Clinical trial NCT02869789: An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers
Official title: A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-08-17
Enrollment: 1041
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed Stage 4 or recurrent non-small cell lung cancer
* Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer)
* No prior systemic anticancer therapy (including EGFR and ALK inhibitors)
* Tissue or Programmed death-ligand 1 (PD-L1) results available

Cohort 1A Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) score 2 or
* Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol

Cohort C Inclusion Criteria:

* High Tumor Mutation Burden

Exclusion Criteria:

* Untreated brain metastases
* An active malignancy that requires concurrent intervention
* Active, known or suspected autoimmune disease
* Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs)
timeFrame: From first dose to 30 days post last dose (Up to approximately 27 months)
measure: Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs)
timeFrame: From first dose to 100 days post last dose (Up to approximately 29 months)
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From first dosing date to the date of first documented tumor progression or, death due to any cause, whichever occurs first (Up to approximately 67 months)
measure: Overall Survival (OS)
timeFrame: From first dosing date to the date of death (Up to approximately 67 months)
measure: Objective Response Rate (ORR)
timeFrame: From first dosing date up to approximately 67 months
measure: Duration of Response (DoR)
timeFrame: From first dosing date to the date of first documented tumor progression or, death due to any cause, whichever occurs first (Up to approximately 67 months)
measure: Change From Baseline in Health-Related Quality of Life (HRQoL) Using Functional Assessment of Cancer Therapy-Lung (FACT-L)
timeFrame: From baseline and up to subsequent survival follow-up visit 18 (Up to approximately 67 months)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0121
state: Alabama
city: Phoenix
country: United States
facility: Local Institution - 0148
state: Arizona
city: Tucson
country: United States
facility: Local Institution - 0085
state: Arizona
city: Little Rock
country: United States
facility: Local Institution - 0164
state: Arkansas
city: Bakersfield
country: United States
facility: Local Institution - 0146
state: California
city: Greenbrae
country: United States
facility: Marin Cancer Care, Inc
state: California
city: Los Angeles
country: United States
facility: Los Angeles Hematology/Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: Local Institution - 0115
state: California
city: Redondo Beach
country: United States
facility: Torrance Health Association
state: California
city: San Diego
country: United States
facility: Va San Diego Healthcare System
state: California
city: San Luis Obispo
country: United States
facility: Local Institution - 0143
state: California
city: Santa Maria
country: United States
facility: Local Institution - 0144
state: California
city: Truckee
country: United States
facility: Gene Upshaw Memorial Tahoe Forest Cancer Center
state: California
city: Whittier
country: United States
facility: Local Institution - 0161
state: California
city: Denver
country: United States
facility: Local Institution - 0083
state: Colorado
city: Grand Junction
country: United States
facility: Local Institution - 0141
state: Colorado
city: Jacksonville
country: United States
facility: Cancer Specialists of North FL
state: Florida
city: Ocala
country: United States
facility: Local Institution - 0082
state: Florida
city: Pembroke Pines
country: United States
facility: Local Institution - 0147
state: Florida
city: Athens
country: United States
facility: Local Institution - 0163
state: Georgia
city: Atlanta
country: United States
facility: Local Institution - 0002
state: Georgia
city: Atlanta
country: United States
facility: Local Institution - 0166
state: Georgia
city: Niles
country: United States
facility: Local Institution - 0088
state: Illinois
city: Wichita
country: United States
facility: Local Institution - 0108
state: Kansas
city: Lexington
country: United States
facility: Kentucky One Health St. Joseph East Cancer Center
state: Kentucky
city: Columbia
country: United States
facility: Local Institution - 0091
state: Maryland
city: Edina
country: United States
facility: Local Institution - 0089
state: Minnesota
city: Jackson
country: United States
facility: Jackson Oncology Associates, Pllc
state: Mississippi
city: Grand Island
country: United States
facility: Local Institution - 0077
state: Nebraska
city: Las Vegas
country: United States
facility: Local Institution - 0087
state: Nevada
city: Reno
country: United States
facility: Local Institution - 0170
state: Nevada
city: Belleville
country: United States
facility: Local Institution - 0156
state: New Jersey
city: Florham Park
country: United States
facility: Summit Medical Group
state: New Jersey
city: Livingston
country: United States
facility: Local Institution - 0142
state: New Jersey
city: Bronx
country: United States
facility: Local Institution - 0167
state: New York
city: Durham
country: United States
facility: Local Institution - 0004
state: North Carolina
city: Winston-Salem
country: United States
facility: Local Institution - 0012
state: North Carolina
city: Cincinnati
country: United States
facility: Local Institution - 0100
state: Ohio
city: Cleveland
country: United States
facility: Local Institution - 0134
state: Ohio
city: Corvallis
country: United States
facility: Local Institution - 0172
state: Oregon
city: Eugene
country: United States
facility: Local Institution - 0096
state: Oregon
city: Portland
country: United States
facility: Local Institution - 0176
state: Oregon
city: Allentown
country: United States
facility: Local Institution - 0139
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0159
state: Pennsylvania
city: Sayre
country: United States
facility: Local Institution - 0001
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution - 0123
state: South Carolina
city: Chattanooga
country: United States
facility: Local Institution - 0066
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 0067
state: Tennessee
city: Austin
country: United States
facility: Local Institution - 0090
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0149
state: Texas
city: Fort Worth
country: United States
facility: Local Institution - 0094
state: Texas
city: Longview
country: United States
facility: Local Institution - 0093
state: Texas
city: Plano
country: United States
facility: Local Institution - 0098
state: Texas
city: Waco
country: United States
facility: Local Institution - 0086
state: Texas
city: Fairfax
country: United States
facility: Local Institution - 0097
state: Virginia
city: Richmond
country: United States
facility: Local Institution - 0044
state: Virginia
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
city: Renton
country: United States
facility: Local Institution - 0174
state: Washington
city: Spokane
country: United States
facility: Local Institution - 0173
state: Washington
city: Capital Federal
country: Argentina
facility: Local Institution - 0008
state: Buenos Aires
city: Viedma
country: Argentina
facility: Local Institution - 0006
state: RIO Negro
city: Caba
country: Argentina
facility: Local Institution - 0007
city: Cordoba
country: Argentina
facility: Local Institution - 0009
city: Tucuman
country: Argentina
facility: Local Institution - 0126
city: Gent
country: Belgium
facility: Local Institution - 0038
city: Liege
country: Belgium
facility: Local Institution - 0037
city: Sint-Niklaas
country: Belgium
facility: Local Institution - 0036
city: Ijui
country: Brazil
facility: Local Institution - 0152
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0154
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0153
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Local Institution - 0151
state: Sao Paulo
city: Greenfield Park
country: Canada
facility: Local Institution - 0127
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0109
state: Quebec
city: Rimouski
country: Canada
facility: Local Institution - 0049
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Local Institution - 0050
state: Quebec
city: Santiago
country: Chile
facility: Local Institution - 0010
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0011
city: Novy Jicin
country: Czechia
facility: Local Institution - 0133
city: Praha 2
country: Czechia
facility: Local Institution - 0130
city: Bordeaux
country: France
facility: Local Institution - 0118
city: Dijon Cedex
country: France
facility: Local Institution - 0075
city: Marseille Cedex 20
country: France
facility: Local Institution - 0069
city: Paris
country: France
facility: Local Institution - 0076
city: Pessac cedex
country: France
facility: Local Institution - 0074
city: Rennes Cedex 9
country: France
facility: Local Institution - 0071
city: Saint Herblain
country: France
facility: Local Institution - 0070
city: Strasbourg Cedex
country: France
facility: Local Institution - 0072
city: Toulon Cedex
country: France
facility: Local Institution - 0073
city: Frankfurt
country: Germany
facility: Local Institution - 0023
city: Gera
country: Germany
facility: Local Institution - 0028
city: Kassel
country: Germany
facility: Local Institution - 0029
city: Loewenstein
country: Germany
facility: Local Institution - 0026
city: Wiesbaden
country: Germany
facility: Local Institution - 0025
city: Athens
country: Greece
facility: Local Institution - 0030
city: N. Faliro
country: Greece
facility: Local Institution - 0031
city: Thessaloniki
country: Greece
facility: Local Institution - 0032
city: Gyöngyös - Mátraháza
country: Hungary
facility: Local Institution - 0013
state: Heves
city: Budapest
country: Hungary
facility: Local Institution - 0014
city: Milan
country: Italy
facility: Local Institution - 0054
state: Lombardia
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Meldola
country: Italy
facility: IRST Meldola
city: Napoli
country: Italy
facility: AOU della Campania Luigi Vanvitelli
city: Napoli
country: Italy
facility: Local Institution
city: Rimini
country: Italy
facility: Ospedale Degli Infermi
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria Terni
city: Monterrey, NL
country: Mexico
facility: Local Institution - 0019
city: Groningen
country: Netherlands
facility: Local Institution - 0045
city: Rotterdam
country: Netherlands
facility: Local Institution - 0035
city: Bydgoszcz
country: Poland
facility: Local Institution - 0015
city: Sucha Beskidzka
country: Poland
facility: Local Institution - 0068
city: Warszawa
country: Poland
facility: Local Institution - 0016
city: Bucuresti
country: Romania
facility: Local Institution - 0128
city: Craiova
country: Romania
facility: Local Institution - 0119
city: Romania
country: Romania
facility: Local Institution - 0120
city: Moscow
country: Russian Federation
facility: Local Institution - 0022
city: Moscow
country: Russian Federation
facility: Local Institution - 0021
city: St Petersburg
country: Russian Federation
facility: Local Institution - 0020
city: A Coruña
country: Spain
facility: Local Institution - 0061
city: Barcelona
country: Spain
facility: Local Institution - 0060
city: Jaen
country: Spain
facility: Local Institution - 0062
city: Madrid
country: Spain
facility: Local Institution - 0065
city: Majadahonda - Madrid
country: Spain
facility: Local Institution - 0064
city: Sevilla
country: Spain
facility: Local Institution - 0063
city: Valencia
country: Spain
facility: Local Institution - 0059
city: Zaragoza
country: Spain
facility: Local Institution - 0112
city: Basel
country: Switzerland
facility: Local Institution - 0048
city: Zuerich
country: Switzerland
facility: Local Institution - 0046
city: Antalya
country: Turkey
facility: Local Institution - 0104
city: London
country: United Kingdom
facility: Local Institution - 0041
state: Greater London
city: Leicester
country: United Kingdom
facility: Local Institution - 0039
state: Leicestershire
city: Edinburgh
country: United Kingdom
facility: Local Institution - 0040
state: Midlothian
city: Newcastle Upon Tyne
country: United Kingdom
facility: Local Institution - 0043
city: Wirral
country: United Kingdom
facility: Local Institution - 0042
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: