drugset / Trial / NCT04487587

A Phase II Clinical Trial of Cediranib and Olaparib Maintenance in Advanced Recurrent Cervical Cancer

NCT04487587

RandomizedParallel-groupTriple-blindTreatment

Summary

COMICE is a randomised, double blind placebo controlled Phase II trial. The trial is recruiting 108 patients with advanced recurrent cervical cancer who have completed their 1st line chemotherapy for advanced/recurrent disease. Patients will be randomised to either placebo Cediranib and Olaparib or active Cediranib and Olaparib and will remain on treatment until progression of disease, unacceptable toxicity or withdrawal of consent. Patients will be assessed for disease progression every 8 weeks through CT/MRI imaging. The primary end point is Progression Free Survival.

Timeline

Start
2018-10-09
Primary completion
2025-03-01
Completion
2026-03-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cediranib Small molecule 20 mg
Comparator Olaparib Small molecule 300 mg

Indications