • Experimental: Part 4: Cohort Expansion
    Additional Signal Detection in Solid Tumors - Nivolumab with Lirilumab
    Interventions:
    • Drug: Lirilumab
    • Drug: Nivolumab
  • Experimental: Part 5 and 6
    Safety Lead-In and Additional Signal Detection in Solid Tumors -- Nivolumab Plus Ipilimumab with Lirilumab
    Interventions:
    • Drug: Lirilumab
    • Drug: Nivolumab
    • Drug: Ipilimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
650
July 2019
July 2019   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
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 #.
United States,   Canada,   France,   Germany,   Italy,   Singapore,   Switzerland
 
 
NCT01714739
CA223-001
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP