A Phase II Single-arm Multi-centre Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum Based, Concurrent Chemoradiation Therapy
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).
⁃ 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.