An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer

NCT ID: NCT02750514

Last Updated: 2021-03-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

295 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-09

Study Completion Date

2020-01-29

Brief Summary

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The purpose of this study is to determine whether Nivolumab, in combination with other therapies, is effective in patients with advanced Non-Small Cell lung cancer

Detailed Description

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Conditions

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Advanced Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nivolumab

Nivolumab Monotherapy - Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator

Group Type ACTIVE_COMPARATOR

Nivolumab

Intervention Type BIOLOGICAL

Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.

Nivolumab & Dasatinib

Nivolumab in combination with Dasatinib

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.

Dasatinib

Intervention Type DRUG

Nivolumab & Relatlimab

Nivolumab in combination with Relatlimab

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.

Relatlimab

Intervention Type BIOLOGICAL

Nivolumab & Ipilimumab

Nivolumab in combination with Ipilimumab

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.

Ipilimumab

Intervention Type BIOLOGICAL

Nivolumab & BMS-986205

Nivolumab in combination with BMS- 986205

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.

BMS-986205

Intervention Type DRUG

Specified dose on specified days

Interventions

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Nivolumab

Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.

Intervention Type BIOLOGICAL

Dasatinib

Intervention Type DRUG

Relatlimab

Intervention Type BIOLOGICAL

Ipilimumab

Intervention Type BIOLOGICAL

BMS-986205

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-936558 MDX-1106 OPDIVO BMS-354825 SPRYCEL BMS-986016 BMS-734016 Yervoy

Eligibility Criteria

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Inclusion Criteria

* Advanced Non Small Cell Lung Cancer (NSCLC)
* Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 1
* Life expectancy of at least 3 months from most recent chemotherapy or immunotherapy treatment
* Must have at least 1 lesion with measurable disease

Exclusion Criteria

* Subjects with certain mutations that have not been treated with a targeted therapy prior to enrollment
* Subjects who need daily oxygen therapy
* People with autoimmune disease
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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City of Hope National Medical Center

Duarte, California, United States

Site Status

University of Southern California (USC)

Los Angeles, California, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

University of Californa, Los Angeles (UCLA)

Los Angeles, California, United States

Site Status

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Site Status

University of California San Diego

San Diego, California, United States

Site Status

University of Colorado Denver

Aurora, Colorado, United States

Site Status

Yale Cancer Center

New Haven, Connecticut, United States

Site Status

University of Kansas Cancer Center

Westwood, Kansas, United States

Site Status

University of Maryland - Marlene and Stewart Greenebaum Cancer Center

Baltimore, Maryland, United States

Site Status

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Dana Farber/Harvard Cancer Center

Boston, Massachusetts, United States

Site Status

University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Ce

Ann Arbor, Michigan, United States

Site Status

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Washington University, The Center for Advanced Medicine

St Louis, Missouri, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Univ of NC Shool of Medicine

Chapel Hill, North Carolina, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

Northwest Cancer Specialists

Portland, Oregon, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

The West Clinic, P.C. d/b/a West Cancer Center

Germantown, Tennessee, United States

Site Status

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Site Status

Sammons Cancer Center (Uso)

Dallas, Texas, United States

Site Status

Texas Oncology, P.A.

Fort Worth, Texas, United States

Site Status

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Us Oncology

Tyler, Texas, United States

Site Status

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Site Status

University of Washington-Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

Local Institution

Clayton, Victoria, Australia

Site Status

Local Institution

Salzburg, , Austria

Site Status

Juravinski Cancer Centre, Hamilton Health Sciences-Mcmaster Univeristy's Faculty Of Health Sciences

Hamilton, Ontario, Canada

Site Status

University Of Ottawa - The Ottawa Hospital Cancer centre

Ottawa, Ontario, Canada

Site Status

Local Institution

Edmonton, , Canada

Site Status

Local Institution

Paris, , France

Site Status

Local Institution

Toulouse, , France

Site Status

Local Institution

Villejuif, , France

Site Status

Local Institution

Milan, , Italy

Site Status

Local Institution

Milan, , Italy

Site Status

Local Institution

Rozzano, , Italy

Site Status

Local Institution

Madrid, , Spain

Site Status

Local Institution

Madrid, , Spain

Site Status

Local Institution

Pamplona, , Spain

Site Status

Local Institution

Lausanne, , Switzerland

Site Status

Countries

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United States Australia Austria Canada France Italy Spain Switzerland

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

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Other Identifiers

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CA018-001

Identifier Type: -

Identifier Source: org_study_id

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