Spots Global Cancer Trial Database for A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)
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Trial Identification
Brief Title: A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)
Official Title: A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Platinum-Ineligible Patients With Unresectable Stage IV Urothelial Cancer
Study ID: NCT03459846
Conditions
Study Description
Brief Summary: A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Platinum-Ineligible Patients With Unresectable Stage IV Urothelial Cancer
Detailed Description: This is a Phase II, randomized, double-blind, placebo controlled, multi-center, comparative global study to determine the efficacy and safety of durvalumab + olaparib combination therapy versus durvalumab + placebo (durvalumab monotherapy) as first-line treatment in patients ineligible for platinum-based chemotherapy with unresectable Stage IV urothelial cancer (UC).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Birmingham, Alabama, United States
Research Site, Goodyear, Arizona, United States
Research Site, Fort Myers, Florida, United States
Research Site, Saint Petersburg, Florida, United States
Research Site, Tampa, Florida, United States
Research Site, Louisville, Kentucky, United States
Research Site, Bronx, New York, United States
Research Site, New Hyde Park, New York, United States
Research Site, New York, New York, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Nashville, Tennessee, United States
Research Site, Tacoma, Washington, United States
Research Site, Hamilton, Ontario, Canada
Research Site, Newmarket, Ontario, Canada
Research Site, Sudbury, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Incheon, , 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
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Novosibirsk, , Russian Federation
Research Site, Omsk, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, St. Petersburg, , Russian Federation
Research Site, St. Petersburg, , Russian Federation
Research Site, Barcelona, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Málaga, , Spain
Research Site, Santiago de Compostela, , Spain
Research Site, Kaohsiung, , Taiwan
Research Site, Kaohsiung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Tainan, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taoyuan City, , Taiwan
Research Site, Hanoi, , Vietnam
Research Site, Ho Chi Minh city, , Vietnam
Research Site, Ho Chi Minh, , Vietnam
Contact Details
Name: Jonathan Rosenberg, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Mark Lanasa, MD
Affiliation: One MedImmune Way,Gaithersburg,Maryland,United States
Role: STUDY_DIRECTOR
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