This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.
Female.
Aged at least 15 years at the time of screening. Note: Participants < 18 years of age: physical changes should be aligned with Tanner Stage III.
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.
Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.
Evidence of metastatic disease.
Intent to administer a fertility-sparing treatment regimen.
History of organ transplant or allogenic stem cell transplant.
Parallel
Volrustomig
Biological/VaccineIV Infusion
Placebo
Other interventionIV Infusion
Progression-free Survival (PFS) based on the investigator assessment in all randomized participants (FAS)
PFS is defined as the time from date of randomization until RECIST 1.1- defined radiological progression or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier.
Overall Survival (OS) in all randomized participants
OS defined as time from randomization until the date of death due to any cause.
Objective Response Rate (ORR) in all randomized participants
ORR is defined as the proportion of participants who have a CR or PR, as determined by Investigator per RECIST 1.1
Duration of Response (DoR) in all randomized participants
DoR in participants with a CR or PR: Time from date of first detection of CR or PR until the date of RECIST 1.1-defined radiological progression or histopathologically confirmed progression.
Time to First Subsequent Therapy or death (TFST) in all randomized participants
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.
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AstraZeneca
Lead sponsor
Gynecologic Oncology Group Foundation
Collaborator
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborator