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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02741570
Ethics application status
Date submitted
13/04/2016
Date registered
18/04/2016
Date last updated
21/09/2023

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
Experimental: Nivolumab and Ipilimumab - Specified dose on specified days

Active comparator: Extreme Regimen - Specified dose on specified days
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) =20
Timepoint [1] 0 0
From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)
Primary outcome [2] 0 0
Overall Survival (OS) in All Randomized Participants
Timepoint [2] 0 0
From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)
Secondary outcome [1] 0 0
Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) = 1
Timepoint [1] 0 0
From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months)
Secondary outcome [2] 0 0
Progression Free Survival (PFS)
Timepoint [2] 0 0
From randomization to disease progression or death (Up to approximately 65 months)
Secondary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
From randomization up to approximately 65 months
Secondary outcome [4] 0 0
Duration of Objective Response (DOR)
Timepoint [4] 0 0
From randomization to the first documented response (CR or PR) and progression (up to approximately 65 months)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/09/2022
Sample size
Target
Accrual to date
Final
947
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0142 - Blacktown
Recruitment hospital [2] 0 0
Local Institution - 0127 - Darlinghurst
Recruitment hospital [3] 0 0
Local Institution - 0128 - Gosford
Recruitment hospital [4] 0 0
Local Institution - 0019 - St. Leonards
Recruitment hospital [5] 0 0
Local Institution - 0077 - Brisbane
Recruitment hospital [6] 0 0
Local Institution - 0036 - Douglas
Recruitment hospital [7] 0 0
Local Institution - 0021 - Elizabeth Vale
Recruitment hospital [8] 0 0
Local Institution - 0022 - Clayton
Recruitment hospital [9] 0 0
Local Institution - 0131 - Melbourne
Recruitment hospital [10] 0 0
Local Institution - 0020 - Nedlands
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
3000 - Melbourne
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
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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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United States of America
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Illinois
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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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Sao Paulo
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France
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Somme
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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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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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Meldola (fc)
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Modena
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Napoli
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Roma
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Aichi
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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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Japan
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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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Japan
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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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Gangnam-gu
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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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Mexico
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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 Del Llobregat
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Spain
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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
Country [86] 0 0
Switzerland
State/province [86] 0 0
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
State/province [90] 0 0
Durham
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United Kingdom
State/province [91] 0 0
Greater London
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United Kingdom
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Greater Manchester
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United Kingdom
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Hampshire
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United Kingdom
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Surrey
Country [95] 0 0
United Kingdom
State/province [95] 0 0
West Midlands
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Ono Pharmaceutical Co. Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02741570