Locally Advanced Cervical Cancer
Conditions
Keywords
Locally Advanced Cervical Cancer;, Volrustomig
Brief summary
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).
Detailed description
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.
Interventions
BIOLOGICALVolrustomig
IV infusion
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Intervention model description
All participants will receive volrustomig as IV infusions
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For inclusion in the study, patients should fulfill the following criteria: * Female. * Aged at least 18 years at the time of screening. * Body weight \> 35 kg. * Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease. * Initial staging procedures performed no more than 42 days prior to the first dose of CCRT. * Known PD-L1 status. * Must not have progressed following CCRT. * World Health Organization/The Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0 or 1. * Adequate organ and bone marrow function. * Capable of providing signed informed consent.
Exclusion criteria
Patients should not enter the study if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival at 24 months (PFS24) | From date of first dose until 24 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival at 36 months (OS36) | From date of first dose until 36 months. | OS36 is defined as the Kaplan-Meier estimate of OS at 36 months after study drug administration. |
| Progression-free Survival at 36 months (PFS36) | From date of first dose until 36 months. | 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 to First Subsequent Therapy or death (TFST) | From date of first dose until 36 months. | 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. |
Countries
Russia
Outcome results
None listed