Clinical trial NCT02713867: 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
Official title: A Dose Frequency Optimization, Phase IIIB/IV 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-03-21
Enrollment: 363
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Progression Free Survival Rate (PFSR) at 6 Months
timeFrame: At 6 Months
measure: Progression Free Survival Rate (PFSR) at 12 Months
timeFrame: At 12 Months
Secondary outcomes:
measure: Progression Free Survival Rate (PFSR) at 24 Months
timeFrame: At 24 Months
measure: Progression Free Survival Rate (PFSR) by Tumor Histology at 12 Months
timeFrame: At 12 Months
measure: Progression Free Survival Rate (PFSR) by Response Criteria at 12 Months
timeFrame: At 12 Months
measure: Overall Survival (OS) Rate at 12 Months
timeFrame: At 12 Months
measure: Overall Survival (OS) Rate up to 60 Months
timeFrame: From randomization to the date of death, Up to 60 Months
measure: Overall Survival Rate by Histology at 12 Months
timeFrame: at 12 Months
measure: Overall Survival Rate by Response Criteria at 12 Months
timeFrame: 12 Months
measure: Percentage of Participants With an Adverse Events (AEs)
timeFrame: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
measure: Percentage of Participants With an Serious Adverse Events (SAEs)
timeFrame: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
measure: Percentage of Participants With an Adverse Events Leading to Discontinuation (AEsDC)
timeFrame: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
measure: Percentage of Participants With an Immune Mediated Adverse Events (IMAEs)
timeFrame: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
measure: Percentage of Participants With an Select Adverse Events
timeFrame: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
measure: Percentage of Participants With an Event of Special Interest (ESI)
timeFrame: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
measure: Percentage of Participants Who Experienced Death
timeFrame: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0004
state: Alabama
city: Phoenix
country: United States
facility: Local Institution - 0030
state: Arizona
city: Phoenix
country: United States
facility: Local Institution - 0041
state: Arizona
city: Bakersfield
country: United States
facility: CBCC Global Research, Inc.
state: California
city: Bellflower
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Fullerton
country: United States
facility: St Jude Hospital Yorba Linda
state: California
city: Los Angeles
country: United States
facility: Local Institution - 0046
state: California
city: Orange
country: United States
facility: Local Institution - 0126
state: California
city: Redondo Beach
country: United States
facility: Torrance Health Association
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Santa Barbara
country: United States
facility: Local Institution - 0010
state: California
city: Santa Maria
country: United States
facility: Local Institution - 0044
state: California
city: Vallejo
country: United States
facility: Local Institution - 0130
state: California
city: Denver
country: United States
facility: Local Institution - 0017
state: Colorado
city: Fort Collins
country: United States
facility: Local Institution - 0122
state: Colorado
city: Fort Myers
country: United States
facility: Local Institution - 0038
state: Florida
city: Hollywood
country: United States
facility: Local Institution - 0089
state: Florida
city: Ocala
country: United States
facility: Local Institution - 0026
state: Florida
city: Pensacola
country: United States
facility: Local Institution - 0001
state: Florida
city: Saint Petersburg
country: United States
facility: Local Institution - 0039
state: Florida
city: Athens
country: United States
facility: Local Institution - 0008
state: Georgia
city: Columbus
country: United States
facility: Local Institution - 0142
state: Georgia
city: Marietta
country: United States
facility: Local Institution - 0121
state: Georgia
city: Harvey
country: United States
facility: Ingalls Health System
state: Illinois
city: Niles
country: United States
facility: Local Institution - 0098
state: Illinois
city: Peoria
country: United States
facility: Local Institution - 0100
state: Illinois
city: Urbana
country: United States
facility: Local Institution - 0143
state: Illinois
city: Fort Wayne
country: United States
facility: Local Institution - 0099
state: Indiana
city: Fort Wayne
country: United States
facility: Local Institution - 0050
state: Indiana
city: Indianapolis
country: United States
facility: Innova Schar Cancer Institute
state: Indiana
city: Wichita
country: United States
facility: Local Institution - 0123
state: Kansas
city: Paducah
country: United States
facility: Local Institution - 0112
state: Kentucky
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: New Orleans
country: United States
facility: Local Institution - 0137
state: Louisiana
city: Brewer
country: United States
facility: Local Institution - 0109
state: Maine
city: Bethesda
country: United States
facility: Local Institution - 0042
state: Maryland
city: Springfield
country: United States
facility: Local Institution - 0125
state: Massachusetts
city: Southfield
country: United States
facility: Local Institution - 0136
state: Michigan
city: Minneapolis
country: United States
facility: Local Institution - 0120
state: Minnesota
city: Tupelo
country: United States
facility: Local Institution - 0116
state: Mississippi
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: Omaha
country: United States
facility: Local Institution - 0014
state: Nebraska
city: Lebanon
country: United States
facility: Local Institution - 0141
state: New Hampshire
city: Albany
country: United States
facility: Local Institution - 0035
state: New York
city: Johnson City
country: United States
facility: Local Institution - 0013
state: New York
city: Pinehurst
country: United States
facility: Local Institution - 0127
state: North Carolina
city: Canton
country: United States
facility: Hematology And Oncology Associates
state: Ohio
city: Cincinnati
country: United States
facility: Local Institution - 0037
state: Ohio
city: Cincinnati
country: United States
facility: Local Institution - 0132
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Cancer Care Center
state: Ohio
city: Massillon
country: United States
facility: Local Institution - 0129
state: Ohio
city: Medford
country: United States
facility: Hematology Oncology Consultants, Pc
state: Oregon
city: Pittsburgh
country: United States
facility: Local Institution - 0005
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution - 0020
state: South Carolina
city: Sioux Falls
country: United States
facility: Local Institution - 0124
state: South Dakota
city: Germantown
country: United States
facility: Jones Clinic PC
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 0036
state: Tennessee
city: Abilene
country: United States
facility: Local Institution - 0023
state: Texas
city: Amarillo
country: United States
facility: Texas Oncology - Amarillo
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0011
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0022
state: Texas
city: Denton
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: El Paso
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Flower Mound
country: United States
facility: Local Institution - 0025
state: Texas
city: Houston
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Longview
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Midland
country: United States
facility: Local Institution - 0119
state: Texas
city: Plano
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Sherman
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Sugar Land
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Wichita Falls
country: United States
facility: Local Institution - 0034
state: Texas
city: Falls Church
country: United States
facility: Innova Schar Cancer Institute
state: Virginia
city: Winchester
country: United States
facility: Shenandoah Oncology
state: Virginia
city: Spokane Valley
country: United States
facility: Cancer Care Northwest
state: Washington
city: Vancouver
country: United States
facility: Local Institution - 0031
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital/North Star Lodge
state: Washington
city: St. Leonards
country: Australia
facility: Local Institution - 0052
state: New South Wales
city: Waratah
country: Australia
facility: Local Institution - 0118
state: New South Wales
city: Westmead,
country: Australia
facility: Local Institution - 0117
state: New South Wales
city: Woolloongabba
country: Australia
facility: Local Institution - 0093
state: Queensland
city: Bedford Park
country: Australia
facility: Local Institution - 0054
state: South Australia
city: Elizabeth Vale
country: Australia
facility: Local Institution - 0056
state: South Australia
city: Kurralta Park
country: Australia
facility: Local Institution - 0055
state: South Australia
city: Hobart
country: Australia
facility: Local Institution - 0057
state: Tasmania
city: Heidelberg
country: Australia
facility: Local Institution - 0053
state: Victoria
city: Murdoch
country: Australia
facility: Local Institution - 0058
state: Western Australia
city: Wien
country: Austria
facility: Local Institution
city: Newmarket
country: Canada
facility: Local Institution - 0059
state: Ontario
city: Laval
country: Canada
facility: Local Institution - 0146
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0145
state: Quebec
city: St. Jerome
country: Canada
facility: Local Institution - 0060
state: Quebec
city: Quebec
country: Canada
facility: Local Institution
city: Angers
country: France
facility: Local Institution - 0081
city: Angers
country: France
facility: Local Institution - 0105
city: Bayonne
country: France
facility: Local Institution - 0080
city: Clermont-Ferrand Cedex 01
country: France
facility: Local Institution - 0076
city: Le Mans
country: France
facility: Local Institution - 0077
city: Mulhouse
country: France
facility: Local Institution - 0072
city: Nimes
country: France
facility: Local Institution - 0078
city: Paris
country: France
facility: Local Institution - 0095
city: Paris
country: France
facility: Local Institution - 0083
city: Pontoise
country: France
facility: Local Institution
city: Suresnes Cedex
country: France
facility: Local Institution - 0075
city: Tours
country: France
facility: Local Institution - 0079
city: Vandoeuvre-les-Nancy
country: France
facility: Local Institution - 0097
city: Villefranche-sur-Saone Cedex
country: France
facility: Local Institution - 0096
city: Bad Berka
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution - 0073
city: Dresden
country: Germany
facility: Local Institution - 0063
city: Freiburg
country: Germany
facility: Local Institution
city: Gauting
country: Germany
facility: Local Institution - 0102
city: Greifenstein
country: Germany
facility: Local Institution - 0062
city: Hamburg
country: Germany
facility: Local Institution - 0061
city: Hannover
country: Germany
facility: Local Institution - 0113
city: Kassel
country: Germany
facility: Local Institution - 0064
city: Kiel
country: Germany
facility: Local Institution - 0106
city: Leipzig
country: Germany
facility: Local Institution - 0065
city: Lostau
country: Germany
facility: Local Institution
city: Moers
country: Germany
facility: Local Institution - 0066
city: Nürnberg
country: Germany
facility: Local Institution - 0067
city: Localita San Filippo Lucca
country: Italy
facility: Local Institution - 0086
city: Monza
country: Italy
facility: Local Institution - 0085
city: Napoli
country: Italy
facility: Local Institution - 0088
city: Roma
country: Italy
facility: Local Institution - 0087
city: Barcelona
country: Spain
facility: Local Institution - 0069
city: El Palmar
country: Spain
facility: Local Institution - 0104
city: Las Palmas de Gran Canaria
country: Spain
facility: Local Institution - 0068
city: Sevilla
country: Spain
facility: Local Institution - 0070
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: