Clinical trial NCT02823574: Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Official title: A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-07-06
Enrollment: 425
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: A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)


Eligibility criteria: Inclusion Criteria:

* Confirmed squamous cell head and neck cancer
* Widespread (metastatic) disease, or returned after previous treatment (recurrent)
* Tumor sample must be available for analysis of PDL1 (Programmed death-ligand 1) and HPV \[Human Papilloma Virus (oropharynx only)\]
* Performance status ECOG 0-1 (Eastern Cooperative Oncology Group)

Exclusion Criteria:

* Previous treatment for metastatic or recurrent disease
* Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx, salivary gland, skin
* Any non-squamous subtype
* Active autoimmune disease
* Positive test for hepatitis B, C or HIV (Human Immunodeficiency Virus) virus
* Previous treatment with checkpoint inhibitor drugs
* Active CNS metastases or carcinomatous meningitis

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup
timeFrame: Approximately up to 30 months (from FPFV to Data base lock)
measure: Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup
timeFrame: Approximately up to 30 months (from FPFV to Data base lock)
measure: Time to Response (TTR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup
timeFrame: Approximately up to 30 months (from FPFV to Data base lock)
Secondary outcomes:
measure: Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup
timeFrame: From randomization to end of study. Approximately 63 Months
measure: Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup
timeFrame: From randomization to disease progression or death. Approximately 63 Months
measure: Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup
timeFrame: From randomization to disease progression or death. Approximately 63 Months
measure: Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup
timeFrame: From randomization to disease progression or death. Approximately 63 Months
measure: Overall Survival (OS)
timeFrame: From randomization to death. Approximately 63 Months
measure: Overall Survival (OS) - Platinum Refractory Subgroup
timeFrame: From randomization to death. Approximately 63 Months
measure: Overall Survival (OS) - Platinum Eligible Subgroup
timeFrame: From randomization to death. Approximately 63 Months
measure: ORR - Platinum Eligible Subgroup Based on HPV p-16 Status
timeFrame: From randomization to end of study. Approximately 63 Months
measure: ORR - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Biomarker
timeFrame: From randomization to end of study. Approximately 63 Months
measure: ORR - Platinum Refractory Subgroup Based on HPV p-16 Status
timeFrame: From randomization to end of study. Approximately 63 Months
measure: ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker
timeFrame: From randomization to end of study. Approximately 63 Months
measure: Duration of Response (DOR) - Platinum Refractory Subgroup Based on HPV p-16 Status
timeFrame: From randomization to disease progression or death. Approximately 63 Months
measure: Duration of Response (DOR) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status
timeFrame: From randomization to disease progression or death. Approximately 63 Months
measure: Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on HPV p-16 Status
timeFrame: From randomization to disease progression or death. Approximately 63 Months
measure: Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status
timeFrame: From randomization to disease progression or death. Approximately 63 Months
measure: Overall Survival (OS) - Platinum Refractory Subgroup Based on HPV p-16 Status
timeFrame: From randomization to death. Approximately 63 Months
measure: Overall Survival (OS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status
timeFrame: From randomization to death. Approximately 63 Months
measure: Overall Survival (OS) - Platinum Eligible Subgroup Based on HPV p-16 Status
timeFrame: From randomization to death. Approximately 63 Months
measure: Overall Survival (OS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status
timeFrame: From randomization to death. Approximately 63 Months
measure: Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status
timeFrame: From randomization to disease progression or death. Approximately 63 Months
measure: Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on HPV p-16 Status
timeFrame: From randomization to disease progression or death. Approximately 63 Months
measure: Duration of Response (DOR) - Platinum Eligible Subgroup Based on HPV p-16 Status
timeFrame: From randomization to disease progression or death. Approximately 63 Months
measure: Duration of Response (DOR) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status
timeFrame: From randomization to disease progression or death. Approximately 63 Months
measure: Duration of Response (DOR) - Platinum Refractory Subgroup Based on PD-L1 Status
timeFrame: From randomization to disease progression or death. Approximately 63 Months
measure: ORR - Platinum Refractory Subgroup Based on PD-L1 Expression
timeFrame: From randomization to end of study. Approximately 63 Months
measure: Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status
timeFrame: From randomization to death. Approximately 63 Months
measure: Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status
timeFrame: From randomization to disease progression or death. Approximately 63 Months
measure: Duration of Response (DOR) - Platinum Eligible Subgroup Based on PD-L1 Status
timeFrame: From randomization to disease progression or death. Approximately 63 Months
measure: ORR - Platinum Eligible Subgroup Based on PD-L1 Expression
timeFrame: From randomization to end of study. Approximately 63 Months
measure: Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status
timeFrame: From randomization to death. Approximately 63 Months
measure: Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status
timeFrame: From randomization to disease progression or death. Approximately 63 Months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Duarte
country: United States
facility: Local Institution - 0034
state: California
city: Los Angeles
country: United States
facility: Los Angeles Cancer Network
state: California
city: Los Angeles
country: United States
facility: Ucla Department Of Medicine
state: California
city: Redondo Beach
country: United States
facility: Local Institution - 0098
state: California
city: Sacramento
country: United States
facility: Local Institution - 0004
state: California
city: San Francisco
country: United States
facility: Local Institution - 0072
state: California
city: San Luis Obispo
country: United States
facility: Local Institution - 0097
state: California
city: Santa Maria
country: United States
facility: Central Coast Med Oncology
state: California
city: New Haven
country: United States
facility: Local Institution - 0101
state: Connecticut
city: Tampa
country: United States
facility: Local Institution - 0007
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0010
state: Georgia
city: Decatur
country: United States
facility: Local Institution - 0015
state: Georgia
city: Chicago
country: United States
facility: Local Institution - 0087
state: Illinois
city: Fort Wayne
country: United States
facility: Ft. Wayne Med Onco-Hema Inc
state: Indiana
city: Louisville
country: United States
facility: Local Institution - 0005
state: Kentucky
city: Paducah
country: United States
facility: Oncology Associated Of Western Kentucky
state: Kentucky
city: Boston
country: United States
facility: Local Institution - 0001
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0071
state: Massachusetts
city: Rochester
country: United States
facility: Local Institution - 0042
state: Minnesota
city: Asheville
country: United States
facility: Mission Hospital, Inc
state: North Carolina
city: Cincinnati
country: United States
facility: Local Institution - 0103
state: Ohio
city: Cleveland
country: United States
facility: Local Institution - 0070
state: Ohio
city: Portland
country: United States
facility: Local Institution - 0008
state: Oregon
city: Pittsburgh
country: United States
facility: Local Institution - 0006
state: Pennsylvania
city: Sayre
country: United States
facility: Donald Guthrie Foundation
state: Pennsylvania
city: Dallas
country: United States
facility: Local Institution - 0102
state: Texas
city: Seattle
country: United States
facility: Local Institution - 0038
state: Washington
city: Pergamino
country: Argentina
facility: Local Institution - 0121
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution - 0111
city: Gent
country: Belgium
facility: Local Institution - 0023
city: Sint-Niklaas
country: Belgium
facility: Local Institution - 0074
city: Yvoir
country: Belgium
facility: Local Institution - 0053
city: Belo Horizonte
country: Brazil
facility: Local Institution - 0046
state: Minas Gerais
city: Ipatinga
country: Brazil
facility: Local Institution - 0124
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Local Institution - 0047
state: Parana
city: Caxias do Sul
country: Brazil
facility: Local Institution - 0125
state: RIO Grande DO SUL
city: Ijui
country: Brazil
facility: Local Institution - 0051
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0052
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Local Institution - 0045
state: Sao Paulo
city: Santo Andre
country: Brazil
facility: Local Institution - 0123
state: Sao Paulo
city: Sao Jose do Rio Preto
country: Brazil
facility: Local Institution - 0048
state: SAO Paulo
city: Rio de Janeiro
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution - 0049
city: Sao Paulo
country: Brazil
facility: Local Institution - 0050
city: Edmonton
country: Canada
facility: Local Institution - 0013
state: Alberta
city: Ottawa
country: Canada
facility: Local Institution - 0056
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0012
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0016
state: Quebec
city: Quebec
country: Canada
facility: Local Institution - 0014
city: Santiago
country: Chile
facility: Local Institution - 0115
state: Metropolitana
city: Brno
country: Czechia
facility: Local Institution - 0022
city: Hradec Kralove
country: Czechia
facility: Local Institution - 0020
city: Olomouc
country: Czechia
facility: Local Institution - 0021
city: Helsinki
country: Finland
facility: Local Institution - 0069
city: Amiens Cedex 1
country: France
facility: Local Institution - 0032
city: Bordeaux
country: France
facility: Local Institution - 0120
city: Clermont Ferrand cedex 01
country: France
facility: Local Institution - 0073
city: Clichy
country: France
facility: Local Institution - 0089
city: Lyon Cedex 08
country: France
facility: Local Institution - 0029
city: Marseille Cedex 5
country: France
facility: Local Institution - 0075
city: Nice
country: France
facility: Local Institution - 0079
city: Rennes Cedex
country: France
facility: Local Institution - 0030
city: Villejuif
country: France
facility: Local Institution - 0088
city: Dublin 8
country: Ireland
facility: Local Institution - 0026
state: Dublin
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution - 0119
city: Merida
country: Mexico
facility: Local Institution - 0090
state: Yucatan
city: Merida
country: Mexico
facility: Local Institution - 0107
state: Yucatan
city: Oaxaca
country: Mexico
facility: Local Institution - 0108
city: Amsterdam
country: Netherlands
facility: Local Institution - 0068
city: Amsterdam
country: Netherlands
facility: Local Institution - 0028
city: Groningen
country: Netherlands
facility: Local Institution - 0027
city: Bergen
country: Norway
facility: Local Institution - 0065
city: Oslo
country: Norway
facility: Local Institution - 0064
city: Bucharest
country: Romania
facility: Local Institution - 0055
city: Cluj-Napoca
country: Romania
facility: Local Institution - 0054
city: Craiova
country: Romania
facility: Local Institution - 0033
city: Iasi
country: Romania
facility: Local Institution - 0060
city: Suceava
country: Romania
facility: Local Institution - 0059
city: Moscow
country: Russian Federation
facility: Local Institution - 0031
city: Ryazan
country: Russian Federation
facility: Local Institution - 0092
city: Port Elizabeth
country: South Africa
facility: Local Institution
state: Eastern Cape
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Sandton
country: South Africa
facility: Local Institution - 0017
state: Gauteng
city: Cape Town
country: South Africa
facility: Local Institution
state: Western CAPE
city: A Coruna
country: Spain
facility: Local Institution - 0040
city: Barcelona
country: Spain
facility: Local Institution - 0116
city: Barcelona
country: Spain
facility: Local Institution - 0039
city: Madrid
country: Spain
facility: Local Institution - 0077
city: Marbella
country: Spain
facility: Local Institution - 0076
city: San Sabastian Gipuzkoa
country: Spain
facility: Local Institution - 0041
city: Goteborg
country: Sweden
facility: Local Institution - 0067
city: Lund
country: Sweden
facility: Local Institution - 0037
city: Stockholm
country: Sweden
facility: Local Institution - 0035
city: Adana
country: Turkey
facility: Local Institution - 0063
city: Antalya
country: Turkey
facility: Local Institution - 0066
city: Izmir
country: Turkey
facility: Local Institution - 0062
city: Aberdeen
country: United Kingdom
facility: Local Institution - 0110
state: Aberdeenshire
city: London
country: United Kingdom
facility: Local Institution - 0086
state: Greater London
city: Wirral
country: United Kingdom
facility: Local Institution - 0083
state: Merseyside
city: Sutton
country: United Kingdom
facility: Local Institution - 0081
state: Surrey
city: Cardiff
country: United Kingdom
facility: Local Institution - 0114
city: Glasgow
country: United Kingdom
facility: Local Institution - 0084
city: Newcastle Upon Tyne
country: United Kingdom
facility: Local Institution - 0082
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: