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.
AstraZeneca
Lead sponsor
Gynecologic Oncology Group Foundation
Collaborator
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborator