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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
  Purpose
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 Intervention Phase
CANCER,NOS
Drug: Lirilumab
Drug: Nivolumab
Drug: Ipilimumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 650
Study Start Date: October 2012
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714739

Contacts
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 #.

  Show 26 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01714739     History of Changes
Other Study ID Numbers: CA223-001
Study First Received: October 24, 2012
Last Updated: April 17, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nivolumab
Antibodies, Monoclonal
Immunoglobulins
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2017