Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)

NCT02718417

Last updated date
Study Location
Alabama Oncology
Alabaster, Alabama, 35007, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ovarian Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically confirmed Stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component

- Patients must be candidates for platinum based chemotherapy and previously untreated

- Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy

- Availability of an archival formalin fixed, paraffin embedded (FFPE) tumor tissue block or a minimum of 15 slides

- ECOG PS 0-1

- Adequate hematological, renal, and liver function

Key

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Non epithelial tumors or ovarian tumors with low malignant potential (ie, borderline
tumors) or mucinous tumors


- Prior systemic anti-cancer treatment for EOC, FTC, or PPC including prior
immunotherapy with IL 2, IFN α, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or
anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA 4) antibody (including
ipilimumab), or any other antibody or drug specifically targeting T cell co
stimulation or immune checkpoint pathways


- Patients for whom, in the opinion of the Investigator, there is clinical benefit to
administer bevacizumab as a first-line treatment and for whom bevacizumab is approved
and available in this setting.


- Cancer for which intraperitoneal cytotoxic chemotherapy is planned


- Active autoimmune disease (some exceptions include diabetes type I, vitiligo,
psoriasis, hypo- or hyperthyroidism not requiring immunosuppressive treatment)

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Pfizer Clinical Trials Contact Center

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[email protected]

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Ovarian CancerA Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)
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  4. Roanoke, Virginia
  5. Copenhagen,
  6. Kagoshima,
  7. Cleveland, Ohio
  8. Seoul,
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  10. Poznan,
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  12. Graz,
  13. Kawasaki, Kanagawa
  14. Piacenza,
  15. Shelbyville, Tennessee
  16. Leuven,
  17. Taoyuan City,
  18. Pierre Benite cedex,
  19. Santa Barbara, California
  20. Philadelphia, Pennsylvania
  21. Seoul,
  22. Caen Cedex 5,
  23. Dublin,
  24. Velikiy Novgorod,
  25. Kernersville, North Carolina
  26. Cremona,
  27. Nottingham,
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  29. Matsuyama, Ehime
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  31. Praha 2,
  32. Nice cedex 2,
  33. Fairway, Kansas
  34. Asheville, North Carolina
  35. Krakow,
  36. London,
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  39. Prato,
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  48. Bergen,
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  50. Tucson, Arizona
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  53. Bebington, Wirral, Merseyside
  54. Dublin 7, Dublin
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  56. Sutton, Surrey
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  67. Rimini,
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  70. Olomouc,
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  72. Milwaukee, Wisconsin
  73. Chermside, Queensland
  74. Glasgow,
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  76. London,
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  105. Candiolo, Torino
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  146. Chelyabinsk,
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  148. Stockport,
  149. Edmonton, Alberta
  150. Halifax, Nova Scotia
  151. Headington, Oxford
  152. West Palm Beach, Florida
  153. Winnipeg, Manitoba
  154. South Brisbane, Queensland
  155. Halifax, Nova Scotia
  156. Silver Spring, Maryland
  157. Hermitage, Tennessee
  158. Toronto, Ontario
  159. Tsukuba, Ibaraki
  160. Hamamatsu, Shizuoka
  161. Taipei,
  162. Oslo,
  163. Luzern 16, Luzern
  164. Newcastle, New South Wales
  165. Dickson, Tennessee
  166. Gent, EAST Flanders
  167. Herston, Queensland
  168. Melbourne, Victoria
  169. Albuquerque, New Mexico
  170. Namur,
  171. Nashville, Tennessee
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  174. Dublin 4,
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  176. Praha 5,
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  179. Bebington, Wirral, Merseyside
  180. Silver Spring, Maryland
  181. Winnipeg, Manitoba
  182. Pyatigorsk, Stavropol Region
  183. Taipei City,
  184. Taipei,
  185. Hidaka, Saitama
  186. Brescia,
  187. Debrecen,
  188. Paris cedex 15,
  189. Nashville, Tennessee
  190. Nizhniy Novgorod,
  191. Nashville, Tennessee
  192. Niigata,
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  194. Louisville, Kentucky
  195. Nashville, Tennessee
  196. Kortrijk,
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  198. Kita-adachi-gun, Saitama
  199. Philadelphia, Pennsylvania
  200. Ottawa, Ontario
  201. Singapore,
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  207. Austin, Texas
  208. Montreal, Quebec
  209. Marietta, Georgia
  210. Torino,
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  214. Sutton, Surrey
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  218. Irving, Texas
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  222. Malvern, Victoria
  223. Cleveland, Ohio
  224. Budapest,
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  226. Lakewood, Colorado
  227. Singapore,
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  270. Szolnok,
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  276. Boston, Massachusetts
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  290. Akashi, Hyogo
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  2. Phoenix, Arizona
  3. Phoenix, Arizona
  4. Scottsdale, Arizona
  5. Tempe, Arizona
  6. Tucson, Arizona
  7. Tucson, Arizona
  8. Fayetteville, Arkansas
  9. Rogers, Arkansas
  10. Orange, California
  11. Santa Barbara, California
  12. Solvang, California
  13. Aurora, Colorado
  14. Boulder, Colorado
  15. Lakewood, Colorado
  16. Daytona Beach, Florida
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  18. West Palm Beach, Florida
  19. Atlanta, Georgia
  20. Atlanta, Georgia
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  22. Austell, Georgia
  23. Carrollton, Georgia
  24. Cartersville, Georgia
  25. Douglasville, Georgia
  26. Marietta, Georgia
  27. Fairway, Kansas
  28. Westwood, Kansas
  29. Louisville, Kentucky
  30. Louisville, Kentucky
  31. Louisville, Kentucky
  32. Louisville, Kentucky
  33. Louisville, Kentucky
  34. Louisville, Kentucky
  35. Louisville, Kentucky
  36. Bethesda, Maryland
  37. Columbia, Maryland
  38. Silver Spring, Maryland
  39. Silver Spring, Maryland
  40. Boston, Massachusetts
  41. Boston, Massachusetts
  42. Boston, Massachusetts
  43. Boston, Massachusetts
  44. Kansas City, Missouri
  45. Reno, Nevada
  46. Albuquerque, New Mexico
  47. Albuquerque, New Mexico
  48. Asheville, North Carolina
  49. Asheville, North Carolina
  50. Kernersville, North Carolina
  51. Winston-Salem, North Carolina
  52. Cleveland, Ohio
  53. Cleveland, Ohio
  54. Cleveland, Ohio
  55. Cleveland, Ohio
  56. Cleveland, Ohio
  57. Mayfield Heights, Ohio
  58. Mayfield Heights, Ohio
  59. Eugene, Oregon
  60. Philadelphia, Pennsylvania
  61. Philadelphia, Pennsylvania
  62. Philadelphia, Pennsylvania
  63. Dickson, Tennessee
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  65. Gallatin, Tennessee
  66. Hermitage, Tennessee
  67. Lebanon, Tennessee
  68. Murfreesboro, Tennessee
  69. Nashville, Tennessee
  70. Nashville, Tennessee
  71. Nashville, Tennessee
  72. Nashville, Tennessee
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  74. Shelbyville, Tennessee
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  76. Austin, Texas
  77. Austin, Texas
  78. Bedford, Texas
  79. Fort Worth, Texas
  80. Irving, Texas
  81. Irving, Texas
  82. San Antonio, Texas
  83. The Woodlands, Texas
  84. Salt Lake City, Utah
  85. Roanoke, Virginia
  86. Roanoke, Virginia
  87. Milwaukee, Wisconsin
  88. Milwaukee, Wisconsin
  89. New Lambton Heights, New South Wales
  90. Newcastle, New South Wales
  91. Auchenflower, Queensland
  92. Auchenflower, Queensland
  93. Brisbane, Queensland
  94. Chermside, Queensland
  95. Herston, Queensland
  96. Herston, Queensland
  97. Herston, Queensland
  98. South Brisbane, Queensland
  99. South Brisbane, Queensland
  100. South Brisbane, Queensland
  101. Southport, Queensland
  102. Brighton, Victoria
  103. Malvern, Victoria
  104. Melbourne, Victoria
  105. Parkville, Victoria
  106. Parkville, Victoria
  107. Parkville, Victoria
  108. Graz,
  109. Innsbruck,
  110. Gent, EAST Flanders
  111. Brussels,
  112. Kortrijk,
  113. Leuven,
  114. Liege,
  115. Namur,
  116. Calgary, Alberta
  117. Edmonton, Alberta
  118. Kelowna, British Columbia
  119. Vancouver, British Columbia
  120. Winnipeg, Manitoba
  121. Winnipeg, Manitoba
  122. Winnipeg, Manitoba
  123. Halifax, Nova Scotia
  124. Halifax, Nova Scotia
  125. Ottawa, Ontario
  126. Toronto, Ontario
  127. Toronto, Ontario
  128. Montreal, Quebec
  129. Montreal, Quebec
  130. Montreal, Quebec
  131. Praha 2, Czech Republic
  132. Olomouc,
  133. Ostrava-Poruba,
  134. Praha 2,
  135. Praha 2,
  136. Praha 2,
  137. Praha 5,
  138. Usti nad Labem,
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  140. Copenhagen,
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  144. Paris cedex 15,
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  147. Vandoeuvre-lès-Nancy,
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  150. Athens,
  151. Hong Kong,
  152. Hong Kong,
  153. Budapest,
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  155. Debrecen,
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  159. Dublin 7, Dublin
  160. Dublin 4,
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  165. Waterford,
  166. Jerusalem,
  167. Manerbio, Brescia
  168. Costa Masnaga, Lecco
  169. Miano, Milano
  170. Lugo, Ravenna
  171. Candiolo, Torino
  172. Bergamo,
  173. Bergamo,
  174. Bergamo,
  175. Brescia,
  176. Como,
  177. Cremona,
  178. Cremona,
  179. Cremona,
  180. Milano,
  181. Piacenza,
  182. Piacenza,
  183. Prato,
  184. Prato,
  185. Rimini,
  186. Torino,
  187. Matsuyama, Ehime
  188. Toon, Ehime
  189. Sapporo, Hokkaido
  190. Akashi, Hyogo
  191. Tsukuba, Ibaraki
  192. Isehara, Kanagawa
  193. Kawasaki, Kanagawa
  194. Yokohama, Kanagawa
  195. Sendai, Miyagi
  196. Hidaka, Saitama
  197. Kita-adachi-gun, Saitama
  198. Tokorozawa, Saitama
  199. Hamamatsu, Shizuoka
  200. Shimotsuke, Tochigi
  201. Bunkyo-ku, Tokyo
  202. Chuo-ku, Tokyo
  203. Kagoshima,
  204. Kagoshima,
  205. Niigata,
  206. Goyangsi, Gyeonggi-do
  207. Daegu,
  208. Daegu,
  209. Seoul,
  210. Seoul,
  211. Seoul,
  212. Seoul,
  213. Seoul,
  214. Seoul,
  215. Seoul,
  216. Seoul,
  217. Seoul,
  218. Seoul,
  219. Seoul,
  220. Groningen,
  221. Groningen,
  222. Leiden,
  223. Maastricht,
  224. Bergen,
  225. Bergen,
  226. Oslo,
  227. Oslo,
  228. Krakow,
  229. Krakow,
  230. Olsztyn,
  231. Olsztyn,
  232. Poznan,
  233. Poznan,
  234. Rybnik,
  235. Rybnik,
  236. Sochi, Krasnodar Region
  237. Pyatigorsk, Stavropol Region
  238. Chelyabinsk,
  239. Chelyabinsk,
  240. Krasnodar,
  241. Moscow,
  242. Nizhniy Novgorod,
  243. Orenburg,
  244. Saint Petersburg,
  245. Velikiy Novgorod,
  246. Singapore,
  247. Singapore,
  248. Singapore,
  249. Singapore,
  250. Singapore,
  251. L'Hospitalet de Llobregat, Barcelona
  252. Cordoba,
  253. Girona,
  254. Madrid,
  255. Madrid,
  256. Madrid,
  257. Sevilla,
  258. Basel, Basel-stadt
  259. Basel, Basel-stadt
  260. Luzern 16, Luzern
  261. Bellinzona, Ticino
  262. Zurich,
  263. Zurich,
  264. Zurich,
  265. Zurich,
  266. Zurich,
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  268. Tainan City,
  269. Taipei city,
  270. Taipei City,
  271. Taipei City,
  272. Taipei City,
  273. Taipei City,
  274. Taipei,
  275. Taipei,
  276. Taipei,
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  278. Taoyuan City,
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  280. Glasgow, CITY OF Glasgow
  281. Bebington, Wirral, Merseyside
  282. Bebington, Wirral, Merseyside
  283. Northwood, Middlesex
  284. Northampton, Northamptonshire
  285. Headington, Oxford
  286. Sutton, Surrey
  287. Sutton, Surrey
  288. Glasgow,
  289. London,
  290. London,
  291. London,
  292. London,
  293. London,
  294. London,
  295. Manchester,
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  297. Nottingham,
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  3. Szolnok,
  4. Bratislava,
  5. Kyiv,
  6. Alabaster, Alabama
  7. Bessemer, Alabama
  8. Birmingham, Alabama
  9. Birmingham, Alabama
  10. Birmingham, Alabama
  11. Birmingham, Alabama
  12. Birmingham, Alabama
  13. Phoenix, Arizona
  14. Phoenix, Arizona
  15. Scottsdale, Arizona
  16. Tempe, Arizona
  17. Tucson, Arizona
  18. Fayetteville, Arkansas
  19. Rogers, Arkansas
  20. Irvine, California
  21. Newport Beach, California
  22. San Francisco, California
  23. San Francisco, California
  24. San Francisco, California
  25. San Francisco, California
  26. San Francisco, California
  27. San Francisco, California
  28. Santa Barbara, California
  29. New Haven, Connecticut
  30. Miami, Florida
  31. Miami, Florida
  32. Atlanta, Georgia
  33. Atlanta, Georgia
  34. Atlanta, Georgia
  35. Atlanta, Georgia
  36. Atlanta, Georgia
  37. Arlington Heights, Illinois
  38. Baltimore, Maryland
  39. Baltimore, Maryland
  40. Baltimore, Maryland
  41. Newark, New Jersey
  42. Newark, New Jersey
  43. Newark, New Jersey
  44. Newark, New Jersey
  45. Bronx, New York
  46. Bronx, New York
  47. Bronx, New York
  48. Bronx, New York
  49. Mineola, New York
  50. Mineola, New York
  51. Mineola, New York
  52. Mineola, New York
  53. Mineola, New York
  54. Cincinnati, Ohio
  55. Portland, Oregon
  56. Portland, Oregon
  57. Portland, Oregon
  58. Tualatin, Oregon
  59. Dickson, Tennessee
  60. Franklin, Tennessee
  61. Gallatin, Tennessee
  62. Hermitage, Tennessee
  63. Lebanon, Tennessee
  64. Murfreesboro, Tennessee
  65. Nashville, Tennessee
  66. Nashville, Tennessee
  67. Nashville, Tennessee
  68. Nashville, Tennessee
  69. Nashville, Tennessee
  70. Shelbyville, Tennessee
  71. Smyrna, Tennessee
  72. Bedford, Texas
  73. Fort Worth, Texas
  74. Irving, Texas
  75. Irving, Texas
  76. Irving, Texas
  77. San Antonio, Texas
  78. Tyler, Texas
  79. Norfolk, Virginia
  80. Vancouver, Washington
  81. Auchenflower, Queensland
  82. Chermside, Queensland
  83. South Brisbane, Queensland
  84. Southport, Queensland
  85. Brighton, Victoria
  86. East Melbourne, Victoria
  87. Malvern, Victoria
  88. Malvern, Victoria
  89. Malvern, Victoria
  90. Richmond, Victoria
  91. Richmond, Victoria
  92. Charleroi,
  93. Namur,
  94. Split,
  95. Tallinn,
  96. Tallinn,
  97. Tartu,
  98. Budapest,
  99. Budapest,
  100. Debrecen,
  101. Debrecen,
  102. Miskolc,
  103. Cork,
  104. Milano, MI
  105. Roma, RM
  106. Sondrio, SO
  107. Sondrio, SO
  108. Kashiwa, Chiba
  109. Toon, Ehime
  110. Kure, Hiroshima
  111. Sapporo, Hokkaido
  112. Akashi, Hyogo
  113. Kawasaki, Kanagawa
  114. Yokohama, Kanagawa
  115. Hidaka, Saitama
  116. Chuo-ku, Tokyo
  117. Hiroshima,
  118. Niigata,
  119. Gyeonggi-do,
  120. Seoul,
  121. Seoul,
  122. Seoul,
  123. Seoul,
  124. Seoul,
  125. Seoul,
  126. Seoul,
  127. Seoul,
  128. Seoul,
  129. Seoul,
  130. Seoul,
  131. Grudziądz,
  132. Obninsk, Kaluga Region
  133. Sochi, Krasnodarskiy Region
  134. Orenburg, Orenburg Region
  135. Pyatigorsk, Stavropol KRAI
  136. Chelyabinsk,
  137. Ivanovo,
  138. Moscow,
  139. Moscow,
  140. Saint-Petersburg,
  141. Singapore,
  142. Singapore,
  143. Singapore,
  144. Singapore,
  145. Singapore,
  146. Singapore,
  147. Singapore,
  148. Singapore,
  149. Singapore,
  150. Bardejov,
  151. Poprad,
  152. New Taipei city,
  153. New Taipei City,
  154. New Taipei City,
  155. Taipei City,
  156. Taipei,
  157. Taipei,
  158. Taipei,
  159. Taipei,
Female
18 Years+
years
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Advanced Information
Descriptive Information
Brief Title  ICMJE Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)
Official Title  ICMJE A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AND/OR FOLLOWING CHEMOTHERAPY IN PATIENTS WITH PREVIOUSLY UNTREATED EPITHELIAL OVARIAN CANCER JAVELIN OVARIAN 100
Brief Summary

This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for platinum-based chemotherapy.

The primary purpose of the study is to demonstrate if avelumab given as single agent in the maintenance setting following frontline chemotherapy or in combination with carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by observation in this population of newly diagnosed ovarian cancer patients.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: carboplatin
    Given Q3W during chemotherapy phase
  • Drug: paclitaxel
    Investigator choice of weekly or Q3W during chemotherapy phase
  • Drug: Avelumab
    Given Q3W in combination with carboplatin/paclitaxel during chemotherapy portion
  • Drug: Avelumab
    Given as single agent in maintenance portion Q2W
Study Arms  ICMJE
  • Active Comparator: Arm A
    Chemotherapy followed by observation
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
  • Experimental: Arm B
    Chemotherapy followed by avelumab in maintenance
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
    • Drug: Avelumab
  • Experimental: Arm C
    Chemotherapy in combination with avelumab followed by avelumab in maintenance
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
    • Drug: Avelumab
    • Drug: Avelumab
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: July 29, 2019)
998
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2016)
951
Actual Study Completion Date  ICMJE May 16, 2019
Actual Primary Completion Date September 7, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Histologically confirmed Stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component
  • Patients must be candidates for platinum based chemotherapy and previously untreated
  • Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy
  • Availability of an archival formalin fixed, paraffin embedded (FFPE) tumor tissue block or a minimum of 15 slides
  • ECOG PS 0-1
  • Adequate hematological, renal, and liver function

Key Exclusion Criteria:

  • Non epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors
  • Prior systemic anti-cancer treatment for EOC, FTC, or PPC including prior immunotherapy with IL 2, IFN ?, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways
  • Patients for whom, in the opinion of the Investigator, there is clinical benefit to administer bevacizumab as a first-line treatment and for whom bevacizumab is approved and available in this setting.
  • Cancer for which intraperitoneal cytotoxic chemotherapy is planned
  • Active autoimmune disease (some exceptions include diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroidism not requiring immunosuppressive treatment)
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
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 Bulgaria,   Canada,   Croatia,   Estonia,   Germany,   Hong Kong,   Hungary,   Ireland,   Italy,   Japan,   Korea, Republic of,   Latvia,   Mexico,   Netherlands,   Poland,   Romania,   Russian Federation,   Singapore,   Slovakia,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02718417
Other Study ID Numbers  ICMJE B9991010
2015-003239-36 ( EudraCT Number )
JAVELIN OVARIAN 100 ( 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
Study Chair:Bradley Monk, MDDepartment of Obstetrics and Gynecology University of Arizona Cancer Center, USA
Study Chair:Jonathan Ledermann, MDUCL Cancer Institute, UK
PRS Account Pfizer
Verification Date June 2020

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