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A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

NCT ID: NCT02713867

Last Updated: 2023-02-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

363 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-24

Study Completion Date

2022-01-18

Brief Summary

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The primary objective of this study is to compare PFS (progression-free survival) rate at 6 months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and Sq).

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Detailed Description

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Conditions

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Lung 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 240 mg

Nivolumab 240 mg Every 2 Weeks

Group Type ACTIVE_COMPARATOR

Nivolumab

Intervention Type BIOLOGICAL

Nivolumab 480 mg

Nivolumab 480 mg Every 4 Weeks

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Interventions

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Nivolumab

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically documented Squamous or non-Squamous Non-small cell lung cancer (NSCLC) (Stage IIIB/IV), or recurrent or progressive disease following multimodal therapy
* Patients must have received pre-study nivolumab for up to 12 months and have 2 consecutive tumor assessments confirming Complete response (CR), Partial response (PR), or Stable disease (SD)
* Measurable disease before start of pre-study nivolumab treatment
* Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2

Exclusion Criteria

* Carcinomatous meningitis
* Untreated, symptomatic Central nervous system (CNS) metastases
* Symptomatic interstitial lung 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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Local Institution - 0004

Birmingham, Alabama, United States

Site Status

Local Institution - 0030

Phoenix, Arizona, United States

Site Status

Local Institution - 0041

Phoenix, Arizona, United States

Site Status

CBCC Global Research, Inc.

Bakersfield, California, United States

Site Status

Southern California Permanente Medical Group

Bellflower, California, United States

Site Status

St Jude Hospital Yorba Linda

Fullerton, California, United States

Site Status

Local Institution - 0046

Los Angeles, California, United States

Site Status

Local Institution - 0126

Orange, California, United States

Site Status

Torrance Health Association

Redondo Beach, California, United States

Site Status

Sharp Memorial Hospital

San Diego, California, United States

Site Status

Local Institution - 0010

Santa Barbara, California, United States

Site Status

Local Institution - 0044

Santa Maria, California, United States

Site Status

Local Institution - 0130

Vallejo, California, United States

Site Status

Local Institution - 0017

Denver, Colorado, United States

Site Status

Local Institution - 0122

Fort Collins, Colorado, United States

Site Status

Local Institution - 0038

Fort Myers, Florida, United States

Site Status

Local Institution - 0089

Hollywood, Florida, United States

Site Status

Local Institution - 0026

Ocala, Florida, United States

Site Status

Local Institution - 0001

Pensacola, Florida, United States

Site Status

Local Institution - 0039

St. Petersburg, Florida, United States

Site Status

Local Institution - 0008

Athens, Georgia, United States

Site Status

Local Institution - 0142

Columbus, Georgia, United States

Site Status

Local Institution - 0121

Marietta, Georgia, United States

Site Status

Ingalls Health System

Harvey, Illinois, United States

Site Status

Local Institution - 0098

Niles, Illinois, United States

Site Status

Local Institution - 0100

Peoria, Illinois, United States

Site Status

Local Institution - 0143

Urbana, Illinois, United States

Site Status

Local Institution - 0099

Fort Wayne, Indiana, United States

Site Status

Local Institution - 0050

Fort Wayne, Indiana, United States

Site Status

Innova Schar Cancer Institute

Indianapolis, Indiana, United States

Site Status

Local Institution - 0123

Wichita, Kansas, United States

Site Status

Local Institution - 0112

Paducah, Kentucky, United States

Site Status

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Site Status

Local Institution - 0137

New Orleans, Louisiana, United States

Site Status

Local Institution - 0109

Brewer, Maine, United States

Site Status

Local Institution - 0042

Bethesda, Maryland, United States

Site Status

Local Institution - 0125

Springfield, Massachusetts, United States

Site Status

Local Institution - 0136

Southfield, Michigan, United States

Site Status

Local Institution - 0120

Minneapolis, Minnesota, United States

Site Status

Local Institution - 0116

Tupelo, Mississippi, United States

Site Status

Mercy Medical Research Institute

Springfield, Missouri, United States

Site Status

Local Institution - 0014

Omaha, Nebraska, United States

Site Status

Local Institution - 0141

Lebanon, New Hampshire, United States

Site Status

Local Institution - 0035

Albany, New York, United States

Site Status

Local Institution - 0013

Johnson City, New York, United States

Site Status

Local Institution - 0127

Pinehurst, North Carolina, United States

Site Status

Hematology And Oncology Associates

Canton, Ohio, United States

Site Status

Local Institution - 0037

Cincinnati, Ohio, United States

Site Status

Local Institution - 0132

Cincinnati, Ohio, United States

Site Status

MetroHealth Cancer Care Center

Cleveland, Ohio, United States

Site Status

Local Institution - 0129

Massillon, Ohio, United States

Site Status

Hematology Oncology Consultants, Pc

Medford, Oregon, United States

Site Status

Local Institution - 0005

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution - 0020

Charleston, South Carolina, United States

Site Status

Local Institution - 0124

Sioux Falls, South Dakota, United States

Site Status

Jones Clinic PC

Germantown, Tennessee, United States

Site Status

Local Institution - 0036

Nashville, Tennessee, United States

Site Status

Local Institution - 0023

Abilene, Texas, United States

Site Status

Texas Oncology - Amarillo

Amarillo, Texas, United States

Site Status

Local Institution - 0011

Dallas, Texas, United States

Site Status

Local Institution - 0022

Dallas, Texas, United States

Site Status

Texas Oncology, P.A.

Denton, Texas, United States

Site Status

Texas Oncology, P.A.

El Paso, Texas, United States

Site Status

Local Institution - 0025

Flower Mound, Texas, United States

Site Status

Texas Oncology, P.A.

Houston, Texas, United States

Site Status

Texas Oncology, P.A.

Longview, Texas, United States

Site Status

Local Institution - 0119

Midland, Texas, United States

Site Status

Texas Oncology, P.A.

Plano, Texas, United States

Site Status

Texas Oncology, P.A.

San Antonio, Texas, United States

Site Status

Texas Oncology, P.A.

Sherman, Texas, United States

Site Status

Texas Oncology, P.A.

Sugar Land, Texas, United States

Site Status

Local Institution - 0034

Wichita Falls, Texas, United States

Site Status

Innova Schar Cancer Institute

Falls Church, Virginia, United States

Site Status

Shenandoah Oncology

Winchester, Virginia, United States

Site Status

Cancer Care Northwest

Spokane Valley, Washington, United States

Site Status

Local Institution - 0031

Vancouver, Washington, United States

Site Status

Yakima Valley Memorial Hospital/North Star Lodge

Yakima, Washington, United States

Site Status

Local Institution - 0052

St Leonards, New South Wales, Australia

Site Status

Local Institution - 0118

Waratah, New South Wales, Australia

Site Status

Local Institution - 0117

Westmead, New South Wales, Australia

Site Status

Local Institution - 0093

Woolloongabba, Queensland, Australia

Site Status

Local Institution - 0054

Bedford Park, South Australia, Australia

Site Status

Local Institution - 0056

Elizabeth Vale, South Australia, Australia

Site Status

Local Institution - 0055

Kurralta Park, South Australia, Australia

Site Status

Local Institution - 0057

Hobart, Tasmania, Australia

Site Status

Local Institution - 0053

Heidelberg, Victoria, Australia

Site Status

Local Institution - 0058

Murdoch, Western Australia, Australia

Site Status

Local Institution

Vienna, , Austria

Site Status

Local Institution - 0059

Newmarket, Ontario, Canada

Site Status

Local Institution - 0146

Laval, Quebec, Canada

Site Status

Local Institution - 0145

Montreal, Quebec, Canada

Site Status

Local Institution

Québec, Quebec, Canada

Site Status

Local Institution - 0060

Saint-Jérôme, Quebec, Canada

Site Status

Local Institution - 0081

Angers, , France

Site Status

Local Institution - 0105

Angers, , France

Site Status

Local Institution - 0080

Bayonne, , France

Site Status

Local Institution - 0076

Clermont-Ferrand, , France

Site Status

Local Institution - 0077

Le Mans, , France

Site Status

Local Institution - 0072

Mulhouse, , France

Site Status

Local Institution - 0078

Nîmes, , France

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Local Institution - 0095

Paris, , France

Site Status

Local Institution - 0083

Paris, , France

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Local Institution

Pontoise, , France

Site Status

Local Institution - 0075

Suresnes, , France

Site Status

Local Institution - 0079

Tours, , France

Site Status

Local Institution - 0097

Vandœuvre-lès-Nancy, , France

Site Status

Local Institution - 0096

Villefranche-sur-Saône, , France

Site Status

Local Institution

Bad Berka, , Germany

Site Status

Local Institution - 0073

Berlin, , Germany

Site Status

Local Institution - 0063

Dresden, , Germany

Site Status

Local Institution

Freiburg im Breisgau, , Germany

Site Status

Local Institution - 0102

Gauting, , Germany

Site Status

Local Institution - 0062

Greifenstein, , Germany

Site Status

Local Institution - 0061

Hamburg, , Germany

Site Status

Local Institution - 0113

Hanover, , Germany

Site Status

Local Institution - 0064

Kassel, , Germany

Site Status

Local Institution - 0106

Kiel, , Germany

Site Status

Local Institution - 0065

Leipzig, , Germany

Site Status

Local Institution

Lostau, , Germany

Site Status

Local Institution - 0066

Moers, , Germany

Site Status

Local Institution - 0067

Nuremberg, , Germany

Site Status

Local Institution - 0086

Localita San Filippo Lucca, , Italy

Site Status

Local Institution - 0085

Monza, , Italy

Site Status

Local Institution - 0088

Napoli, , Italy

Site Status

Local Institution - 0087

Roma, , Italy

Site Status

Local Institution - 0069

Barcelona, , Spain

Site Status

Local Institution - 0104

El Palmar, , Spain

Site Status

Local Institution - 0068

Las Palmas de Gran Canaria, , Spain

Site Status

Local Institution - 0070

Seville, , Spain

Site Status

Countries

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United States Australia Austria Canada France Germany Italy Spain

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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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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CA209-384

Identifier Type: -

Identifier Source: org_study_id

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