Back to resultsStudy 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)
Primary Purpose
Squamous Cell Carcinoma of the Head and Neck
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Avelumab
Chemoradiation
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck
Eligibility 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).
Sites / Locations
- Highlands Oncology Group
- Highlands Oncology Group
- Highlands Oncology Group
- The Oncology Institute of Hope and Innovation
- CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
- Beverly Hills Cancer Center
- Tower Hematology Oncology Medical Group
- UCSD Radiation Oncology South Bay, Cancer Treatment Centers
- City of Hope Corona
- Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
- The Oncology Institute of Hope and Innovation
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
- The Oncology Institute of Hope and Innovation
- UC San Diego Medical Center- La Jolla (Thornton Hospital)
- UC San Diego Moores Cancer Center
- City of Hope Antelope Valley
- The Oncology Institute of Hope and Innovation
- The Oncology Institute of Hope and Innovation
- Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
- The Oncology Institute of Hope and Innovation
- The Oncology Institute of Hope and Innovation
- UC Irvine Medical Center
- Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
- UC San Diego Medical Center- Hillcrest
- The Oncology Institute of Hope and Innovation
- City of Hope South Pasadena
- The Oncology Institute of Hope and Innovation
- The Oncology Institute of Hope and Innovation
- The Oncology Institute of Hope and Innovation
- Rocky Mountain Lions Eye Institute
- University of Colorado Denver CTO/CTRC
- University of Colorado Hospital - Anschutz Inpatient Pavilion
- University of Colorado Hospital - Anschutz Outpatient Pavilion
- University Of Colorado Hospital Cancer Center
- Cypress Hematology & Oncology
- Cypress Hematology and Oncology
- Sylvester at Coral Gables
- Sylvester at Deerfield Beach
- Specialist Global LLC
- Memorial Cancer Institute at Memorial Regional Hospital
- Hollis Cancer Center
- Sylvester Comprehensive Cancer Center
- Memorial Cancer Institute at Memorial Hospital West
- Sylvester at Plantation
- H. Lee Moffitt Cancer Center and Research Institute
- Primary Healthcare Associates
- Ingalls Memorial Hospital
- Primary Healthcare Associates
- Primary Healthcare Associates
- IU Health Arnett Cancer Center
- Kansas City VA Radiation Oncology Clinic
- Ashland-Bellefonte Cancer Center
- Norton Cancer Institute
- Norton Hospital
- University Medical Center, Inc.
- Norton Brownsboro Hospital
- Norton Cancer Institute
- Highlands Cancer Center
- Maryland Proton Treatment Center
- University of Maryland School of Medicine
- University of Maryland, Greenebaum Comprehensive Cancer Center
- Dana-Farber Cancer Institute
- Karmanos Cancer Institute
- Henry Ford Hospital
- Karmanos Cancer Institute
- Herbert-Herman Cancer Center, Sparrow Hospital
- University of Missouri- Ellis Fischel Cancer Center
- Siteman Cancer Center - West County
- Kansas City VA Medical Center
- Barnes-Jewish Hospital
- Washington University School of Medicine Siteman Cancer Center
- Siteman Cancer Center - South County
- Siteman Cancer Center- St. Peters
- Department of Radiation Oncology Methodist Hospital
- Oncology Hematology West, PC dba Nebraska Cancer Specialists
- Memorial Sloan Kettering Cancer Center-Basking Ridge
- Hackensack University Medical Center
- John Theurer Cancer Center at Hackensack University Medical Center
- Memorial Sloan Kettering Cancer Center- Monmouth
- Memorial Sloan Kettering Cancer Center- Bergen
- University of New Mexico Comprehensive Cancer Center
- Montefiore-Einstein Center for Cancer Care
- Montefiore Medical Center
- Memorial Sloan Kettering Cancer Center Commack
- Memorial Sloan Kettering Cancer Center Westchester
- Bellevue Hospital Center
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- NYU Langone Medical Center
- NYU Langone Radiology
- NYU Langone Radiology - Ambulatory Care Center East 41st Street
- Memorial Sloan Kettering Cancer Center
- Memorial Sloan Kettering Cancer Center: Breast and Imaging Center
- Memorial Sloan Kettering Cancer Center
- Stony Brook University
- Stony Brook Cancer Center
- Memorial Sloan Kettering Cancer Center- Nassau
- Oncology Specialists of Charlotte, PA
- DJL Clinical Research, PLLC
- Wake Forest Baptist Health
- University Hospitals Cleveland Medical Center
- OU Medical Center
- Stephenson Cancer Center
- University of Oklahoma Health Sciences Center- Stephenson Cancer Center
- Lehigh Valley Health Network Cancer Center Pharmacy
- Lehigh Valley Health Network-Cedar Crest
- Radiation Oncology Cancer Services
- Lehigh Valley Health Network-Muhlenberg
- Precision Cancer Research / Gettysburg Cancer Center
- PinnacleHealth Cancer Institute
- PinnacleHealth Cancer Institute
- Fox Chase Cancer Center
- UPMC Hillman Cancer Center
- UPMC Shadyside Radiation Oncology
- MUSC- Rutledge Tower
- Medical University of South Carolina- Hollings Cancer Center
- MUSC SCTR Research Nexus Clinical Science Building
- MUSC- Ashley River Tower
- MUSC- Radiation Oncology
- MUSC- University Hospital
- GHS Cancer Institute
- GHS Cancer Institute
- GHS Cancer Institute
- GHS Cancer Institute
- GHS Cancer Institute
- GHS Cancer Institute
- The West Clinic, PC dba West Cancer Center
- The West Clinic PC dba West Cancer Center
- Henry-Joyce Cancer Clinic
- Texas Oncology El Paso Cancer Treatment Center
- William Beaumont Army Medical Center
- William Beaumont Army Medical Center
- University of Texas Medical Branch
- Memorial Hermann Hospital - TMC
- UTHealth/Memorial Hermann Cancer Center
- UTMB Cancer Center at Victory Lakes
- Utah Cancer Specialists
- Utah Cancer Specialists
- Virginia Mason Medical Center
- VA Puget Sound Health Care System
- Chris O'Brien Lifehouse Medical Imaging
- Chris O'Brien Lifehouse Radiation Oncology Department
- Chris O'Brien Lifehouse
- Northern Sydney Cancer Centre
- Illawarra Shoalhaven Local Health District
- Barwon Health, University Hospital Geelong
- Austin Health
- Ordensklinikum Linz GmbH
- University Hospital Brussels
- Grand Hopital de Charleroi - Site Notre-Dame
- Centre Hospitalier de Jolimont
- Site Sainte Elisabeth / CHU UCL Namur
- GZA Hospitals Campus Sint Augustinus
- CHU de Quebec - Universite Laval
- Beijing Cancer Hospital
- Fujian Cancer Hospital
- SUN Yat-Sen University Cancer Center
- Cancer Center of Guangzhou Medical University/Oncology Department
- Affiliated Tumor Hospital of Guangxi Medical University
- Hai Nan General Hospital
- Harbin Medical University Cancer Hospital
- Henan Cancer Hospital
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center
- Xiangya Hospital Central South University/Oncology Department
- Liaoning Cancer Hospital & Institute
- Fudan University Shanghai Cancer Center
- Shanghai East Hospital/Oncology Department
- West China Hospital of Sichuan University
- Tianjin Cancer Hospital
- Institut de Cancerologie de l'Ouest (ICO) - Site Paul Papin
- Institut Sainte Catherine
- Hopital Pellegrin - Service de radiologie et d'imagerie
- Hopital Saint-Andre
- Cabinet de radiologie Privé - Dr Joseph Mocaer
- Clinique Pasteur - CFRO
- Hopital Franco-Britannique, Institut d'Oncologie Hauts-de-Seine Nord
- Institut Regional du Cancer Montpellier - Val d'Aurelle
- Hopital prive du Confluent S.A.S.
- Hopital prive du Confluent S.A.S
- Clinique Hartmann
- Hopital Americain de Paris
- Centre Antoine Lacassagne
- Institut Curie
- Centre Hospitalier Prive Saint Gregoire
- Institut de Cancerologie de l'Ouest (ICO) - Site Rene Gauducheau
- Institut de cancerologie de la Loire Lucien Neuwirth
- Centre Paul Strauss - Radiologie et medecine nucleaire
- ICANS - Institut de cancerologie Strasbourg Europe
- Institut Gustave Roussy
- Helios Klinikum Berlin-Buch, Institut fur Rontgendiagnostik
- Helios Klinikum Berlin-Buch, Klinik fur Nuklearmedizin
- Helios Klinikum Berlin-Buch, Klinik fur Strahlentherapie
- Helios Klinikum Berlin-Buch
- Universitatsklinikum Dusseldorf
- Universitatsklinikum Jena
- Universitatsklinikum Jena
- Universitätsklinikum Regensburg
- General Oncology Hospital of Kifissia "Agioi Anargiroi"
- Attikon University Hospital
- Euromedica General Clinic
- Orszagos Onkologiai Intezet, B Belgyogyaszati Osztaly
- Orszagos Onkologiai Intezet, Sugarterapias Osztaly
- Uzsoki Utcai Korhaz
- Debreceni Egyetem Klinikai Kozpont
- Petz Aladar Megyei Oktato Koraz, Onkoradiologiai osztaly
- Pecsi Tudomanyegyetem, Klinikai Kozpont, Onkoterapias Intezet
- Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont
- St Luke's Radiation Oncology Network, St Luke's Hospital
- St James's Hospital
- St. James's Hospital
- Blackrock Clinic
- Rambam Health Care Campus
- Hadassah University Hospital, Department of Oncology
- Rabin Medical Center
- The Chaim Sheba M.C.Tel-Hashomer
- ASST degli Spedali Civili di Brescia
- Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (I.R.S.T)
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
- Ospedale M. Bufalini
- IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
- Presidio Ospedaliero Vito Fazzi
- AOU Policlinico Di Modena
- Azienda Ospedaliero-Universitaria di Parma
- UOC Oncologia Medica, AUSL della Romagna -RAVENNA
- IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
- UOC Oncologia Medica, AUSL della Romagna - RAVENNA
- AULSS 9 - Scaligera Ospedale Mater Salutis
- Istituto Nazionale Tumori IRCCS - Fondazione Pascale
- AUSL - IRCCS and Reggio Emilia
- Aichi cancer center central hospital
- Nagoya University Hospital
- National Cancer Center Hospital East
- National Hospital Organization Shikoku Cancer Center
- Hokkaido University Hospital
- Kobe University Hospital
- Miyagi Cancer Center
- Tohoku University Hospital
- Osaka International Cancer Institute
- Kindai University Hospital
- Saitama Cancer Center
- Shizuoka Cancer Center
- Jichi Medical University Hospital
- National Cancer Center Hospital
- Cancer Institute Hospital, Japanese Foundation for Cancer Research
- Center for Proton Therapy, National Cancer Center
- Center for Specific Organ Cancer, National Cancer Center
- Department of Radiation Oncology, CHA Bundang Medical Center, CHA University
- Seoul National University Bundang Hospital
- Chonnam National University Hwasun Hospital
- Division of Radiation Oncology, Seoul National University Hospital
- Asan Medical Center
- Division of Radiation Oncology, Asan Medical Center
- Samsung Medical Center
- SMG-SNU Boramae Medical Center
- Department of Radiation Oncology, Ulsan University Hospital
- Ulsan University Hospital
- Centrum Onkologii im. prof. F. Lukaszczyka
- Uniwersyteckie Centrum Kliniczne
- Centrum Onkologii - Instytut im. M. Sklodowskiej - Curie, Klinika Radioterapii i Chemioterapii
- SPZOZ Ministerstwa Spraw Wewnetrznych i Administracji z Warminsko-Mazurskim Centrum Onkologii
- NZOZ Provita Prolife Centrum Medyczne
- Specjalistyczny Szpital Onkologiczny NU-MED sp. z o.o.
- Hospital Pedro Hispano
- CUF Porto
- Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
- Instituto Portugues de Oncologia de Coimbra Francisco Gentil, E.P.E.
- Centro Hospitalar do Porto, E.P.E.- Hospital de Santo Antonio
- Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
- Centro Hospitalar São João, E.P.E
- Julio Teixeira
- SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"
- N. N. Blokhin NMRCO
- Budgetary Institution of Healthcare of Omsk Region "Clinical Oncology Dispensary"
- FSBI "National Medical Research Center of Oncology n.a. N.N. Petrov"
- SBIH "SPb Clinical Research Centre of Specialized Kinds of Medical Care (Oncology)"
- SBHI YaR "Regional Clinical Oncology Hospital"
- Institut Catala d'Oncologia Badalona, Hospital Germans Trias i Pujol
- Hospital Universitario Donostia
- Hospital Costa del Sol
- Hospital Clinico Universitario Virgen de la Arrixaca
- Hospital Universitari Vall d'Hebron
- Hospital Clinic de Barcelona
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitario Reina Sofia
- Institut Catala D'Oncologia de Girona
- Complejo Hospitalario de Jaen
- Hospital Clinico San Carlos
- Hospital Universitario La Paz
- Hospital Virgen de la Victoria
- Hospital Universitario de Salamanca
- Fundacion Instituto Valenciano de Oncologia
- Hospital Clinico Universitario Lozano Blesa
- Klinik fur Radiologie und Nuklearmedizin
- Klinik fur Strahlentherapie und Radioonkologie
- Universitatsspital Basel
- Istituto Oncologico della Svizzera Italiana IOSI, Ospedale San Giovanni
- Radiologia ORBV, Ospedale San Giovanni
- Centre Hospitalier Universitaire Vaudois
- Kantonsspital Winterthur, Medizinische Onkologie
- Kantonsspital Winterthur, Radiologie
- Kantonsspital Winterthur
- Institut fur Klinische Pathologie
- Klinik fur Nuklearmedizin
- Universitatsspital Zurich
- China Medical University Hospital
- Taichung Veterans General Hospital
- National Cheng Kung University Hospital
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Koo Foundation Sun Yat-Sen Cancer Center
- Chang Gung Memorial Hospital-Linkou Branch
- NHS Grampian
- The Clatterbridge Cancer Centre NHS Foundation Trust
- University Hospital Bristol NHS Foundation Trust
- NHS Lothian, Western General Hospital
- Guy's and St. Thomas' NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Avelumab + SOC Chemoradiation Therapy
Placebo + SOC CRT
Arm Description
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 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
Outcomes
Primary Outcome Measures
Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as Assessed by Investigator
PFS was defined as the time (in months) from the date of randomization to the first documentation of objective progressive disease (PD) per modified RECIST v1.1 as assessed by Investigator or death (due to any cause), whichever occurred first. Analysis was performed using Kaplan Meier method. PD refers to any of following: 1) Locoregional PD confirmed by pathology to verify radiographic changes represent true tumor progression and not radiation effects or non-malignant contrast enhancement. 2) Locoregional clinically detectable progression confirmed by pathology. 3) Surgical removal (salvage) of primary tumor with tumor present on final pathology. 4) Salvage neck dissection greater than (>) 20 weeks after completion of CRT with tumor present on final pathology. 5) Metastatic PD. PFS data was censored on date of last adequate tumor assessment for participants with no PFS event.
Secondary Outcome Measures
Overall Survival (OS)
Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan Meier method.
Pathologic Complete Response (pCR) Rate in Participants With Salvage Surgery at the Primary Site
pCR was defined as the absence of histologically identifiable residual cancer in any resected specimen. The pCR rate at primary site was estimated by dividing the number of participants with pCR recorded at any visit from randomization until PD per modified RECIST v1.1 or death due to any cause by the number of participants randomized who had salvage surgery at the primary site.
Time to Locoregional Failure Per Modified RECIST v1.1 as Assessed by Investigator
Locoregional failure was defined as the time from the date of randomization to the date of the first documentation of locoregional recurrence or death due to any cause per modified RECIST v1.1 as assessed by Investigator, whichever occurred first. Analysis was performed using Kaplan Meier method.
Objective Response Rate (ORR) Per Modified RECIST v1.1 as Assessed by Investigator
Objective response (OR) was defined as a complete response (CR) or partial response (PR) per RECIST v1.1 recorded from randomization until disease progression per modified RECIST v1.1 or death due to any cause. A participant was considered to have achieved an OR if the participant had a CR or PR which did not need to be confirmed at a subsequent assessment. CR for target disease: complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis less than [<] 10 millimeter [mm]). CR for non-target disease: disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be 'normal' in size (<10 mm short axis) . PR: Greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target measurable lesions. The ORR was estimated by dividing the number of participants with OR (CR or PR) by the number of participants randomized.
Time to Distant Metastatic Failure Per Modified RECIST v1.1 as Assessed by Investigator
Time to distant metastatic failure or distant metastasis (DM) was defined as the time from the date of randomization to the date of the first documentation of distant metastatic or death due to any cause, whichever occurred first. Distant metastatic disease was defined as new tumor identified at a site distant from the head and neck anatomic region or draining lymph nodes. Analysis was performed using Kaplan Meier method.
Duration of Response (DOR) Per Modified RECIST v1.1 as Assessed by Investigator
DOR:time from first documentation of objective tumor response (CR/PR) to first documentation of PD/death due to any cause, whichever occurred first.PR:>=30% decrease under baseline of sum of diameters of all target measurable lesions. CR for target disease:complete disappearance of all target lesions with exception of nodal disease.CR for non-target disease: disappearance of all non-target lesions and normalization of tumor marker levels. PD is any of following:1)Locoregional PD confirmed by pathology to verify radiographic changes denote true tumor progression and not radiation effects or non-malignant contrast enhancement.2)Locoregional clinically detectable progression confirmed by pathology.3)Surgical removal of primary tumor with tumor present on final pathology.4)Salvage neck dissection >20 weeks after completion of CRT with tumor present on final pathology.5)Metastatic PD. DOR data was censored on date of last adequate tumor assessment for participants with no overall response.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Graded by National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. TEAE was defined as event with onset dates occurring during the on-treatment period.
Number of Participants With Shift From Baseline in Clinical Laboratory Parameters
Grade 1 and 3 ranges are: Anemia:Hb:<LLN-10.0,<8.0 g/dL;LC decreased (dec):<LLN-800/mm^3,500-200/mm^3;LC increased (inc):grade 3:>20,000/mm^3:NC dec:<LLN-1500/mm^3;<1000-500/mm^3;PC dec:<LLN-75,000/mm^3;<50,000-25,000/mm^3;WBC dec:<LLN-3000/mm^3;<2000-1000/mm^3;ALT inc:>ULN-3.0*ULN;>5.0-20.0*ULN;ALP & GGT inc:>ULN-2.5*ULN;>5.0-20.0*ULN;AST inc:>ULN-3.0*ULN;>5.0-20.0*ULN;BB inc:>ULN-1.5*ULN;>3.0-10.0*ULN;CH high:>ULN-300 mg/dL;>400-500 mg/dL;CPK inc:>ULN-2.5*ULN;>5*ULN-10*ULN;Hypercalcemia:>ULN-11.5;>12.5-13.5mg/dL;Hyperglycemia:>ULN-160; >250-500mg/dL;Hyperkalemia:>ULN-5.5;>6.0-7.0mmol/L;Hypermagnesemia:>ULN-3.0;>3.0-8.0 mg/dL;Hypernatremia:>ULN-150; >155-160 mmol/L;Hypertriglyceridemia;150-300;>500-1000 mg/dL;Hypoalbuminemia:<LLN-3;<2g/dL;Hypocalcemia:<LLN-8.0;<8.0-7.0mg/dL;Hypokalemia:<LLN-3.0;<3.0-2.5mmol/L;Hypomagnesemia;<LLN-1.2;<0.9-0.7 mg/dL;Hyponatremia:<LLN-130;<130-120mmol/L; Hypophosphatemia:<LLN-2.5;<2.0-1.0mg/dL;lipase & serum amylase inc:>ULN-1.5*ULN;>2.0-5.0*ULN.
Change From Baseline in Vital Sign - Systolic and Diastolic Blood Pressure
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) measured in sitting position were reported.
Change From Baseline in Vital Sign - Pulse Rate
Change from baseline in pulse rate in sitting position in beats per minute was reported.
Change From Baseline in the European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Index Score at CRT Phase and Maintenance Phase
EQ-5D-5L is a standardized participant completed questionnaire that measures health status in terms of a single index value or utility score. EQ-5D-5L consisted of two components: a health state profile (descriptive system) and a visual analogue scale (VAS) in which participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable), where higher scores indicated better health status. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L health status index score range between 0 to 1. Higher score indicated better health status.
Change From Baseline in the European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) VAS Score at CRT Phase and Maintenance Phase
EQ-5D-5L is a standardized participant completed questionnaire that measures health status in terms of a single index value or utility score. EQ-5D-5L consisted of two components: a health state profile (descriptive system) and a visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L health status index score range between 0 to 1. Higher score indicated worse health status. In VAS participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable), where higher scores indicated better health status.
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
The NCCN FHNSI-22 questionnaire measured disease symptoms, treatment side effects and overall quality of life in participants with head and neck cancer. The questionnaire contained 22 items with 5-point Likert scales ranging from 0 to 4 as follows: 'not at all = 0', a little bit = 1, somewhat = 2, quite a bit = 3 and very much = 4. Total score ranged from 0 to 88 where, higher scores represented better symptomatology, quality of life or functioning.
Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)
PD-L1 biomarker expression in tumor tissue as assessed by IHC in the form of positive immune cells and tumor staining cells.
Mean Percentage (%) of Total Tumor Area Occupied by Cluster of Differentiation 8 (CD8+) Cells
Description: CD8+ cells are the type of T-lymphocytes. Mean percentage of total tumor area occupied by CD8+ Cells has been reported. Area was measured in millimeter square (mm^2).
Percentage of Participants With Positive and Negative Pathology of Neck Dissection
Percentage of participants with positive and negative pathology of neck dissection were reported. Positive pathology included live tumor cells present or 10% or greater vital tumor tissues. Negative pathology included no live tumor cells present, complete tumor regression, no evidence of vital tumor tissues, less than 10% vital tumor tissue, or not consistent with disease under study.
Maximum Plasma Concentration (Cmax) of Avelumab
Maximum observed plasma concentration (Cmax) of Avelumab is reported.
Predose Plasma Concentration (Ctrough) of Avelumab
Ctrough refers to plasma concentration of Avelumab observed just before treatment administration.
Dose Normalized Maximum Plasma Concentration (Cmax [dn]) of Total and Free Cisplastin
Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of total and free Cisplastin (in mg) administered to a participant.
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of Total and Free Cisplatin
Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast). AUClast (dn) was calculated by dividing AUClast by the exact dose of cisplastin (in mg) administered to a participant.
Maximum Plasma Concentration (Cmax) of Total and Free Cisplatin
Maximum observed plasma concentration (Cmax) of total and free Cisplatin is reported.
Time to Attain Maximum Observed Plasma Concentration (Tmax) of Total and Free Cisplatin
Time to reach maximum observed plasma concentration (Tmax) of total and free Cisplatin.
Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status
ADA never-positive was defined as no positive ADA results at any time point; ADA-negative participants (titer less than< cut point) and ADA ever-positive was defined as at least one positive ADA result at any time point; ADA-positive participants (titer greater than or equal to cut point)
Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02952586
Brief 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)
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
The trial prematurely terminated as recommended by the E-DMC because the boundary for futility has been crossed.
Study Start Date
November 28, 2016 (Actual)
Primary Completion Date
December 23, 2019 (Actual)
Study Completion Date
August 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
697 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Avelumab + SOC Chemoradiation Therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo + SOC CRT
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Avelumab
Intervention Description
Avelumab + SOC Chemoradiation
Intervention Type
Other
Intervention Name(s)
Chemoradiation
Intervention Description
Cisplatin + Radiation Therapy
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as Assessed by Investigator
Description
PFS was defined as the time (in months) from the date of randomization to the first documentation of objective progressive disease (PD) per modified RECIST v1.1 as assessed by Investigator or death (due to any cause), whichever occurred first. Analysis was performed using Kaplan Meier method. PD refers to any of following: 1) Locoregional PD confirmed by pathology to verify radiographic changes represent true tumor progression and not radiation effects or non-malignant contrast enhancement. 2) Locoregional clinically detectable progression confirmed by pathology. 3) Surgical removal (salvage) of primary tumor with tumor present on final pathology. 4) Salvage neck dissection greater than (>) 20 weeks after completion of CRT with tumor present on final pathology. 5) Metastatic PD. PFS data was censored on date of last adequate tumor assessment for participants with no PFS event.
Time Frame
From randomization until documented PD or death, censored date, whichever occurred first (up to 37 months)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan Meier method.
Time Frame
From randomization to the date of death or censored date, whichever occurred first (up to 37 months)
Title
Pathologic Complete Response (pCR) Rate in Participants With Salvage Surgery at the Primary Site
Description
pCR was defined as the absence of histologically identifiable residual cancer in any resected specimen. The pCR rate at primary site was estimated by dividing the number of participants with pCR recorded at any visit from randomization until PD per modified RECIST v1.1 or death due to any cause by the number of participants randomized who had salvage surgery at the primary site.
Time Frame
From randomization until PD or death (up to 37 months)
Title
Time to Locoregional Failure Per Modified RECIST v1.1 as Assessed by Investigator
Description
Locoregional failure was defined as the time from the date of randomization to the date of the first documentation of locoregional recurrence or death due to any cause per modified RECIST v1.1 as assessed by Investigator, whichever occurred first. Analysis was performed using Kaplan Meier method.
Time Frame
From the date of randomization to the date of the first documentation of locoregional recurrence or death, whichever occurred first (up to 37 months)
Title
Objective Response Rate (ORR) Per Modified RECIST v1.1 as Assessed by Investigator
Description
Objective response (OR) was defined as a complete response (CR) or partial response (PR) per RECIST v1.1 recorded from randomization until disease progression per modified RECIST v1.1 or death due to any cause. A participant was considered to have achieved an OR if the participant had a CR or PR which did not need to be confirmed at a subsequent assessment. CR for target disease: complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis less than [<] 10 millimeter [mm]). CR for non-target disease: disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be 'normal' in size (<10 mm short axis) . PR: Greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target measurable lesions. The ORR was estimated by dividing the number of participants with OR (CR or PR) by the number of participants randomized.
Time Frame
From randomization until disease progression or death, whichever occurred first (up to 37 months)
Title
Time to Distant Metastatic Failure Per Modified RECIST v1.1 as Assessed by Investigator
Description
Time to distant metastatic failure or distant metastasis (DM) was defined as the time from the date of randomization to the date of the first documentation of distant metastatic or death due to any cause, whichever occurred first. Distant metastatic disease was defined as new tumor identified at a site distant from the head and neck anatomic region or draining lymph nodes. Analysis was performed using Kaplan Meier method.
Time Frame
From the date of randomization to the date of the first documentation of distant metastatic or death (up to 37 months)
Title
Duration of Response (DOR) Per Modified RECIST v1.1 as Assessed by Investigator
Description
DOR:time from first documentation of objective tumor response (CR/PR) to first documentation of PD/death due to any cause, whichever occurred first.PR:>=30% decrease under baseline of sum of diameters of all target measurable lesions. CR for target disease:complete disappearance of all target lesions with exception of nodal disease.CR for non-target disease: disappearance of all non-target lesions and normalization of tumor marker levels. PD is any of following:1)Locoregional PD confirmed by pathology to verify radiographic changes denote true tumor progression and not radiation effects or non-malignant contrast enhancement.2)Locoregional clinically detectable progression confirmed by pathology.3)Surgical removal of primary tumor with tumor present on final pathology.4)Salvage neck dissection >20 weeks after completion of CRT with tumor present on final pathology.5)Metastatic PD. DOR data was censored on date of last adequate tumor assessment for participants with no overall response.
Time Frame
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)
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Graded by National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
Description
Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. TEAE was defined as event with onset dates occurring during the on-treatment period.
Time Frame
Baseline up to 44 months
Title
Number of Participants With Shift From Baseline in Clinical Laboratory Parameters
Description
Grade 1 and 3 ranges are: Anemia:Hb:<LLN-10.0,<8.0 g/dL;LC decreased (dec):<LLN-800/mm^3,500-200/mm^3;LC increased (inc):grade 3:>20,000/mm^3:NC dec:<LLN-1500/mm^3;<1000-500/mm^3;PC dec:<LLN-75,000/mm^3;<50,000-25,000/mm^3;WBC dec:<LLN-3000/mm^3;<2000-1000/mm^3;ALT inc:>ULN-3.0*ULN;>5.0-20.0*ULN;ALP & GGT inc:>ULN-2.5*ULN;>5.0-20.0*ULN;AST inc:>ULN-3.0*ULN;>5.0-20.0*ULN;BB inc:>ULN-1.5*ULN;>3.0-10.0*ULN;CH high:>ULN-300 mg/dL;>400-500 mg/dL;CPK inc:>ULN-2.5*ULN;>5*ULN-10*ULN;Hypercalcemia:>ULN-11.5;>12.5-13.5mg/dL;Hyperglycemia:>ULN-160; >250-500mg/dL;Hyperkalemia:>ULN-5.5;>6.0-7.0mmol/L;Hypermagnesemia:>ULN-3.0;>3.0-8.0 mg/dL;Hypernatremia:>ULN-150; >155-160 mmol/L;Hypertriglyceridemia;150-300;>500-1000 mg/dL;Hypoalbuminemia:<LLN-3;<2g/dL;Hypocalcemia:<LLN-8.0;<8.0-7.0mg/dL;Hypokalemia:<LLN-3.0;<3.0-2.5mmol/L;Hypomagnesemia;<LLN-1.2;<0.9-0.7 mg/dL;Hyponatremia:<LLN-130;<130-120mmol/L; Hypophosphatemia:<LLN-2.5;<2.0-1.0mg/dL;lipase & serum amylase inc:>ULN-1.5*ULN;>2.0-5.0*ULN.
Time Frame
Baseline up to 15 months
Title
Change From Baseline in Vital Sign - Systolic and Diastolic Blood Pressure
Description
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) measured in sitting position were reported.
Time Frame
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)
Title
Change From Baseline in Vital Sign - Pulse Rate
Description
Change from baseline in pulse rate in sitting position in beats per minute was reported.
Time Frame
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)
Title
Change From Baseline in the European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Index Score at CRT Phase and Maintenance Phase
Description
EQ-5D-5L is a standardized participant completed questionnaire that measures health status in terms of a single index value or utility score. EQ-5D-5L consisted of two components: a health state profile (descriptive system) and a visual analogue scale (VAS) in which participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable), where higher scores indicated better health status. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L health status index score range between 0 to 1. Higher score indicated better health status.
Time Frame
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)
Title
Change From Baseline in the European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) VAS Score at CRT Phase and Maintenance Phase
Description
EQ-5D-5L is a standardized participant completed questionnaire that measures health status in terms of a single index value or utility score. EQ-5D-5L consisted of two components: a health state profile (descriptive system) and a visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L health status index score range between 0 to 1. Higher score indicated worse health status. In VAS participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable), where higher scores indicated better health status.
Time Frame
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)
Title
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
Description
The NCCN FHNSI-22 questionnaire measured disease symptoms, treatment side effects and overall quality of life in participants with head and neck cancer. The questionnaire contained 22 items with 5-point Likert scales ranging from 0 to 4 as follows: 'not at all = 0', a little bit = 1, somewhat = 2, quite a bit = 3 and very much = 4. Total score ranged from 0 to 88 where, higher scores represented better symptomatology, quality of life or functioning.
Time Frame
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)
Title
Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)
Description
PD-L1 biomarker expression in tumor tissue as assessed by IHC in the form of positive immune cells and tumor staining cells.
Time Frame
Baseline (prior to first dose)
Title
Mean Percentage (%) of Total Tumor Area Occupied by Cluster of Differentiation 8 (CD8+) Cells
Description
Description: CD8+ cells are the type of T-lymphocytes. Mean percentage of total tumor area occupied by CD8+ Cells has been reported. Area was measured in millimeter square (mm^2).
Time Frame
Baseline (prior to first dose)
Title
Percentage of Participants With Positive and Negative Pathology of Neck Dissection
Description
Percentage of participants with positive and negative pathology of neck dissection were reported. Positive pathology included live tumor cells present or 10% or greater vital tumor tissues. Negative pathology included no live tumor cells present, complete tumor regression, no evidence of vital tumor tissues, less than 10% vital tumor tissue, or not consistent with disease under study.
Time Frame
From randomization until PD as per investigator assessment (up to 37 months)
Title
Maximum Plasma Concentration (Cmax) of Avelumab
Description
Maximum observed plasma concentration (Cmax) of Avelumab is reported.
Time Frame
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)
Title
Predose Plasma Concentration (Ctrough) of Avelumab
Description
Ctrough refers to plasma concentration of Avelumab observed just before treatment administration.
Time Frame
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)
Title
Dose Normalized Maximum Plasma Concentration (Cmax [dn]) of Total and Free Cisplastin
Description
Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of total and free Cisplastin (in mg) administered to a participant.
Time Frame
Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase
Title
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of Total and Free Cisplatin
Description
Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast). AUClast (dn) was calculated by dividing AUClast by the exact dose of cisplastin (in mg) administered to a participant.
Time Frame
Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase
Title
Maximum Plasma Concentration (Cmax) of Total and Free Cisplatin
Description
Maximum observed plasma concentration (Cmax) of total and free Cisplatin is reported.
Time Frame
Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase
Title
Time to Attain Maximum Observed Plasma Concentration (Tmax) of Total and Free Cisplatin
Description
Time to reach maximum observed plasma concentration (Tmax) of total and free Cisplatin.
Time Frame
Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase
Title
Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status
Description
ADA never-positive was defined as no positive ADA results at any time point; ADA-negative participants (titer less than< cut point) and ADA ever-positive was defined as at least one positive ADA result at any time point; ADA-positive participants (titer greater than or equal to cut point)
Time Frame
pre-dose on Day 1 up to 30 Days after the end of treatment
Title
Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status
Time Frame
Day 1 of lead-in phase and on Days 8 and 25 of CRT phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Highlands Oncology Group
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Beverly Hills Cancer Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Tower Hematology Oncology Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
UCSD Radiation Oncology South Bay, Cancer Treatment Centers
City
Chula Vista
State/Province
California
ZIP/Postal Code
91914
Country
United States
Facility Name
City of Hope Corona
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
Facility Name
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
UC San Diego Medical Center- La Jolla (Thornton Hospital)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
City of Hope Antelope Valley
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Lynwood
State/Province
California
ZIP/Postal Code
90262
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868-3201
Country
United States
Facility Name
Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
UC San Diego Medical Center- Hillcrest
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
City of Hope South Pasadena
City
South Pasadena
State/Province
California
ZIP/Postal Code
91030
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
Rocky Mountain Lions Eye Institute
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Denver CTO/CTRC
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital - Anschutz Inpatient Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital - Anschutz Outpatient Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University Of Colorado Hospital Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Cypress Hematology & Oncology
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Cypress Hematology and Oncology
City
Parker
State/Province
Colorado
ZIP/Postal Code
80138
Country
United States
Facility Name
Sylvester at Coral Gables
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Sylvester at Deerfield Beach
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33442
Country
United States
Facility Name
Specialist Global LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Memorial Cancer Institute at Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Hollis Cancer Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Memorial Cancer Institute at Memorial Hospital West
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Sylvester at Plantation
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Primary Healthcare Associates
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Primary Healthcare Associates
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Primary Healthcare Associates
City
Tinley Park
State/Province
Illinois
ZIP/Postal Code
60477
Country
United States
Facility Name
IU Health Arnett Cancer Center
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47904
Country
United States
Facility Name
Kansas City VA Radiation Oncology Clinic
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Ashland-Bellefonte Cancer Center
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Norton Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University Medical Center, Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Norton Brownsboro Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Highlands Cancer Center
City
Prestonsburg
State/Province
Kentucky
ZIP/Postal Code
41653
Country
United States
Facility Name
Maryland Proton Treatment Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Maryland, Greenebaum Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Karmanos Cancer Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Herbert-Herman Cancer Center, Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
University of Missouri- Ellis Fischel Cancer Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Siteman Cancer Center - West County
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Kansas City VA Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Siteman Cancer Center - South County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Facility Name
Siteman Cancer Center- St. Peters
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Department of Radiation Oncology Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Oncology Hematology West, PC dba Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center-Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center- Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center- Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
University of New Mexico Comprehensive Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Montefiore-Einstein Center for Cancer Care
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Bellevue Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Langone Radiology
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Langone Radiology - Ambulatory Care Center East 41st Street
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center: Breast and Imaging Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-7007
Country
United States
Facility Name
Stony Brook Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center- Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Facility Name
Oncology Specialists of Charlotte, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
DJL Clinical Research, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
OU Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Oklahoma Health Sciences Center- Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Lehigh Valley Health Network Cancer Center Pharmacy
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Lehigh Valley Health Network-Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Radiation Oncology Cancer Services
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Lehigh Valley Health Network-Muhlenberg
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Precision Cancer Research / Gettysburg Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
PinnacleHealth Cancer Institute
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17109
Country
United States
Facility Name
PinnacleHealth Cancer Institute
City
Mechancisburg
State/Province
Pennsylvania
ZIP/Postal Code
17050
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
UPMC Shadyside Radiation Oncology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
MUSC- Rutledge Tower
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Medical University of South Carolina- Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
MUSC SCTR Research Nexus Clinical Science Building
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
MUSC- Ashley River Tower
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
MUSC- Radiation Oncology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
MUSC- University Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
GHS Cancer Institute
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
GHS Cancer Institute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
GHS Cancer Institute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
GHS Cancer Institute
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
GHS Cancer Institute
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Facility Name
GHS Cancer Institute
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
Facility Name
The West Clinic, PC dba West Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
The West Clinic PC dba West Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Henry-Joyce Cancer Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Oncology El Paso Cancer Treatment Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
William Beaumont Army Medical Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79920-5001
Country
United States
Facility Name
William Beaumont Army Medical Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79920
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Memorial Hermann Hospital - TMC
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
UTHealth/Memorial Hermann Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
UTMB Cancer Center at Victory Lakes
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Utah Cancer Specialists
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Chris O'Brien Lifehouse Medical Imaging
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Chris O'Brien Lifehouse Radiation Oncology Department
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Northern Sydney Cancer Centre
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Illawarra Shoalhaven Local Health District
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Barwon Health, University Hospital Geelong
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Ordensklinikum Linz GmbH
City
Linz
ZIP/Postal Code
A-4010
Country
Austria
Facility Name
University Hospital Brussels
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Grand Hopital de Charleroi - Site Notre-Dame
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Centre Hospitalier de Jolimont
City
Haine Saint Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Site Sainte Elisabeth / CHU UCL Namur
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
GZA Hospitals Campus Sint Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
CHU de Quebec - Universite Laval
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
SUN Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Cancer Center of Guangzhou Medical University/Oncology Department
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China
Facility Name
Affiliated Tumor Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Hai Nan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Xiangya Hospital Central South University/Oncology Department
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai East Hospital/Oncology Department
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200123
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Institut de Cancerologie de l'Ouest (ICO) - Site Paul Papin
City
Angers cedex 02
ZIP/Postal Code
49055
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon cedex 9
ZIP/Postal Code
84918
Country
France
Facility Name
Hopital Pellegrin - Service de radiologie et d'imagerie
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Hopital Saint-Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Cabinet de radiologie Privé - Dr Joseph Mocaer
City
Brest
ZIP/Postal Code
29220
Country
France
Facility Name
Clinique Pasteur - CFRO
City
Brest
ZIP/Postal Code
29229
Country
France
Facility Name
Hopital Franco-Britannique, Institut d'Oncologie Hauts-de-Seine Nord
City
Levallois-Perret
ZIP/Postal Code
92309
Country
France
Facility Name
Institut Regional du Cancer Montpellier - Val d'Aurelle
City
Montpellier cedex 5
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital prive du Confluent S.A.S.
City
Nantes cedex 2
ZIP/Postal Code
44277
Country
France
Facility Name
Hopital prive du Confluent S.A.S
City
Nantes cedex 2
ZIP/Postal Code
44277
Country
France
Facility Name
Clinique Hartmann
City
Neuilly sur Seine
ZIP/Postal Code
92200
Country
France
Facility Name
Hopital Americain de Paris
City
Neuilly Sur Seine
ZIP/Postal Code
92200
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice cedex 2
ZIP/Postal Code
06189
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Centre Hospitalier Prive Saint Gregoire
City
Saint Gregoire
ZIP/Postal Code
35760
Country
France
Facility Name
Institut de Cancerologie de l'Ouest (ICO) - Site Rene Gauducheau
City
Saint Herblain Cedex
ZIP/Postal Code
44805
Country
France
Facility Name
Institut de cancerologie de la Loire Lucien Neuwirth
City
Saint Priest en Jarez cedex
ZIP/Postal Code
42271
Country
France
Facility Name
Centre Paul Strauss - Radiologie et medecine nucleaire
City
Strasbourg Cedex
ZIP/Postal Code
67065
Country
France
Facility Name
ICANS - Institut de cancerologie Strasbourg Europe
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Helios Klinikum Berlin-Buch, Institut fur Rontgendiagnostik
City
Berlin
State/Province
Buch
ZIP/Postal Code
13125
Country
Germany
Facility Name
Helios Klinikum Berlin-Buch, Klinik fur Nuklearmedizin
City
Berlin
State/Province
Buch
ZIP/Postal Code
13125
Country
Germany
Facility Name
Helios Klinikum Berlin-Buch, Klinik fur Strahlentherapie
City
Berlin
State/Province
Buch
ZIP/Postal Code
13125
Country
Germany
Facility Name
Helios Klinikum Berlin-Buch
City
Berlin
State/Province
Buch
ZIP/Postal Code
13125
Country
Germany
Facility Name
Universitatsklinikum Dusseldorf
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitatsklinikum Jena
City
Jena
ZIP/Postal Code
07745
Country
Germany
Facility Name
Universitatsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
General Oncology Hospital of Kifissia "Agioi Anargiroi"
City
Athens
State/Province
Attica
ZIP/Postal Code
14564
Country
Greece
Facility Name
Attikon University Hospital
City
Haidari
State/Province
Attica
ZIP/Postal Code
12462
Country
Greece
Facility Name
Euromedica General Clinic
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Facility Name
Orszagos Onkologiai Intezet, B Belgyogyaszati Osztaly
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet, Sugarterapias Osztaly
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Uzsoki Utcai Korhaz
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Koraz, Onkoradiologiai osztaly
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem, Klinikai Kozpont, Onkoterapias Intezet
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
St Luke's Radiation Oncology Network, St Luke's Hospital
City
Dublin
ZIP/Postal Code
6
Country
Ireland
Facility Name
St James's Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
St. James's Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Blackrock Clinic
City
Dublin
ZIP/Postal Code
A94 E4X7
Country
Ireland
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah University Hospital, Department of Oncology
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tiqva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
The Chaim Sheba M.C.Tel-Hashomer
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
ASST degli Spedali Civili di Brescia
City
Brescia
State/Province
BS
ZIP/Postal Code
25123
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (I.R.S.T)
City
Meldola
State/Province
FC
ZIP/Postal Code
47014
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
City
Meldola
State/Province
FC
ZIP/Postal Code
47014
Country
Italy
Facility Name
Ospedale M. Bufalini
City
Cesena
State/Province
Forlì-cesena
ZIP/Postal Code
47521
Country
Italy
Facility Name
IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
City
Meldola
State/Province
Forlì-cesena
ZIP/Postal Code
47014
Country
Italy
Facility Name
Presidio Ospedaliero Vito Fazzi
City
Lecce
State/Province
LE
ZIP/Postal Code
73100
Country
Italy
Facility Name
AOU Policlinico Di Modena
City
Modena
State/Province
MO
ZIP/Postal Code
41124
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Parma
City
Parma
State/Province
PR
ZIP/Postal Code
43126
Country
Italy
Facility Name
UOC Oncologia Medica, AUSL della Romagna -RAVENNA
City
Lugo
State/Province
RA
ZIP/Postal Code
48022
Country
Italy
Facility Name
IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
City
Ravenna
State/Province
RA
ZIP/Postal Code
48121
Country
Italy
Facility Name
UOC Oncologia Medica, AUSL della Romagna - RAVENNA
City
Ravenna
State/Province
RA
ZIP/Postal Code
48121
Country
Italy
Facility Name
AULSS 9 - Scaligera Ospedale Mater Salutis
City
Legnago
State/Province
VR
ZIP/Postal Code
37045
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS - Fondazione Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
AUSL - IRCCS and Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Name
Aichi cancer center central hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Miyagi Cancer Center
City
Natori
State/Province
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Saitama Cancer Center
City
Kita-adachi-gun
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1040045
Country
Japan
Facility Name
Cancer Institute Hospital, Japanese Foundation for Cancer Research
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Center for Proton Therapy, National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Center for Specific Organ Cancer, National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Department of Radiation Oncology, CHA Bundang Medical Center, CHA University
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun-gun
State/Province
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Division of Radiation Oncology, Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Division of Radiation Oncology, Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Department of Radiation Oncology, Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
Centrum Onkologii im. prof. F. Lukaszczyka
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Centrum Onkologii - Instytut im. M. Sklodowskiej - Curie, Klinika Radioterapii i Chemioterapii
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
SPZOZ Ministerstwa Spraw Wewnetrznych i Administracji z Warminsko-Mazurskim Centrum Onkologii
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
NZOZ Provita Prolife Centrum Medyczne
City
Tomaszow Mazowiecki
ZIP/Postal Code
97-200
Country
Poland
Facility Name
Specjalistyczny Szpital Onkologiczny NU-MED sp. z o.o.
City
Tomaszow Mazowiecki
ZIP/Postal Code
97-200
Country
Poland
Facility Name
Hospital Pedro Hispano
City
Matosinhos
State/Province
Porto
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
CUF Porto
City
Senhora da Hora
State/Province
Porto
ZIP/Postal Code
4460-188
Country
Portugal
Facility Name
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
City
Vila Nova de Gaia
State/Province
Porto
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Instituto Portugues de Oncologia de Coimbra Francisco Gentil, E.P.E.
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar do Porto, E.P.E.- Hospital de Santo Antonio
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Centro Hospitalar São João, E.P.E
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Julio Teixeira
City
Porto
ZIP/Postal Code
4460-188
Country
Portugal
Facility Name
SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
N. N. Blokhin NMRCO
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Budgetary Institution of Healthcare of Omsk Region "Clinical Oncology Dispensary"
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
FSBI "National Medical Research Center of Oncology n.a. N.N. Petrov"
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
SBIH "SPb Clinical Research Centre of Specialized Kinds of Medical Care (Oncology)"
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
SBHI YaR "Regional Clinical Oncology Hospital"
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Institut Catala d'Oncologia Badalona, Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Donostia
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital Costa del Sol
City
Marbella
State/Province
Malaga
ZIP/Postal Code
29603
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Arrixaca
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Institut Catala D'Oncologia de Girona
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Complejo Hospitalario de Jaen
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Fundacion Instituto Valenciano de Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Klinik fur Radiologie und Nuklearmedizin
City
Basel
State/Province
Basel-stadt
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Klinik fur Strahlentherapie und Radioonkologie
City
Basel
State/Province
Basel-stadt
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Universitatsspital Basel
City
Basel
State/Province
Basel-stadt
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Istituto Oncologico della Svizzera Italiana IOSI, Ospedale San Giovanni
City
Bellinzona
State/Province
Ticino
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Radiologia ORBV, Ospedale San Giovanni
City
Bellinzona
State/Province
Ticino
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Kantonsspital Winterthur, Medizinische Onkologie
City
Winterthur
State/Province
Zuerich
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
Kantonsspital Winterthur, Radiologie
City
Winterthur
State/Province
Zurich
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
Kantonsspital Winterthur
City
Winterthur
State/Province
Zurich
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
Institut fur Klinische Pathologie
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Klinik fur Nuklearmedizin
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Universitatsspital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital-Linkou Branch
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
NHS Grampian
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Trust
City
Bebington
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
University Hospital Bristol NHS Foundation Trust
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
NHS Lothian, Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Guy's and St. Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
33794205
Citation
Lee NY, Ferris RL, Psyrri A, Haddad RI, Tahara M, Bourhis J, Harrington K, Chang PM, Lin JC, Razaq MA, Teixeira MM, Lovey J, Chamois J, Rueda A, Hu C, Dunn LA, Dvorkin MV, De Beukelaer S, Pavlov D, Thurm H, Cohen E. Avelumab plus standard-of-care chemoradiotherapy versus chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):450-462. doi: 10.1016/S1470-2045(20)30737-3.
Results Reference
derived
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B9991016
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
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)
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