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

NCT ID: NCT01714739

Last Updated: 2023-02-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

337 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-07

Study Completion Date

2019-12-13

Brief Summary

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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.

Detailed Description

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Conditions

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CANCER,NOS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Part 1

Dose Escalation and Initial Signal Detection in Multiple Solid Tumors - Nivolumab with Lirilumab

Group Type EXPERIMENTAL

Lirilumab

Intervention Type DRUG

Specified dose on specified days.

Nivolumab

Intervention Type DRUG

Specified dose on specified days.

Part 2 and 3: Cohort Expansion

In platinum-refractory recurrent or metastatic SCCHN - Nivolumab with or without Lirilumab

Group Type EXPERIMENTAL

Lirilumab

Intervention Type DRUG

Specified dose on specified days.

Nivolumab

Intervention Type DRUG

Specified dose on specified days.

Part 4: Cohort Expansion

Additional Signal Detection in Solid Tumors - Nivolumab with Lirilumab (Study Part 4 Removed; No Subjects Enrolled)

Group Type EXPERIMENTAL

Lirilumab

Intervention Type DRUG

Specified dose on specified days.

Nivolumab

Intervention Type DRUG

Specified dose on specified days.

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)

Group Type EXPERIMENTAL

Lirilumab

Intervention Type DRUG

Specified dose on specified days.

Nivolumab

Intervention Type DRUG

Specified dose on specified days.

Ipilimumab

Intervention Type DRUG

Specified dose on specified days.

Interventions

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Lirilumab

Specified dose on specified days.

Intervention Type DRUG

Nivolumab

Specified dose on specified days.

Intervention Type DRUG

Ipilimumab

Specified dose on specified days.

Intervention Type DRUG

Other Intervention Names

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BMS-986015 IPH-2102 ANTI-KIR (Killer-cell Immunoglobulin-like Receptors) BMS-936558 ANTI-PD1 BMS-734016 Anti-CTLA4

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Ucsf

San Francisco, California, United States

Site Status

Florida Cancer Affiliates - Ocala

Ocala, Florida, United States

Site Status

University Of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Lutherville, Maryland, United States

Site Status

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

Providence Portland Med Ctr

Portland, Oregon, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

UPMC Eye and Ear Institute

Pittsburgh, Pennsylvania, United States

Site Status

West Cancer Center

Germantown, Tennessee, United States

Site Status

Texas Oncology-Central Austin Cancer Center

Austin, Texas, United States

Site Status

University Of Texas Medical Branch Of Galveston

Galveston, Texas, United States

Site Status

University Of Washington

Seattle, Washington, United States

Site Status

Juravinski Cancer Center

Hamilton, Ontario, Canada

Site Status

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

Local Institution

Bordeaux, , France

Site Status

Local Institution

Lyon, , France

Site Status

Local Institution

Nice, , France

Site Status

Local Institution

Paris, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

IRCCS Istituto Nazionale Tumori Milano

Milan, MI, Italy

Site Status

Local Institution

Siena, , Italy

Site Status

Local Institution

Barcelona, , Spain

Site Status

Local Institution - 0038

Madrid, , Spain

Site Status

Local Institution

Madrid, , Spain

Site Status

Kantonsspital Graubuenden

Chur, , Switzerland

Site Status

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status

Countries

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United States Canada France Italy Spain Switzerland

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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CA223-001

Identifier Type: -

Identifier Source: org_study_id

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