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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02741570




Registration number
NCT02741570
Ethics application status
Date submitted
13/04/2016
Date registered
18/04/2016
Date last updated
24/04/2020

Titles & IDs
Public title
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
Scientific 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)
Secondary ID [1] 0 0
2016-000725-39
Secondary ID [2] 0 0
CA209-651
Universal Trial Number (UTN)
Trial acronym
CheckMate 651
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Nivolumab
Other interventions - Ipilimumab
Treatment: Drugs - Cetuximab/Erbitux
Treatment: Drugs - Cisplatin/Platinol
Treatment: Drugs - Carboplatin/Paraplatin
Treatment: Drugs - Fluorouracil/Adrucil

Experimental: Nivolumab and Ipilimumab - Specified dose on specified days

Active Comparator: Extreme Regimen - Specified dose on specified days


Other interventions: Nivolumab


Other interventions: Ipilimumab


Treatment: Drugs: Cetuximab/Erbitux


Treatment: Drugs: Cisplatin/Platinol


Treatment: Drugs: Carboplatin/Paraplatin


Treatment: Drugs: Fluorouracil/Adrucil


Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) in participants with PD-L1 expressing tumors.
Timepoint [1] 0 0
Approximately 51 months
Primary outcome [2] 0 0
Overall Survival (OS) in all participants.
Timepoint [2] 0 0
Approxmiately 51 months
Secondary outcome [1] 0 0
OS (overall survival) in participants with PD-LI expressing tumors with different cut off value
Timepoint [1] 0 0
Approximately 51 months
Secondary outcome [2] 0 0
ORR (objective response rate) in all participants and those with PD-L1 expressing tumors
Timepoint [2] 0 0
Approximately 51 months
Secondary outcome [3] 0 0
Duration of Response (DOR) in all participants and those with PD-L1 expressing tumors
Timepoint [3] 0 0
Approximately 51 months
Secondary outcome [4] 0 0
PFS (Progression Free Survival) in all participants and those with PD-L1 expressing tumors
Timepoint [4] 0 0
Approxmiately 51 months

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



- 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
St Vincent'S Hospital (Nsw) - Darlinghurst
Recruitment hospital [3] 0 0
Local Institution - Gosford
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [5] 0 0
Local Institution - Brisbane
Recruitment hospital [6] 0 0
Local Institution - Douglas
Recruitment hospital [7] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [8] 0 0
Monash Medical Centre Clayton - Clayton
Recruitment hospital [9] 0 0
Local Institution - Nedlands
Recruitment hospital [10] 0 0
Local Institution - Melbourne
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2065 - St. Leonards
Recruitment postcode(s) [5] 0 0
4102 - Brisbane
Recruitment postcode(s) [6] 0 0
4814 - Douglas
Recruitment postcode(s) [7] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment postcode(s) [10] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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Florida
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Georgia
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Illinois
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United States of America
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Massachusetts
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Michigan
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North Carolina
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Ohio
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Pennsylvania
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Texas
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Virginia
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United States of America
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West Virginia
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Austria
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Linz
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Austria
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Wien
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Brazil
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Minas Gerais
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Brazil
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RIO Grande DO SUL
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Brazil
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RS
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Brazil
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SAO Paulo
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Brazil
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Sao Paulo
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France
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Amiens
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France
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Bordeaux
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France
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La Tronche
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France
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Lille
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France
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Lyon
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France
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Marseille
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France
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Nice Cedex 2
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France
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Paris
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France
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Strasbourg
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France
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Villejuif Cedex
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Germany
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Bonn
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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Muenchen
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Germany
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Ulm
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Germany
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Wuerzburg
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Greece
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Athens
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Greece
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Nea Kifissia
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Greece
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Thessaloniki
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Ireland
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Dublin
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah-tikva
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Israel
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Ramat-gan
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Israel
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Tel-Aviv
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Italy
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FC
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Italy
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MI
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Italy
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TO
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Italy
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Cuneo
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Italy
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Modena
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Italy
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Napoli
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Italy
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Perugia
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Italy
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Roma
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Japan
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Aichi
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Japan
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Chiba
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Fukuoka
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Hokkaido
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Hyogo
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Kanagawa
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Miyagi
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Osaka
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Japan
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Saitama
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Japan
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Shizuoka
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Tochigi
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Tokyo
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Japan
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Kita-gun
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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Mexico
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Guanajuato
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Mexico
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Michoacan
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Nuevo LEON
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Mexico
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Oaxaca
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Poland
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Bydgoszcz
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Gdansk
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Gliwice
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Krakow
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Warszawa
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Spain
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Barcelona
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Spain
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L?Hospitalet De Llobregat
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Switzerland
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Basel
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Switzerland
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Zuerich
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Taiwan
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Taichung
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Taiwan
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Taipei
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United Kingdom
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Durham
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United Kingdom
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Greater London
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United Kingdom
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Hampshire
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United Kingdom
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Surrey
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United Kingdom
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WEST Midlands
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Manchester
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United Kingdom
State/province [97] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT02741570
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications