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

December 10, 2020 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

337

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Center
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
  • France
      • Bordeaux, France, 33075
        • Local Institution
      • Lyon Cedex 08, France, 69373
        • Local Institution
      • Nice Cedex 2, France, 06189
        • Local Institution
      • Paris, France, 75005
        • Local Institution
      • Villejuif Cedex, France, 94805
        • Institut Gustave Roussy
  • Italy
      • Siena, Italy, 53100
        • Local Institution
    • MI
      • Milano, MI, Italy, 20133
        • IRCCS Istituto Nazionale Tumori Milano
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution
      • Madrid, Spain, 28034
        • Local Institution
      • Madrid, Spain, 28050
        • Local Institution
  • Switzerland
      • Chur, Switzerland, 7000
        • Kantonsspital Graubuenden
      • Lausanne, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois
  • United States
    • California
      • San Francisco, California, United States, 94115
        • UCSF
    • Florida
      • Ocala, Florida, United States, 34471
        • Florida Cancer Affiliates - Ocala
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Med Ctr
      • Boston, Massachusetts, United States, 02215
        • Massachusetts General Hospital
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Med Ctr
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Eye and Ear Institute
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • West Cancer Center
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Oncology-Central Austin Cancer Center
      • Galveston, Texas, United States, 77555
        • University Of Texas Medical Branch Of Galveston
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Approximately 3 years
Objective response rate (ORR)
Time Frame: Approximately 3 years
Approximately 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum observed serum concentration (Cmax) of BMS-986015 derived from serum concentration versus time
Time Frame: Approximately 27 months
Approximately 27 months
Time of maximum observed serum concentration (Tmax) of BMS-986015 derived from serum concentration versus time
Time Frame: Approximately 27 months
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
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
Approximately 27 months
Trough observed serum concentration (Ctrough) of BMS-986015 derived from serum concentration versus time
Time Frame: Approximately 27 months
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
Approximately 27 months
Clearance (CL) of BMS-986015 derived from serum concentration versus time
Time Frame: Approximately 27 months
Approximately 27 months
Volume of distribution at steady state (Vss) of BMS-986015 derived from serum concentration versus time
Time Frame: Approximately 27 months
Approximately 27 months
Half-life (t1/2) of BMS-986015 derived from serum concentration versus time
Time Frame: Approximately 27 months
Approximately 27 months
Anti-drug antibody (ADA) response to BMS-986015 in combination with BMS-936558 or BMS-734016
Time Frame: Approximately 27 months
Approximately 27 months
Overall survival (OS)
Time Frame: Approximately 3 years
Approximately 3 years
Progression-Free Survival (PFS)
Time Frame: Approximately 3 years
Approximately 3 years
Duration of response (DOR)
Time Frame: Approximately 3 years
Approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2012

Primary Completion (Actual)

December 13, 2019

Study Completion (Actual)

December 13, 2019

Study Registration Dates

First Submitted

October 24, 2012

First Submitted That Met QC Criteria

October 24, 2012

First Posted (Estimate)

October 26, 2012

Study Record Updates

Last Update Posted (Actual)

December 14, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA223-001

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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