drugset / Trial / NCT03340376

Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer

NCT03340376 ↗

Phase 2 Active not recruiting 48 enrolled Universitaire Ziekenhuizen KU Leuven Roche Pharma AG · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, multicenter, randomized phase II trial to evaluate the safety and efficacy of atezolizumab in patients with recurrent cervical cancer in second line therapy. A total of 48 patients will be randomized in 3 arms, each arm consisting of 16 patients: Arm A: atezolizumab monotherapy q3w Arm B: atezolizumab combined with doxorubicin q3w Arm C: doxorubicin monotherapy q3w

Timeline

Start
2017-08-30
Primary completion
2025-09
Completion
2025-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Doxorubicin Other / unclassified 75 mg/m2 Intravenous

Indications