drugset / Trial / NCT03737643

Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients

NCT03737643 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.

Timeline

Start
2019-01-04
Primary completion
2025-03-17
Completion
2026-12-23

Outcome

Met primary endpoint

registry analysis (superiority test); Global Non-tBRCAm: SoC vs Global Non-tBRCAm: SoC+D+O; p <0.0001; Hazard Ratio (HR) 0.63 (95% CI 0.52 to 0.76); NCT03737643 ↗

registry analysis (superiority test); Global Non-tBRCAm: SoC vs Global Non-tBRCAm: SoC+D+O; p <0.0001; Hazard Ratio (HR) 0.49 (95% CI 0.34 to 0.69); NCT03737643 ↗

release “DUO-O Phase III trial showed treatment with a combination of Lynparza (olaparib), Imfinzi (durvalumab), chemotherapy and bevacizumab demonstrated a statistically significant and clinically meaningful improvement” astrazeneca.com ↗

release “The DUO-O trial interim progression-free survival analysis provide evidence for further improvement with olaparib and durvalumab combination versus chemotherapy and bevacizumab alone.” astrazeneca.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody — Intravenous
Subject Durvalumab Monoclonal antibody — Intravenous
Subject Olaparib Small molecule — Oral
Background Carboplatin Small molecule — —
Background Paclitaxel Small molecule — —

Indications