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Brief Title: Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)
Official Title: A Phase III, Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With and Following Chemoradiotherapy Compared to Chemoradiotherapy Alone for Treatment in Women With Locally Advanced Cervical Cancer
Study ID: NCT03830866
Brief Summary: This is a randomized, multi-center, double-blind, placebo-controlled, global, Phase III study to determine the efficacy and safety of durvalumab + Chemoradiotherapy versus Chemoradiotherapy alone as treatment in Women With Locally Advanced Cervical Cancer
Detailed Description: Women will be randomized in a 1:1 ratio to receive treatment with concurrent durvalumab + standard of care (SoC) or Placebo + Soc, followed by durvalumab/placebo maintenance for 24 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Research Site, Phoenix, Arizona, United States
Research Site, La Jolla, California, United States
Research Site, Orange, California, United States
Research Site, Fort Myers, Florida, United States
Research Site, Miami, Florida, United States
Research Site, Augusta, Georgia, United States
Research Site, Ann Arbor, Michigan, United States
Research Site, Bronx, New York, United States
Research Site, Lake Success, New York, United States
Research Site, Cleveland, Ohio, United States
Research Site, Cleveland, Ohio, United States
Research Site, Cleveland, Ohio, United States
Research Site, Nashville, Tennessee, United States
Research Site, Dallas, Texas, United States
Research Site, Dallas, Texas, United States
Research Site, Spring, Texas, United States
Research Site, Barretos, , Brazil
Research Site, Fortaleza, , Brazil
Research Site, Londrina, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Rio de Janeiro, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, São José do Rio Preto, , Brazil
Research Site, São Paulo, , Brazil
Research Site, Antofagasta, , Chile
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Temuco, , Chile
Research Site, Temuco, , Chile
Research Site, Viña del Mar, , Chile
Research Site, Changchun, , China
Research Site, Changsha, , China
Research Site, Chengdu, , China
Research Site, Chongqing, , China
Research Site, Guangzhou, , China
Research Site, Hangzhou, , China
Research Site, Hefei, , China
Research Site, Hefei, , China
Research Site, Shanghai, , China
Research Site, Shenyang, , China
Research Site, Shenyang, , China
Research Site, Tianjin, , China
Research Site, Wuhan, , China
Research Site, Wuhan, , China
Research Site, Budapest, , Hungary
Research Site, Debrecen, , Hungary
Research Site, Győr, , Hungary
Research Site, Kaposvár, , Hungary
Research Site, Szeged, , Hungary
Research Site, Ahmedabad, , India
Research Site, Gurgaon, , India
Research Site, Madurai, , India
Research Site, Mumbai, , India
Research Site, Nagpur, , India
Research Site, Nashik, , India
Research Site, New Delhi, , India
Research Site, Vishakhapatnam, , India
Research Site, Fukuoka-shi, , Japan
Research Site, Kagoshima-shi, , Japan
Research Site, Koto-ku, , Japan
Research Site, Kyoto-shi, , Japan
Research Site, Nakagami-gun, , Japan
Research Site, Osaka-shi, , Japan
Research Site, Sapporo-shi, , Japan
Research Site, Sendai-shi, , Japan
Research Site, Shinjuku-ku, , Japan
Research Site, Toon-shi, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Alc. Cuauhtémoc, , Mexico
Research Site, Deleg. Tlalpan, , Mexico
Research Site, Guadalajara Jalisco, , Mexico
Research Site, Guadalajara, , Mexico
Research Site, Mérida, , Mexico
Research Site, San Luis Potosí, , Mexico
Research Site, Veracruz, , Mexico
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Baguio City, , Philippines
Research Site, Cebu, , Philippines
Research Site, Iloilo, , Philippines
Research Site, Makati, , Philippines
Research Site, Manila, , Philippines
Research Site, Quezon City, , Philippines
Research Site, Bialystok, , Poland
Research Site, Gdańsk, , Poland
Research Site, Gliwice, , Poland
Research Site, Lublin, , Poland
Research Site, Łódź, , Poland
Research Site, Arkhangelsk, , Russian Federation
Research Site, Chelyabinsk, , Russian Federation
Research Site, Kaluga, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Novosibirsk, , Russian Federation
Research Site, Parktown, , South Africa
Research Site, Port Elizabeth, , South Africa
Research Site, Taichung, , Taiwan
Research Site, Tainan City, , Taiwan
Research Site, Taipei City, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taoyuan City, , Taiwan
Name: Urban Scheuring, M.D., Ph.D.
Affiliation: AstraZeneca
Role: STUDY_DIRECTOR
Name: Bradley Monk, M.D
Affiliation: University of Arizona, Arizona, USA
Role: PRINCIPAL_INVESTIGATOR