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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02952586




Registration number
NCT02952586
Ethics application status
Date submitted
31/10/2016
Date registered
2/11/2016

Titles & IDs
Public title
Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100)
Scientific title
A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF AVELUMAB IN COMBINATION WITH STANDARD OF CARE CHEMORADIOTHERAPY (CISPLATIN PLUS DEFINITIVE RADIATION THERAPY) VERSUS STANDARD OF CARE CHEMORADIOTHERAPY IN THE FRONT-LINE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
Secondary ID [1] 0 0
2016-001456-21
Secondary ID [2] 0 0
B9991016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of the Head and Neck 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Avelumab
Other interventions - Chemoradiation

Experimental: Avelumab + SOC Chemoradiation Therapy - * Avelumab 10 mg/kg IV: Day 1 of the Lead-in Phase; Days 8, 25, and 39 of the CRT Phase; and Q2W for 12 months during the Maintenance Phase
* Cisplatin 100 mg/m2 IV: Days 1, 22, and 43 of the CRT Phase
* Intensity Modulated Radiation Therapy (IMRT) 70 Gy/35 fractions/7 weeks; 1 fraction per day, 5 fractions/week for 7 weeks during the CRT Phase

Placebo comparator: Placebo + SOC CRT - * Placebo IV matching avelumab: Days 1 of the Lead-in Phase; Days 8, 25, and 39 of the CRT Phase; Q2W for 12 months during the Maintenance Phase
* Cisplatin 100 mg/m2 IV: Days 1, 22, and 43 of the CRT Phase
* IMRT 70 Gy/35 fractions/7 weeks; 1 fraction per day, 5 fractions/week for 7 weeks during the CRT Phase


Treatment: Drugs: Avelumab
Avelumab + SOC Chemoradiation

Other interventions: Chemoradiation
Cisplatin + Radiation Therapy
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as Assessed by Investigator
Timepoint [1] 0 0
From randomization until documented PD or death, censored date, whichever occurred first (up to 37 months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization to the date of death or censored date, whichever occurred first (up to 37 months)
Secondary outcome [2] 0 0
Pathologic Complete Response (pCR) Rate in Participants With Salvage Surgery at the Primary Site
Timepoint [2] 0 0
From randomization until PD or death (up to 37 months)
Secondary outcome [3] 0 0
Time to Locoregional Failure Per Modified RECIST v1.1 as Assessed by Investigator
Timepoint [3] 0 0
From the date of randomization to the date of the first documentation of locoregional recurrence or death, whichever occurred first (up to 37 months)
Secondary outcome [4] 0 0
Objective Response Rate (ORR) Per Modified RECIST v1.1 as Assessed by Investigator
Timepoint [4] 0 0
From randomization until disease progression or death, whichever occurred first (up to 37 months)
Secondary outcome [5] 0 0
Time to Distant Metastatic Failure Per Modified RECIST v1.1 as Assessed by Investigator
Timepoint [5] 0 0
From the date of randomization to the date of the first documentation of distant metastatic or death (up to 37 months)
Secondary outcome [6] 0 0
Duration of Response (DOR) Per Modified RECIST v1.1 as Assessed by Investigator
Timepoint [6] 0 0
From the first documentation of objective tumor response to the first documentation of PD or death or censored date, whichever occurred first (up to 37 months)
Secondary outcome [7] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Graded by National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
Timepoint [7] 0 0
Baseline up to 44 months
Secondary outcome [8] 0 0
Number of Participants With Shift From Baseline in Clinical Laboratory Parameters
Timepoint [8] 0 0
Baseline up to 15 months
Secondary outcome [9] 0 0
Change From Baseline in Vital Sign - Systolic and Diastolic Blood Pressure
Timepoint [9] 0 0
Baseline, Lead-in phase: Day1; CRT Phase: Days 1, 8, 22, 25, 39, and 43; Maintenance phase: on Days 1 and 15 in Cycles 1 to 13 and EOT (3 days after the last dose of study drug)
Secondary outcome [10] 0 0
Change From Baseline in Vital Sign - Pulse Rate
Timepoint [10] 0 0
Baseline, Lead-in phase: Day1; CRT Phase: Days 1, 8, 22, 25, 39, and 43; Maintenance phase: on Days 1 and 15 in Cycles 1 to 13 and EOT (3 days after the last dose of study drug)
Secondary outcome [11] 0 0
Change From Baseline in the European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Index Score at CRT Phase and Maintenance Phase
Timepoint [11] 0 0
Baseline, CRT Phase: Days 1 and 29; Maintenance phase: Cycle 1/Day 1, Cycle 3/Day 1, Cycle 7/Day 1, Cycle 7/Day 15, Cycle 11/Day 1, Cycle 11/Day 15, EOT (3 days after the last dose of study drug)
Secondary outcome [12] 0 0
Change From Baseline in the European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) VAS Score at CRT Phase and Maintenance Phase
Timepoint [12] 0 0
Baseline, CRT Phase: Days 1 and 29; Maintenance phase: Cycle 1/Day 1, Cycle 3/Day 1, Cycle 7/Day 1, Cycle 7/Day 15, Cycle 11/Day 1, Cycle 11/Day 15, EOT (3 days after the last dose of study drug)
Secondary outcome [13] 0 0
Change From Baseline in National Cancer Comprehensive Network Head and Neck Symptom Index-22 Item Scores (NCCN FHNSI-22) at CRT Phase and Maintenance Phase
Timepoint [13] 0 0
Baseline, CRT Phase: Days 1 and 29; Maintenance phase: Cycle 1/Day 1, Cycle 3/Day 1, Cycle 7/Day 1, Cycle 7/Day 15, Cycle 11/Day 1, Cycle 11/Day 15, EOT (3 days after the last dose of study drug)
Secondary outcome [14] 0 0
Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)
Timepoint [14] 0 0
Baseline (prior to first dose)
Secondary outcome [15] 0 0
Mean Percentage (%) of Total Tumor Area Occupied by Cluster of Differentiation 8 (CD8+) Cells
Timepoint [15] 0 0
Baseline (prior to first dose)
Secondary outcome [16] 0 0
Percentage of Participants With Positive and Negative Pathology of Neck Dissection
Timepoint [16] 0 0
From randomization until PD as per investigator assessment (up to 37 months)
Secondary outcome [17] 0 0
Maximum Plasma Concentration (Cmax) of Avelumab
Timepoint [17] 0 0
Pre-dose and end of infusion on Day 1 of lead-in phase, Days 8, 25 of CRT phase, Day 1 of Cycle 1 and 2 (each cycle 28 days)
Secondary outcome [18] 0 0
Predose Plasma Concentration (Ctrough) of Avelumab
Timepoint [18] 0 0
Pre-dose on Day 1 of lead-in phase, Days 8, 25 of CRT phase, Day 1 of Cycle 1, 2, 5, 8, 11 (each cycle 28 days)
Secondary outcome [19] 0 0
Dose Normalized Maximum Plasma Concentration (Cmax [dn]) of Total and Free Cisplastin
Timepoint [19] 0 0
Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase
Secondary outcome [20] 0 0
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of Total and Free Cisplatin
Timepoint [20] 0 0
Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase
Secondary outcome [21] 0 0
Maximum Plasma Concentration (Cmax) of Total and Free Cisplatin
Timepoint [21] 0 0
Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase
Secondary outcome [22] 0 0
Time to Attain Maximum Observed Plasma Concentration (Tmax) of Total and Free Cisplatin
Timepoint [22] 0 0
Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase
Secondary outcome [23] 0 0
Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status
Timepoint [23] 0 0
pre-dose on Day 1 up to 30 Days after the end of treatment
Secondary outcome [24] 0 0
Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status
Timepoint [24] 0 0
Day 1 of lead-in phase and on Days 8 and 25 of CRT phase

Eligibility
Key inclusion criteria
INCLUSION CRITERIA

* Histological diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
* HPV negative disease, Stage III, IVa, IVb; non-oropharyngeal HPV positive disease Stage III, IVa, IVb, HPV positive oropharyngeal disease T4 or N2c or N3
* No prior therapy for advanced stage SCCHN; eligible for definitive CRT with curative intent.
* Available tumor samples for submission or willing to undergo further tumor biopsies:
* Age =18 years (=19 in Korea;20 years in Japan and Taiwan).
* ECOG Performance Status 0 or 1
* Adequate bone marrow function
* Adequate renal function
* Adequate liver function
* Pregnancy test (for patients of childbearing potential) negative at screening

EXCLUSION CRITERIA

* Prior immunotherapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti CTLA 4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways.
* Major surgery 4 weeks prior to randomization.
* Prior malignancy requiring tumor-directed therapy within the last 2 years prior to enrollment, or concurrent malignancy associated with clinical instability. Exceptions for disease within the 2 years are superficial esophageal cancer (TIS or T1a) fully resected by endoscopy, prostate cancer (Gleason score 6) either curatively treated or deemed to not require treatment, ductal IS carcinoma of the breast that has completed curative treatment, adequately treated basal cell or squamous cell skin cancer.
* Active autoimmune disease
* Any of the following in the 6 months prior to randomization: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism.
* Active infection requiring systemic therapy.
* Use of immunosuppressive medication at time of randomization
* Prior organ transplantation including allogenic stem-cell transplantation.
* Diagnosis of prior immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
* Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Vaccination within 4 weeks prior to randomization.
* Current use of or anticipated need for treatment with other anti-cancer drugs.
* Pregnant female patients, breastfeeding female patients, and male patients able to father children and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in the protocol for the duration of the study and for at least 6 months after the last dose of cisplatin and 60 days after the last dose of avelumab/placebo (whichever is later).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/08/2020
Sample size
Target
Accrual to date
Final
697
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse Medical Imaging - Camperdown
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse Radiation Oncology Department - Camperdown
Recruitment hospital [3] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [4] 0 0
Northern Sydney Cancer Centre - St Leonards
Recruitment hospital [5] 0 0
Illawarra Shoalhaven Local Health District - Wollongong
Recruitment hospital [6] 0 0
Barwon Health, University Hospital Geelong - Geelong
Recruitment hospital [7] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
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California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
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Florida
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United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
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Indiana
Country [7] 0 0
United States of America
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Kansas
Country [8] 0 0
United States of America
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nebraska
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New York
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North Carolina
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Oklahoma
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South Carolina
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Washington
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Austria
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Linz
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Belgium
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Brussels
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Charleroi
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Belgium
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Haine Saint Paul
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Belgium
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Namur
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Wilrijk
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China
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China
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Tianjin
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Angers cedex 02
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Avignon cedex 9
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Bordeaux
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Brest
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Montpellier cedex 5
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Nantes cedex 2
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Nice cedex 2
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Saint Herblain Cedex
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Saint Priest en Jarez cedex
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Jena
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Attica
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Thessaloniki
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Budapest
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Debrecen
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Gyor
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Pecs
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Dublin
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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 Tiqva
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Israel
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Ramat Gan
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Italy
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BS
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Italy
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FC
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Italy
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Forlì-cesena
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Italy
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LE
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Italy
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MO
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Italy
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PR
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Italy
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RA
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Italy
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VR
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Italy
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Napoli
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Italy
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Reggio Emilia
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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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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Japan
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Tochigi
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Japan
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Tokyo
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Jeollanam-do
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Korea, Republic of
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Seoul
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Korea, Republic of
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Ulsan
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Gliwice
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Olsztyn
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Poland
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Tomaszow Mazowiecki
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Portugal
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Porto
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Portugal
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Coimbra
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Russian Federation
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Chelyabinsk
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Russian Federation
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Moscow
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Russian Federation
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Omsk
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Yaroslavl
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Spain
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Barcelona
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Spain
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Guipuzcoa
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Spain
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Malaga
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Spain
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Murcia
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Spain
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Cordoba
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Spain
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Girona
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Spain
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Jaen
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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Valencia
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Spain
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Zaragoza
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Switzerland
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Basel-stadt
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Switzerland
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Ticino
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Switzerland
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Vaud
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Switzerland
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Zuerich
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Switzerland
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Zurich
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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United Kingdom
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Aberdeen
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United Kingdom
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Bebington
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United Kingdom
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Bristol
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United Kingdom
State/province [139] 0 0
Edinburgh
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United Kingdom
State/province [140] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


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/NCT02952586