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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
316
Anti-PD-1 monoclonal antibody, IV infusion
IV infusion
IV infusion
Overall Survival (OS)
The time from the date of randomization until death
Time frame: 3 years
Progression-Free Survival (PFS) per RECIST 1.1
The time from the date of randomization until progression of disease according to RECIST 1.1 criteria or death
Time frame: 3 years
Progression-Free Survival (PFS) per iRECIST
The time from the date of randomization until progression of disease according to iRECIS criteria or death
Time frame: 3 years
Overall Response Rate per (ORR) RECIST 1.1
The percentage of the participants who have a Complete Response or a Partial Response as assessed by a blind independent central reviewer per RECIST 1.1
Time frame: 1 year
Overall Response Rate (ORR) per iRECIST
The percentage of the participants who have a Complete Response or a Partial Response as assessed by a blind independent central reviewer per iRECIST
Time frame: 1 year
Disease Control Rate (DCR)
The percentage of the participants who have a Complete Response, a Partial Response or a Stable DIsease as assessed by a blind independent central reviewer
Time frame: 1 year
Time to Response (TTR)
TTR will be calculated from the randomization date
Time frame: 1 year
Duration of Response (DOR)
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IV infusion
Placebo
Shanghai Tenth People's Hospital
Shanghai, China
RECRUITINGHigh technology Hospital Medcenter
Batumi, Georgia
RECRUITINGAcad. F.Todua Medical center "Research institute of Clinical Medicine"
Tbilisi, Georgia
RECRUITINGHigh Technology Medical Centre, University Clinic
Tbilisi, Georgia
RECRUITINGInstitute for Personalized Medicine Ltd.
Tbilisi, Georgia
RECRUITINGInstitute of Clinical Oncology
Tbilisi, Georgia
RECRUITINGLEPL First University Clinic of Tbilisi State Medical University
Tbilisi, Georgia
RECRUITINGMultiprofile Clinic Consilium Medulla
Tbilisi, Georgia
RECRUITINGNeo Medi
Tbilisi, Georgia
RECRUITINGCity Hospital No. 5
Barnaul, Russia
RECRUITING...and 16 more locations
DOR will be calculated from the moment of registration of response till event (progression or death)
Time frame: 1 year