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)

NCT02952586

Last updated date
Study Location
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Squamous Cell Carcinoma of the Head and Neck
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years

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Squamous Cell Carcinoma of the Head and NeckStudy 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)
NCT02952586
  1. Fayetteville, Arkansas
  2. Rogers, Arkansas
  3. Anaheim, California
  4. Bakersfield, California
  5. Beverly Hills, California
  6. Beverly Hills, California
  7. Chula Vista, California
  8. Corona, California
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  21. Orange, California
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  25. South Pasadena, California
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  29. Aurora, Colorado
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  34. Denver, Colorado
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  36. Parker, Colorado
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  49. Tinley Park, Illinois
  50. Lafayette, Indiana
  51. Overland Park, Kansas
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  53. Louisville, Kentucky
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  58. Prestonsburg, Kentucky
  59. Baltimore, Maryland
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  62. Boston, Massachusetts
  63. Detroit, Michigan
  64. Detroit, Michigan
  65. Farmington Hills, Michigan
  66. Lansing, Michigan
  67. Corinth, Mississippi
  68. Columbia, Missouri
  69. Creve Coeur, Missouri
  70. Kansas City, Missouri
  71. Saint Louis, Missouri
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  73. Saint Louis, Missouri
  74. Saint Peters, Missouri
  75. Omaha, Nebraska
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  77. Basking Ridge, New Jersey
  78. Hackensack, New Jersey
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  112. Pittsburgh, Pennsylvania
  113. Pittsburgh, Pennsylvania
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  115. Charleston, South Carolina
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  117. Charleston, South Carolina
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  119. Charleston, South Carolina
  120. Easley, South Carolina
  121. Greenville, South Carolina
  122. Greenville, South Carolina
  123. Greer, South Carolina
  124. Seneca, South Carolina
  125. Spartanburg, South Carolina
  126. Germantown, Tennessee
  127. Memphis, Tennessee
  128. Nashville, Tennessee
  129. El Paso, Texas
  130. El Paso, Texas
  131. El Paso, Texas
  132. Galveston, Texas
  133. Houston, Texas
  134. Houston, Texas
  135. League City, Texas
  136. Murray, Utah
  137. Salt Lake City, Utah
  138. Seattle, Washington
  139. Seattle, Washington
  140. Camperdown, New South Wales
  141. Camperdown, New South Wales
  142. Camperdown, New South Wales
  143. St Leonards, New South Wales
  144. Wollongong, New South Wales
  145. Geelong, Victoria
  146. Heidelberg, Victoria
  147. Linz,
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  150. Haine Saint Paul,
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  154. Beijing, Beijing
  155. Fuzhou, Fujian
  156. Guangzhou, Guangdong
  157. Guangzhou, Guangdong
  158. Nanning, Guangxi
  159. Haikou, Hainan
  160. Zhengzhou, Henan
  161. Wuhan, Hubei
  162. Wuhan, Hubei
  163. Changsha, Hunan
  164. Shenyang, Liaoning
  165. Shanghai, Shanghai
  166. Shanghai, Shanghai
  167. Chengdu, Sichuan
  168. Tianjin, Tianjin
  169. Haerbin,
  170. Angers cedex 02,
  171. Avignon cedex 9,
  172. Bordeaux CEDEX,
  173. Bordeaux,
  174. Bordeaux,
  175. Brest,
  176. Brest,
  177. Levallois-Perret,
  178. Montpellier cedex 5,
  179. Nantes cedex 2,
  180. Nantes cedex 2,
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  182. Neuilly Sur Seine,
  183. Nice cedex 2,
  184. Paris,
  185. Pessac,
  186. Saint Gregoire,
  187. Saint Priest en Jarez cedex,
  188. Saint-Herblain cedex,
  189. Strasbourg Cedex,
  190. Villejuif,
  191. Berlin, Buch
  192. Berlin, Buch
  193. Berlin, Buch
  194. Berlin, Buch
  195. Dusseldorf,
  196. Jena,
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  198. Regensburg,
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  200. Haidari, Attica
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  222. Lecce, LE
  223. Modena, MO
  224. Parma, PR
  225. Lugo, RA
  226. Ravenna, RA
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  228. Legnago, VR
  229. Napoli,
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  232. Nagoya, Aichi
  233. Kashiwa, Chiba
  234. Matsuyama, Ehime
  235. Sapporo, Hokkaido
  236. Kobe, Hyogo
  237. Natori, Miyagi
  238. Sendai, Miyagi
  239. Osaka-shi, Osaka
  240. Osakasayama, Osaka
  241. Kita-adachi-gun, Saitama
  242. Sunto-gun, Shizuoka
  243. Shimotsuke, Tochigi
  244. Chuo-ku, Tokyo
  245. Koto-ku, Tokyo
  246. Goyang-si, Gyeonggi-do
  247. Goyang-si, Gyeonggi-do
  248. Seongnam-si, Gyeonggi-do
  249. Seongnam-si, Gyeonggi-do
  250. Hwasun-gun, Jeollanam-do
  251. Seoul,
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  267. Vila Nova de Gaia, Porto
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  280. San Sebastian, Guipuzcoa
  281. Marbella, Malaga
  282. El Palmar, Murcia
  283. Barcelona,
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  296. Basel, Basel-stadt
  297. Basel, Basel-stadt
  298. Bellinzona, Ticino
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  300. Lausanne, Vaud
  301. Winterthur, Zuerich
  302. Winterthur, Zurich
  303. Winterthur, Zurich
  304. Zurich,
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  307. Taichung,
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  318. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma of the Head and Neck
Intervention  ICMJE
  • Drug: Avelumab
    Avelumab + SOC Chemoradiation
  • Other: Chemoradiation
    Cisplatin + Radiation Therapy
Study Arms  ICMJE
  • Experimental: Avelumab + SOC Chemoradiation Therapy
    • Avelumab 10 mg/kg IV: Day 1 of the Lead-in Phase; Days 8, 25, and 39 of the CRT Phase; and Q2W for 12 months during the Maintenance Phase
    • Cisplatin 100 mg/m2 IV: Days 1, 22, and 43 of the CRT Phase
    • Intensity Modulated Radiation Therapy (IMRT) 70 Gy/35 fractions/7 weeks; 1 fraction per day, 5 fractions/week for 7 weeks during the CRT Phase
    Intervention: Drug: Avelumab
  • Placebo Comparator: Placebo + SOC CRT
    • Placebo IV matching avelumab: Days 1 of the Lead-in Phase; Days 8, 25, and 39 of the CRT Phase; Q2W for 12 months during the Maintenance Phase
    • Cisplatin 100 mg/m2 IV: Days 1, 22, and 43 of the CRT Phase
    • IMRT 70 Gy/35 fractions/7 weeks; 1 fraction per day, 5 fractions/week for 7 weeks during the CRT Phase
    Intervention: Other: Chemoradiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 30, 2019)
697
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2016)
640
Actual Study Completion Date  ICMJE June 19, 2020
Actual Primary Completion Date December 23, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   China,   France,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Poland,   Portugal,   Russian Federation,   Spain,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02952586
Other Study ID Numbers  ICMJE B9991016
2016-001456-21 ( EudraCT Number )
LOCALLY ADVANCED HEAD AND NECK ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP