This is a phase II single-arm open-label study to investigate the efficacy and safety of volrustomig in women with FIGO 2018 stage IIIA to IVA cervical cancer who have not progressed following platinum-based concurrent chemoradiation therapy (CCRT).
This is a phase II, single-arm open-label study to explore the efficacy and safety of volrustomig (MEDI5752) in women with high-risk locally advanced cervical cancer (Federation of Gynecologists and Obstetricians (FIGO) 2018 Stage IIIA to IVA) who have not progressed following platinum-based CCRT. All participants will be assigned to receive volrustomig as intravenous (IV) infusions for up to end of treatment, or until Response Evaluation Criteria in Solid Tumors (RECIST) 1.1-defined radiological progression or histopathologically confirmed progression by Investigator assessment, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. The results of this study will provide clinical data on efficacy and safety of an innovation treatment in the new region - Russian Federation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
IV infusion
Research Site
Arkhangelsk, Russia
Research Site
Krasnoyarsk, Russia
Research Site
Moscow, Russia
Research Site
Moscow, Russia
Progression-free Survival at 24 months (PFS24)
PFS24 is defined as the Kaplan-Meier estimate of PFS at 24 months per RECIST 1.1 or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier.
Time frame: From date of first dose until 24 months.
Overall Survival at 36 months (OS36)
OS36 is defined as the Kaplan-Meier estimate of OS at 36 months after study drug administration.
Time frame: From date of first dose until 36 months.
Progression-free Survival at 36 months (PFS36)
PFS36 is defined as the Kaplan-Meier estimate of PFS at 36 months per RECIST 1.1- defined radiological progression or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier.
Time frame: From date of first dose until 36 months.
Time to First Subsequent Therapy or death (TFST)
TFST: The time from randomization until the start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause.
Time frame: From date of first dose until 36 months.
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Research Site
Moscow, Russia
Research Site
Moscow, Russia
Research Site
Moscow, Russia
Research Site
Moscow, Russia
Research Site
Saint Petersburg, Russia
Research Site
Saint Petersburg, Russia
...and 2 more locations