A 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)

NCT02580058

Last updated date
Study Location
Arizona Oncology Associates, PC - HAL
Chandler, Arizona, 85224, 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.
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 epithelial ovarian, fallopian tube, or peritoneal cancer.

- Platinum resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively.

- Received up to 3 lines of chemotherapy for platinum sensitive disease, most recently platinum containing, and no prior therapy for platinum resistant disease.

- Measurable disease by investigator assessment with at least 1 unidimensional measurable lesion by RECIST v.1.1 that has not previously been irradiated.

- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible.

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


- Non epithelial tumor, including malignant mixed Müllerian tumors without high grade
serous component, or ovarian tumors with low malignant potential (ie, borderline
tumors).


- Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti
cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab,
tremelimumab or any other antibody or drug specifically targeting T cell co
stimulation or immune checkpoint pathways).


- Known symptomatic brain metastases requiring steroids. Patients with previously
diagnosed brain metastases are eligible if they have completed their treatment and
have recovered from the acute effects of radiation therapy or surgery prior to study
entry, have discontinued corticosteroid treatment for these metastases for at least 4
weeks prior to study entry and are neurologically stable.


- Diagnosis of any other malignancy within 5 years prior to registration, except for
adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of
the breast or of the cervix.


- Severe gastrointestinal conditions such as clinical or radiological evidence of bowel
obstruction within 4 weeks prior to study entry, uncontrolled diarrhea in the last 4
weeks prior to enrollment, or history of inflammatory bowel disease.

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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) NCT02580058
  1. The Woodlands, Texas
  2. Costa Masnaga, Lecco
  3. Tainan City,
  4. Roanoke, Virginia
  5. Copenhagen,
  6. Kagoshima,
  7. Cleveland, Ohio
  8. Seoul,
  9. Orange, California
  10. Poznan,
  11. Bedford, Texas
  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,
  28. Calgary, Alberta
  29. Matsuyama, Ehime
  30. Louisville, Kentucky
  31. Praha 2,
  32. Nice cedex 2,
  33. Fairway, Kansas
  34. Asheville, North Carolina
  35. Krakow,
  36. London,
  37. Oslo,
  38. Boston, Massachusetts
  39. Prato,
  40. Singapore,
  41. Wellington, Florida
  42. Innsbruck,
  43. Rogers, Arkansas
  44. Seoul,
  45. Nottingham,
  46. Rybnik,
  47. Brisbane, Queensland
  48. Bergen,
  49. Brussels,
  50. Tucson, Arizona
  51. Bergamo,
  52. Mayfield Heights, Ohio
  53. Bebington, Wirral, Merseyside
  54. Dublin 7, Dublin
  55. Scottsdale, Arizona
  56. Sutton, Surrey
  57. Moscow,
  58. Praha 2,
  59. Austin, Texas
  60. Atlanta, Georgia
  61. Seoul,
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  64. Boulder, Colorado
  65. Cremona,
  66. Winston-Salem, North Carolina
  67. Rimini,
  68. Lugo, Ravenna
  69. Montreal, Quebec
  70. Olomouc,
  71. Phoenix, Arizona
  72. Milwaukee, Wisconsin
  73. Chermside, Queensland
  74. Glasgow,
  75. Tucson, Arizona
  76. London,
  77. Zurich,
  78. Waterford,
  79. Fort Worth, Texas
  80. London,
  81. Irving, Texas
  82. Bellinzona, Ticino
  83. London,
  84. Chuo-ku, Tokyo
  85. Goyangsi, Gyeonggi-do
  86. Cordoba,
  87. Murfreesboro, Tennessee
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  89. Madrid,
  90. Lyon cedex 08,
  91. Cleveland, Ohio
  92. Parkville, Victoria
  93. New Lambton Heights, New South Wales
  94. Miano, Milano
  95. Basel, Basel-stadt
  96. Isehara, Kanagawa
  97. Winnipeg, Manitoba
  98. Seoul,
  99. Auchenflower, Queensland
  100. Seoul,
  101. Atlanta, Georgia
  102. Milwaukee, Wisconsin
  103. Gallatin, Tennessee
  104. Mayfield Heights, Ohio
  105. Candiolo, Torino
  106. Philadelphia, Pennsylvania
  107. Daytona Beach, Florida
  108. Cleveland, Ohio
  109. Praha 2, Czech Republic
  110. Dublin,
  111. Parkville, Victoria
  112. Taipei City,
  113. Bethesda, Maryland
  114. Northwood, Middlesex
  115. Herston, Queensland
  116. Bunkyo-ku, Tokyo
  117. Taipei,
  118. Manerbio, Brescia
  119. Zurich,
  120. Yokohama, Kanagawa
  121. Boston, Massachusetts
  122. Girona,
  123. Vandoeuvre-lès-Nancy,
  124. London,
  125. Dublin 4,
  126. Taoyuan City,
  127. L'Hospitalet de Llobregat, Barcelona
  128. Seoul,
  129. Aurora, Colorado
  130. Asheville, North Carolina
  131. Prato,
  132. Boston, Massachusetts
  133. Kelowna, British Columbia
  134. Parkville, Victoria
  135. Louisville, Kentucky
  136. Madrid,
  137. Douglasville, Georgia
  138. Glasgow, CITY OF Glasgow
  139. Cartersville, Georgia
  140. Krakow,
  141. Singapore,
  142. Daegu,
  143. Taipei City,
  144. Westwood, Kansas
  145. Toronto, Ontario
  146. Chelyabinsk,
  147. Austell, Georgia
  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
  172. Taipei city,
  173. London,
  174. Dublin 4,
  175. Piacenza,
  176. Praha 5,
  177. Zurich,
  178. Fayetteville, Arkansas
  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,
  193. Louisville, Kentucky
  194. Louisville, Kentucky
  195. Nashville, Tennessee
  196. Kortrijk,
  197. Phoenix, Arizona
  198. Kita-adachi-gun, Saitama
  199. Philadelphia, Pennsylvania
  200. Ottawa, Ontario
  201. Singapore,
  202. Maastricht,
  203. Chelyabinsk,
  204. Praha 2,
  205. Aalborg,
  206. Roanoke, Virginia
  207. Austin, Texas
  208. Montreal, Quebec
  209. Marietta, Georgia
  210. Torino,
  211. Milano,
  212. Dublin,
  213. Franklin, Tennessee
  214. Sutton, Surrey
  215. Poznan,
  216. Dublin 7, Dublin
  217. Sapporo, Hokkaido
  218. Irving, Texas
  219. Southport, Queensland
  220. Hong Kong,
  221. Ostrava-Poruba,
  222. Malvern, Victoria
  223. Cleveland, Ohio
  224. Budapest,
  225. Manchester,
  226. Lakewood, Colorado
  227. Singapore,
  228. Groningen,
  229. Lebanon, Tennessee
  230. Smyrna, Tennessee
  231. Paris,
  232. Rybnik,
  233. Seoul,
  234. Reno, Nevada
  235. Nashville, Tennessee
  236. Zurich,
  237. South Brisbane, Queensland
  238. Athens/New Kifissia,
  239. Debrecen,
  240. Chandler, Arizona
  241. Krasnodar,
  242. Tainan city,
  243. Atlanta, Georgia
  244. Auchenflower, Queensland
  245. Kagoshima,
  246. Liege,
  247. Cleveland, Ohio
  248. Groningen,
  249. Herston, Queensland
  250. Jerusalem,
  251. Tempe, Arizona
  252. Sochi, Krasnodar Region
  253. Seoul,
  254. San Antonio, Texas
  255. Usti nad Labem,
  256. Olsztyn,
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  258. Brighton, Victoria
  259. Orenburg,
  260. Seoul,
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  262. Salt Lake City, Utah
  263. Cambridge, Cambridgeshire
  264. Tokorozawa, Saitama
  265. Cremona,
  266. Seoul,
  267. Bergen,
  268. Solvang, California
  269. Montreal, Quebec
  270. Szolnok,
  271. Bergamo,
  272. Albuquerque, New Mexico
  273. Northampton, Northamptonshire
  274. Bergamo,
  275. South Brisbane, Queensland
  276. Boston, Massachusetts
  277. Taipei City,
  278. Olsztyn,
  279. Madrid,
  280. Zurich,
  281. Columbia, Maryland
  282. Vancouver, British Columbia
  283. Daegu,
  284. Shimotsuke, Tochigi
  285. Basel, Basel-stadt
  286. Athens,
  287. Eugene, Oregon
  288. Hong Kong,
  289. Villejuif cedex,
  290. Akashi, Hyogo
  291. Carrollton, Georgia
  292. Louisville, Kentucky
  293. Budapest,
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  295. Singapore,
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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) NCT02580058
  1. Chandler, Arizona
  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
  17. Wellington, Florida
  18. West Palm Beach, Florida
  19. Atlanta, Georgia
  20. Atlanta, Georgia
  21. Atlanta, Georgia
  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
  64. Franklin, Tennessee
  65. Gallatin, Tennessee
  66. Hermitage, Tennessee
  67. Lebanon, Tennessee
  68. Murfreesboro, Tennessee
  69. Nashville, Tennessee
  70. Nashville, Tennessee
  71. Nashville, Tennessee
  72. Nashville, Tennessee
  73. Nashville, Tennessee
  74. Shelbyville, Tennessee
  75. Smyrna, Tennessee
  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,
  139. Aalborg,
  140. Copenhagen,
  141. Caen Cedex 5,
  142. Lyon cedex 08,
  143. Nice cedex 2,
  144. Paris cedex 15,
  145. Paris,
  146. Pierre Benite cedex,
  147. Vandoeuvre-lès-Nancy,
  148. Villejuif cedex,
  149. Athens/New Kifissia,
  150. Athens,
  151. Hong Kong,
  152. Hong Kong,
  153. Budapest,
  154. Budapest,
  155. Debrecen,
  156. Debrecen,
  157. Szolnok,
  158. Dublin 7, Dublin
  159. Dublin 7, Dublin
  160. Dublin 4,
  161. Dublin 4,
  162. Dublin,
  163. Dublin,
  164. Dublin,
  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,
  267. Tainan city,
  268. Tainan City,
  269. Taipei city,
  270. Taipei City,
  271. Taipei City,
  272. Taipei City,
  273. Taipei City,
  274. Taipei,
  275. Taipei,
  276. Taipei,
  277. Taoyuan City,
  278. Taoyuan City,
  279. Cambridge, Cambridgeshire
  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,
  296. Nottingham,
  297. Nottingham,
  298. Stockport,
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Ovarian CancerAvelumab and Talazoparib in Untreated Advanced Ovarian Cancer (JAVELIN OVARIAN PARP 100) NCT03642132
  1. Danbury, Connecticut
  2. Norwalk, Connecticut
  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
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A 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)
Official Title  ICMJE A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF AVELUMAB (MSB0010718C) ALONE OR IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS PEGYLATED LIPOSOMAL DOXORUBICIN ALONE IN PATIENTS WITH PLATINUM-RESISTANT/REFRACTORY OVARIAN CANCER
Brief Summary A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.
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
  • Biological: avelumab
    10 mg/kg will be given as a 1 hour intravenous infusion (IV) every 2 weeks (Q2W) in 4 week cycles
  • Drug: PLD
    PLD (Arm B, Arm C) 40 mg/m2 will be given as a 1 hour IV infusion every 4 weeks (Q4W) in 4 week cycles
    Other Name: doxorubicin, caelyx
Study Arms  ICMJE
  • Experimental: avelumab
    Arm A: avelumab alone
    Intervention: Biological: avelumab
  • Experimental: avelumab plus pegylated liposomal doxorubicin (PLD)
    Arm B: avelumab plus PLD
    Interventions:
    • Biological: avelumab
    • Drug: PLD
  • Active Comparator: PLD
    Arm C: PLD alone
    Intervention: Drug: PLD
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 3, 2018)
566
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2015)
550
Estimated Study Completion Date  ICMJE December 18, 2019
Actual Primary Completion Date September 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component.
  • Platinum resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively.
  • Received up to 3 lines of systemic anticancer therapy for platinum sensitive disease, most recently platinum containing, and no prior systemic therapy for platinum resistant disease
  • Measurable disease by investigator assessment with at least 1 unidimensional measurable lesion by RECIST v.1.1 that has not previously been irradiated
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible.

Mandatory tumor biopsy must be performed prior to enrollment for all patients (unless there is a documented clinical contraindication). In addition, availability of archived FFPE tumor tissue should be confirmed. If a patient underwent tumor tissue collection within 3 months prior to enrollment with no intervening treatment, and the sample is provided, then a new de novo tumor biopsy is not required.

Exclusion Criteria:

  • Non epithelial tumor or ovarian tumors with low malignant potential (ie, borderline tumors).
  • Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab, tremelimumab or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways).
  • Known symptomatic brain metastases requiring steroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks prior to study entry and are neurologically stable.
  • Diagnosis of any other malignancy within 5 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.
  • Severe gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction within 4 weeks prior to study entry, uncontrolled diarrhea in the last 4 weeks prior to enrollment, or history of inflammatory bowel disease.
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 Australia,   Austria,   Belgium,   Canada,   Czechia,   Denmark,   France,   Greece,   Hong Kong,   Hungary,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Norway,   Poland,   Russian Federation,   Singapore,   Spain,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02580058
Other Study ID Numbers  ICMJE B9991009
2015-003091-77 ( EudraCT Number )
JAVELIN OVARIAN 200 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Not Provided
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 October 2019

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