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

NCT02713867 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: CA209-384
• Study Type: interventional
• Target: 363
• Locations: 7 countries
• Sites: 128

Brief Summary

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).

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival Rate (PFSR) at 6 Months

  The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.

  At 6 Months

• Progression Free Survival Rate (PFSR) at 12 Months

  The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.

  At 12 Months

Secondary Outcomes (15)

• Progression Free Survival Rate (PFSR) at 24 Months

  At 24 Months

• Progression Free Survival Rate (PFSR) by Tumor Histology at 12 Months

  At 12 Months

• Progression Free Survival Rate (PFSR) by Response Criteria at 12 Months

  At 12 Months

• Overall Survival (OS) Rate at 12 Months

  At 12 Months

• Overall Survival (OS) Rate up to 60 Months

  From randomization to the date of death, Up to 60 Months

Study Arms (2)

Nivolumab 240 mg

ACTIVE COMPARATOR

Nivolumab 240 mg Every 2 Weeks

Biological: Nivolumab

Nivolumab 480 mg

EXPERIMENTAL

Nivolumab 480 mg Every 4 Weeks

Biological: Nivolumab

Interventions

Nivolumab BIOLOGICAL

Nivolumab 240 mg; Nivolumab 480 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Carcinomatous meningitis
• Untreated, symptomatic Central nervous system (CNS) metastases
• Symptomatic interstitial lung disease

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (129)

Local Institution - 0004

Birmingham, Alabama, 35205, United States

Location

Local Institution - 0030

Phoenix, Arizona, 85016, United States

Location

Local Institution - 0041

Phoenix, Arizona, 85016, United States

Location

CBCC Global Research, Inc.

Bakersfield, California, 93309, United States

Location

Southern California Permanente Medical Group

Bellflower, California, 90706, United States

Location

St Jude Hospital Yorba Linda

Fullerton, California, 92835, United States

Location

Local Institution - 0046

Los Angeles, California, 90095, United States

Location

Local Institution - 0126

Orange, California, 92868, United States

Location

Torrance Health Association

Redondo Beach, California, 90227, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Local Institution - 0010

Santa Barbara, California, 93015, United States

Location

Local Institution - 0044

Santa Maria, California, 93454, United States

Location

Local Institution - 0130

Vallejo, California, 94589, United States

Location

Local Institution - 0017

Denver, Colorado, 80218-1210, United States

Location

Local Institution - 0122

Fort Collins, Colorado, 80528, United States

Location

Local Institution - 0038

Fort Myers, Florida, 33901, United States

Location

Local Institution - 0089

Hollywood, Florida, 33021, United States

Location

Local Institution - 0026

Ocala, Florida, 34471, United States

Location

Local Institution - 0001

Pensacola, Florida, 32504, United States

Location

Local Institution - 0039

St. Petersburg, Florida, 33705, United States

Location

Local Institution - 0008

Athens, Georgia, 30607, United States

Location

Local Institution - 0142

Columbus, Georgia, 31904, United States

Location

Local Institution - 0121

Marietta, Georgia, 30060, United States

Location

Ingalls Health System

Harvey, Illinois, 60426, United States

Location

Local Institution - 0098

Niles, Illinois, 60714, United States

Location

Local Institution - 0100

Peoria, Illinois, 61615, United States

Location

Local Institution - 0143

Urbana, Illinois, 61801-2594, United States

Location

Local Institution - 0099

Fort Wayne, Indiana, 46485, United States

Location

Local Institution - 0050

Fort Wayne, Indiana, 46804, United States

Location

Innova Schar Cancer Institute

Indianapolis, Indiana, 46237, United States

Location

Local Institution - 0123

Wichita, Kansas, 67214, United States

Location

Local Institution - 0112

Paducah, Kentucky, 42003, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

Local Institution - 0137

New Orleans, Louisiana, 70121, United States

Location

Local Institution - 0109

Brewer, Maine, 04412, United States

Location

Local Institution - 0042

Bethesda, Maryland, 20817, United States

Location

Local Institution - 0125

Springfield, Massachusetts, 01107, United States

Location

Local Institution - 0136

Southfield, Michigan, 48075, United States

Location

Local Institution - 0120

Minneapolis, Minnesota, 55404, United States

Location

Local Institution - 0116

Tupelo, Mississippi, 38801, United States

Location

Mercy Medical Research Institute

Springfield, Missouri, 65806, United States

Location

Local Institution - 0014

Omaha, Nebraska, 68130, United States

Location

Local Institution - 0141

Lebanon, New Hampshire, 03756, United States

Location

Local Institution - 0035

Albany, New York, 12206, United States

Location

Local Institution - 0013

Johnson City, New York, 13790, United States

Location

Local Institution - 0127

Pinehurst, North Carolina, 28374, United States

Location

Hematology And Oncology Associates

Canton, Ohio, 44708, United States

Location

Local Institution - 0037

Cincinnati, Ohio, 45242, United States

Location

Local Institution - 0132

Cincinnati, Ohio, 45242, United States

Location

MetroHealth Cancer Care Center

Cleveland, Ohio, 44109, United States

Location

Local Institution - 0129

Massillon, Ohio, 44646, United States

Location

Hematology Oncology Consultants, Pc

Medford, Oregon, 97504, United States

Location

Local Institution - 0005

Pittsburgh, Pennsylvania, 15224, United States

Location

Local Institution - 0020

Charleston, South Carolina, 29414, United States

Location

Local Institution - 0124

Sioux Falls, South Dakota, 57105, United States

Location

Jones Clinic PC

Germantown, Tennessee, 38138, United States

Location

Local Institution - 0036

Nashville, Tennessee, 37203, United States

Location

Local Institution - 0023

Abilene, Texas, 79606-5208, United States

Location

Texas Oncology - Amarillo

Amarillo, Texas, 79106, United States

Location

Local Institution - 0011

Dallas, Texas, 75230, United States

Location

Local Institution - 0022

Dallas, Texas, 75231, United States

Location

Texas Oncology, P.A.

Denton, Texas, 76210, United States

Location

Texas Oncology, P.A.

El Paso, Texas, 79902, United States

Location

Local Institution - 0025

Flower Mound, Texas, 75028, United States

Location

Texas Oncology, P.A.

Houston, Texas, 77024, United States

Location

Texas Oncology, P.A.

Longview, Texas, 75601, United States

Location

Local Institution - 0119

Midland, Texas, 79701, United States

Location

Texas Oncology, P.A.

Plano, Texas, 75093, United States

Location

Texas Oncology, P.A.

San Antonio, Texas, 78212, United States

Location

Texas Oncology, P.A.

Sherman, Texas, 75090, United States

Location

Texas Oncology, P.A.

Sugar Land, Texas, 77479, United States

Location

Local Institution - 0034

Wichita Falls, Texas, 76310, United States

Location

Innova Schar Cancer Institute

Falls Church, Virginia, 22042, United States

Location

Shenandoah Oncology

Winchester, Virginia, 22601, United States

Location

Cancer Care Northwest

Spokane Valley, Washington, 99216, United States

Location

Local Institution - 0031

Vancouver, Washington, 98684, United States

Location

Yakima Valley Memorial Hospital/North Star Lodge

Yakima, Washington, 98902, United States

Location

Local Institution - 0052

St Leonards, New South Wales, 2065, Australia

Location

Local Institution - 0118

Waratah, New South Wales, 2298, Australia

Location

Local Institution - 0117

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 0093

Woolloongabba, Queensland, 4102, Australia

Location

Local Institution - 0054

Bedford Park, South Australia, 5042, Australia

Location

Local Institution - 0056

Elizabeth Vale, South Australia, 5112, Australia

Location

Local Institution - 0055

Kurralta Park, South Australia, 5037, Australia

Location

Local Institution - 0057

Hobart, Tasmania, 7000, Australia

Location

Local Institution - 0053

Heidelberg, Victoria, 3084, Australia

Location

Local Institution - 0058

Murdoch, Western Australia, 6150, Australia

Location

Local Institution

Vienna, 1090, Austria

Location

Local Institution - 0059

Newmarket, Ontario, L3Y 2P9, Canada

Location

Local Institution - 0146

Laval, Quebec, H7M 3L9, Canada

Location

Local Institution - 0145

Montreal, Quebec, H4J 1C5, Canada

Location

Local Institution

Québec, Quebec, GIJ 1Z4, Canada

Location

Local Institution - 0060

Saint-Jérôme, Quebec, J7Z 5T3, Canada

Location

Local Institution - 0081

Angers, 49000, France

Location

Local Institution - 0105

Angers, 49000, France

Location

Local Institution - 0080

Bayonne, 64109, France

Location

Local Institution - 0076

Clermont-Ferrand, 63003, France

Location

Local Institution - 0077

Le Mans, 72000, France

Location

Local Institution - 0072

Mulhouse, 68100, France

Location

Local Institution - 0078

Nîmes, 30029, France

Location

Local Institution - 0095

Paris, 75005, France

Location

Local Institution - 0083

Paris, 75014, France

Location

Local Institution

Pontoise, 95300, France

Location

Local Institution - 0075

Suresnes, 92 151, France

Location

Local Institution - 0079

Tours, 37044, France

Location

Local Institution - 0097

Vandœuvre-lès-Nancy, 54519, France

Location

Local Institution - 0096

Villefranche-sur-Saône, 69655, France

Location

Local Institution

Bad Berka, 99437, Germany

Location

Local Institution - 0073

Berlin, 13353, Germany

Location

Local Institution - 0063

Dresden, 01307, Germany

Location

Local Institution

Freiburg im Breisgau, 79106, Germany

Location

Local Institution - 0102

Gauting, 82131, Germany

Location

Local Institution - 0062

Greifenstein, 35753, Germany

Location

Local Institution - 0061

Hamburg, 20251, Germany

Location

Local Institution - 0113

Hanover, 30625, Germany

Location

Local Institution - 0064

Kassel, 34125, Germany

Location

Local Institution - 0106

Kiel, 24105, Germany

Location

Local Institution - 0065

Leipzig, 04357, Germany

Location

Local Institution

Lostau, 39291, Germany

Location

Local Institution - 0066

Moers, 47447, Germany

Location

Local Institution - 0067

Nuremberg, 90419, Germany

Location

Local Institution - 0086

Localita San Filippo Lucca, 55100, Italy

Location

Local Institution - 0085

Monza, 20900, Italy

Location

Local Institution - 0088

Napoli, 80131, Italy

Location

Local Institution - 0087

Roma, 00128, Italy

Location

Local Institution - 0069

Barcelona, 08208, Spain

Location

Local Institution - 0104

El Palmar, 30120, Spain

Location

Local Institution - 0068

Las Palmas de Gran Canaria, 35016, Spain

Location

Local Institution - 0070

Seville, 41013, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

No formal statistical analyses were conducted. Median OS was not reached in either arm.

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 21, 2016
• Study Start: May 24, 2016
• Primary Completion: July 15, 2019
• Study Completion: January 18, 2022
• Last Updated: February 14, 2023
• Results First Posted: June 22, 2020

Record last verified: 2023-01

Locations

CA (5); AU (10); DE (14); ES (4); US (77); IT (4); FR (14)