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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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)
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Secondary ID [1]
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2016-000725-39
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Secondary ID [2]
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CA209-651
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 651
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer
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0
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Condition category
Condition code
Cancer
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0
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Non melanoma skin cancer
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Cancer
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0
0
0
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Head and neck
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) =20
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Assessment method [1]
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Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)
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Timepoint [1]
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From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)
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Primary outcome [2]
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Overall Survival (OS) in All Randomized Participants
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Assessment method [2]
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Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)
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Timepoint [2]
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From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)
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Secondary outcome [1]
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Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) = 1
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Assessment method [1]
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Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)
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Timepoint [1]
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From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months)
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Secondary outcome [2]
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Progression Free Survival (PFS)
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Assessment method [2]
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PFS is defined as the time between the date of randomization and the date of first documented tumor progression, based on Blinded Independent Central Review (BICR) assessments (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria), or death due to any cause, whichever occurs first. Participants who neither progress nor die will be censored on the date of their last tumor assessment. Participants who receive subsequent anti-cancer therapy prior to documented progression, will be censored on the date of their last tumor assessment prior to subsequent therapy. (Based on Kaplan-Meier Estimates)
Progression is defined as at least a 20% increase in the sum of diameters of target lesions, in addition the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
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Timepoint [2]
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From randomization to disease progression or death (Up to approximately 65 months)
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Secondary outcome [3]
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Objective Response Rate (ORR)
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Assessment method [3]
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Objective Response Rate (ORR) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria by blinded independent central review (BICR) assessment.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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Timepoint [3]
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From randomization up to approximately 65 months
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Secondary outcome [4]
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Duration of Objective Response (DOR)
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Assessment method [4]
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The time between the first documented response (Complete response (CR) or partial response (PR)) and progression or death, per RECIST 1.1 by blinded independent central review (BICR) assessment. (Based on Kaplan-Meier Estimates)
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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Timepoint [4]
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From randomization to the first documented response (CR or PR) and progression (up to approximately 65 months)
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/10/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
22/09/2022
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Sample size
Target
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Accrual to date
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Final
947
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0142 - Blacktown
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Local Institution - 0127 - Darlinghurst
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Local Institution - 0128 - Gosford
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Local Institution - 0019 - St. Leonards
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Local Institution - 0021 - Elizabeth Vale
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Local Institution - 0131 - Melbourne
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Local Institution - 0020 - Nedlands
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2148 - Blacktown
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2010 - Darlinghurst
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2250 - Gosford
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2065 - St. Leonards
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4102 - Brisbane
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4814 - Douglas
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5112 - Elizabeth Vale
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3168 - Clayton
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3000 - Melbourne
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6009 - Nedlands
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Recruitment outside Australia
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Ono Pharmaceutical Co. Ltd
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Ethics approval
Ethics application status
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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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02741570
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02741570
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