Clinical trial NCT02741570: Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Official title: An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination With Ipilimumab Versus Extreme Study Regimen (Cetuximab + Cisplatin/Carboplatin + Fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2016-04-18
Enrollment: 947
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 main purpose of this study is to compare nivolumab and ipilimumab with the extreme regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx \& larynx) that is not amenable to curative therapy.
* No prior systemic cancer therapy for recurrent or metastatic disease (except if chemotherapy was part of multimodal treatment completed 6 months prior to enrolment).
* Measurable disease detected by imaging exam (CT or MRI).
* Have tumor tissue for PD L1 expression testing, and for oropharyngeal cancer have results from testing of HPV p16 status.

Exclusion Criteria:

* Metastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma originating from skin and salivary glands or non squamous histologies (eg. mucosal melanoma).
* No prior treatment with anti PD1, anti PD L1, anti CTLA 4 antibody or any other antibody or drugs targeting T cell costimulation or checkpoint pathways, or cetuximab or EGFR inhibitors in any treatment setting.
* Participants with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.
* Inadequate hematologic, renal or hepatic function.

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20
timeFrame: From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)
measure: Overall Survival (OS) in All Randomized Participants
timeFrame: From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)
Secondary outcomes:
measure: Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥ 1
timeFrame: From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months)
measure: Progression Free Survival (PFS)
timeFrame: From randomization to disease progression or death (Up to approximately 65 months)
measure: Objective Response Rate (ORR)
timeFrame: From randomization up to approximately 65 months
measure: Duration of Objective Response (DOR)
timeFrame: From randomization to the first documented response (CR or PR) and progression (up to approximately 65 months)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Local Institution - 0134
state: Arizona
city: Duarte
country: United States
facility: Local Institution - 0135
state: California
city: Stanford
country: United States
facility: Local Institution - 0005
state: California
city: Jacksonville
country: United States
facility: Local Institution - 0028
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0008
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0111
state: Georgia
city: Chicago
country: United States
facility: Local Institution - 0006
state: Illinois
city: Boston
country: United States
facility: Local Institution - 0001
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0080
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0093
state: Massachusetts
city: Ann Arbor
country: United States
facility: Local Institution - 0004
state: Michigan
city: Charlotte
country: United States
facility: Local Institution - 0012
state: North Carolina
city: Columbus
country: United States
facility: Local Institution - 0007
state: Ohio
city: Langhorne
country: United States
facility: Local Institution - 0010
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution - 0015
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0013
state: Pennsylvania
city: Dallas
country: United States
facility: Local Institution - 0139
state: Texas
city: Houston
country: United States
facility: Local Institution - 0009
state: Texas
city: Houston
country: United States
facility: Local Institution - 0014
state: Texas
city: Charlottesville
country: United States
facility: Local Institution - 0003
state: Virginia
city: Fairfax
country: United States
facility: Local Institution - 0011
state: Virginia
city: Morgantown
country: United States
facility: Local Institution - 0125
state: West Virginia
city: Blacktown
country: Australia
facility: Local Institution - 0142
state: New South Wales
city: Darlinghurst
country: Australia
facility: Local Institution - 0127
state: New South Wales
city: Gosford
country: Australia
facility: Local Institution - 0128
state: New South Wales
city: St. Leonards
country: Australia
facility: Local Institution - 0019
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution - 0077
state: Queensland
city: Douglas
country: Australia
facility: Local Institution - 0036
state: Queensland
city: Elizabeth Vale
country: Australia
facility: Local Institution - 0021
state: South Australia
city: Clayton
country: Australia
facility: Local Institution - 0022
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 0131
state: Victoria
city: Nedlands
country: Australia
facility: Local Institution - 0020
state: Western Australia
city: Linz
country: Austria
facility: Local Institution - 0075
city: Wien
country: Austria
facility: Local Institution - 0071
city: Belo Horizonte
country: Brazil
facility: Local Institution - 0148
state: Minas Gerais
city: Ijui
country: Brazil
facility: Local Institution - 0121
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0122
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0120
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Local Institution - 0117
state: Sao Paulo
city: Sao Jose De Rio Preto
country: Brazil
facility: Local Institution - 0123
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution - 0118
city: Sao Paulo
country: Brazil
facility: Local Institution - 0124
city: Amiens
country: France
facility: Local Institution - 0133
state: Somme
city: Bordeaux
country: France
facility: Local Institution - 0094
city: La Tronche
country: France
facility: Local Institution - 0140
city: Lille
country: France
facility: Local Institution - 0090
city: Lyon
country: France
facility: Local Institution - 0138
city: Lyon
country: France
facility: Local Institution - 0054
city: Marseille
country: France
facility: Local Institution - 0126
city: Nice Cedex 2
country: France
facility: Local Institution - 0055
city: Paris
country: France
facility: Local Institution - 0039
city: Paris
country: France
facility: Local Institution - 0088
city: Paris
country: France
facility: Local Institution
city: Strasbourg
country: France
facility: Local Institution - 0089
city: Villejuif Cedex
country: France
facility: Local Institution - 0040
city: Bonn
country: Germany
facility: Local Institution - 0068
city: Freiburg
country: Germany
facility: Local Institution - 0078
city: Hamburg
country: Germany
facility: Local Institution - 0067
city: Hannover
country: Germany
facility: Local Institution - 0092
city: Heidelberg
country: Germany
facility: Local Institution - 0079
city: Leipzig
country: Germany
facility: Local Institution - 0074
city: Mainz
country: Germany
facility: Local Institution - 0070
city: Muenchen
country: Germany
facility: Local Institution - 0065
city: Ulm
country: Germany
facility: Local Institution - 0069
city: Wuerzburg
country: Germany
facility: Local Institution - 0066
city: Athens
country: Greece
facility: Local Institution - 0018
city: Nea Kifissia
country: Greece
facility: Local Institution - 0017
city: Thessaloniki
country: Greece
facility: Local Institution - 0051
city: Dublin 8
country: Ireland
facility: Local Institution - 0147
state: Dublin
city: Haifa
country: Israel
facility: Local Institution - 0062
city: Jerusalem
country: Israel
facility: Local Institution - 0060
city: Petah-tikva
country: Israel
facility: Local Institution - 0063
city: Ramat-gan
country: Israel
facility: Local Institution - 0061
city: Tel-Aviv
country: Israel
facility: Local Institution - 0064
city: Milano
country: Italy
facility: Local Institution - 0042
state: MI
city: Torino
country: Italy
facility: Local Institution - 0043
state: TO
city: Cuneo
country: Italy
facility: Local Institution - 0044
city: Meldola (fc)
country: Italy
facility: IRST Meldola
city: Modena
country: Italy
facility: Azienda Ospedaliera Universitaria Di Modena
city: Napoli
country: Italy
facility: Aorn Dei Colli
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione Pascale
city: Perugia
country: Italy
facility: Azienda Ospedaliera Di Perugia
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli
city: Nagoya
country: Japan
facility: Local Institution - 0106
state: Aichi
city: Kashiwa
country: Japan
facility: Local Institution - 0100
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Local Institution - 0113
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Local Institution - 0105
state: Hokkaido
city: Akashi-shi
country: Japan
facility: Local Institution - 0107
state: Hyogo
city: Kobe-shi
country: Japan
facility: Local Institution - 0102
state: Hyogo
city: Isehara
country: Japan
facility: Local Institution - 0152
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Local Institution - 0150
state: Kanagawa
city: Natori-shi
country: Japan
facility: Local Institution - 0151
state: Miyagi
city: Sendai-shi
country: Japan
facility: Local Institution - 0108
state: Miyagi
city: Osakasayaha
country: Japan
facility: Local Institution - 0146
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Local Institution - 0099
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Local Institution - 0149
state: Saitama
city: Sunto-gun
country: Japan
facility: Local Institution - 0114
state: Shizuoka
city: Shimotsuke-shi
country: Japan
facility: Local Institution
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Local Institution - 0153
state: Tokyo
city: Chuo-ku
country: Japan
facility: Local Institution - 0101
state: Tokyo
city: Koto-ku
country: Japan
facility: Local Institution - 0104
state: Tokyo
city: Kita-gun
country: Japan
facility: Local Institution - 0109
city: Gangnam-gu
country: Korea, Republic of
facility: Local Institution - 0096
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0110
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0095
city: Mexico City
country: Mexico
facility: Local Institution - 0034
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution - 0030
state: Distrito Federal
city: Leon de los Aldama
country: Mexico
facility: Local Institution - 0032
state: Guanajuato
city: Morelia
country: Mexico
facility: Local Institution - 0031
state: Michoacan
city: Monterrey
country: Mexico
facility: Local Institution - 0033
state: Nuevo LEON
city: Oaxaca
country: Mexico
facility: Local Institution - 0035
city: Bydgoszcz
country: Poland
facility: Local Institution - 0037
city: Gdansk
country: Poland
facility: Local Institution - 0023
city: Gliwice
country: Poland
facility: Local Institution - 0129
city: Krakow
country: Poland
facility: Local Institution - 0026
city: Warszawa
country: Poland
facility: Local Institution - 0025
city: Barcelona
country: Spain
facility: Local Institution - 0083
city: L'Hospitalet Del Llobregat
country: Spain
facility: Local Institution - 0130
city: Madrid
country: Spain
facility: Local Institution - 0085
city: Madrid
country: Spain
facility: Local Institution - 0082
city: Sevilla
country: Spain
facility: Local Institution - 0084
city: Valencia
country: Spain
facility: Local Institution - 0081
city: Basel
country: Switzerland
facility: Local Institution - 0072
city: Zuerich
country: Switzerland
facility: Local Institution - 0073
city: Taichung
country: Taiwan
facility: Local Institution - 0097
city: Taipei
country: Taiwan
facility: Local Institution - 0098
city: Newcastle Upon Tyne
country: United Kingdom
facility: Local Institution - 0049
state: Durham
city: London
country: United Kingdom
facility: Local Institution - 0045
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution - 0046
state: Greater Manchester
city: Southampton
country: United Kingdom
facility: Local Institution - 0047
state: Hampshire
city: Sutton
country: United Kingdom
facility: Local Institution - 0091
state: Surrey
city: Birmingham
country: United Kingdom
facility: Local Institution - 0050
state: West Midlands
city: Sheffield
country: United Kingdom
facility: Local Institution - 0132
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Hwang M, Seiwert TY. Are taxanes the future for head and neck cancer? Pragmatism in the immunotherapy era. Lancet Oncol. 2021 Apr;22(4):413-415. doi: 10.1016/S1470-2045(21)00121-2. Epub 2021 Mar 5. No abstract available.