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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
337

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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