Spots Global Cancer Trial Database for Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer (FERMATA)
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Trial Identification
Brief Title: Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer (FERMATA)
Official Title: An International Randomized Double-blind Clinical Trial of BCD-100 Plus Platinum-based Chemotherapy With and Without Bevacizumab Versus Placebo Plus Platinum-based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer
Study ID: NCT03912415
Conditions
Study Description
Brief Summary: This is a randomized, multicenter, double-blind, Phase 3 study of efficacy and safety of BCD-100 plus platinum-based chemotherapy with and without bevacizumab versus placebo plus platinum-based chemotherapy with and without bevacizumab
Detailed Description: Subjects will be randomized in a 1:1 ratio to receive either Test Regimen or Comparator Regimen as the first-line treatment for advanced cervical cancer. Subjects will receive study therapy Q3W until progression of the disease or signs of unacceptable toxicity. In the absence of dose-limiting toxicity chemotherapy should be continued for at least 6 cycles, then, upon Investigator's decision and/or subjects' wish, the use of chemotherapy can be stopped while maintenance therapy with BCD-100/Placebo with or without bevacizumab (depending on initial therapy choice) continues until disease progression.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Shanghai Tenth People's Hospital, Shanghai, , China
High technology Hospital Medcenter, Batumi, , Georgia
Acad. F.Todua Medical center "Research institute of Clinical Medicine", Tbilisi, , Georgia
High Technology Medical Centre, University Clinic, Tbilisi, , Georgia
Institute for Personalized Medicine Ltd., Tbilisi, , Georgia
Institute of Clinical Oncology, Tbilisi, , Georgia
LEPL First University Clinic of Tbilisi State Medical University, Tbilisi, , Georgia
Multiprofile Clinic Consilium Medulla, Tbilisi, , Georgia
Neo Medi, Tbilisi, , Georgia
City Hospital No. 5, Barnaul, , Russian Federation
Sverdlovsk Regional Oncology Center, Ekaterinburg, , Russian Federation
Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky, Krasnoyarsk, , Russian Federation
Moscow Clinical Scientific and Practical Center named A.S. Loginova, Moscow, , Russian Federation
N.N. Blokhin National Medical Research Center of Oncology (2), Moscow, , Russian Federation
State Health Care Institution "Moscow City Oncology Hospital № 62" Moscow Health Department, Moscow, , Russian Federation
Murmansk Regional Clinical Hospital named after P.A. Bayandina, Murmansk, , Russian Federation
Clinical Oncology Dispensary, Omsk, , Russian Federation
LLC "New Clinic", Pyatigorsk, , Russian Federation
AV Medical Group, Saint Petersburg, , Russian Federation
JSC "Modern Medical Technologies", Saint Petersburg, , Russian Federation
N.N. Petrov National Medical Research Center of Oncology (2), Saint Petersburg, , Russian Federation
Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological), Saint Petersburg, , Russian Federation
Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva ", Saransk, , Russian Federation
Stavropol Regional Clinical Oncology Center, Stavropol', , Russian Federation
Regional Clinical Oncology Hospital, Yaroslavl, , Russian Federation
Memorial Şişli Istanbul, Istanbul, , Turkey
Contact Details
Name: Yulia N Linkova, MD, PhD
Affiliation: Director of Clinical Development Department, BIOCAD
Role: STUDY_DIRECTOR
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