Phase III Global Study of Volrustomig Compared to Placebo in Women With High Risk Locally Advanced Cervical Cancer After Platinum-based Chemoradiation

What this Trial Is About

Researchers are evaluating the safety and effectiveness of volrustomig in women with high-risk locally advanced cervical cancer FIGO 2018 stage IIIA to IVA who have not experienced disease progression following platinum-based concurrent chemoradiation therapy CCRT. This phase III, randomized, double-blind, placebo-controlled global study aims to compare volrustomig with a placebo to gain insights into treatment outcomes for this patient group. Participants will be randomly assigned in a 11 ratio to receive either volrustomig or a placebo by intravenous infusion. The study compares these two groups over time to assess progression-free survival and other important outcomes. Treatment is given after patients complete platinum-based CCRT and have no disease progression. The study includes long-term follow-up for up to approximately seven years to monitor various measures such as survival, response rates, and side effects. Throughout the study, participants will undergo regular assessments including tumor sample analysis, physical exams, and evaluations of organ function and overall health. Researchers will track progression-free survival, overall survival, response rates, and patient-reported symptoms and quality of life. Safety and adverse events related to volrustomig will also be monitored closely during the study and follow-up period. Participation involves a long-term commitment with ongoing monitoring for up to seven years.

Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)