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Brief Title: Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer
Official Title: A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)
Study ID: NCT04269200
Brief Summary: A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.
Detailed Description: This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer. Target patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Research Site, Tucson, Arizona, United States
Research Site, Concord, California, United States
Research Site, La Jolla, California, United States
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Research Site, Honolulu, Hawaii, United States
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Research Site, Bedford, Texas, United States
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Research Site, Morgantown, West Virginia, United States
Research Site, Madison, Wisconsin, United States
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Research Site, Clayton, , Australia
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Research Site, Libramont-Chevigny, , Belgium
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Research Site, Belo Horizonte, , Brazil
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Research Site, Calgary, Alberta, Canada
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Research Site, Sunto-gun, , Japan
Research Site, Toon-Shi, , Japan
Research Site, Tsu-shi, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Goyang-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
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Research Site, Suwon, , Korea, Republic of
Research Site, Yangsan-si, , Korea, Republic of
Research Site, Kaunas, , Lithuania
Research Site, Vilnius, , Lithuania
Research Site, Vilnius, , Lithuania
Research Site, Aguascalientes, , Mexico
Research Site, Mexico, , Mexico
Research Site, Monterrey, , Mexico
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Research Site, Veracruz, , Mexico
Research Site, Gdansk, , Poland
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Research Site, Anzorey, , Russian Federation
Research Site, Kazan, Tatarstan, , Russian Federation
Research Site, Krasnodar, , Russian Federation
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Name: Shannon N. Westin, MD, MPH, FACOG
Affiliation: The University of Texas MD Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR