CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 770 enrolled
Drug / intervention
Durvalumab +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03830866
NCT03830866Phase 3Completed

A Phase III, Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With and Following Chemoradiotherapy Compared to Chemoradiotherapy Alone for Treatment in Women With Locally Advanced Cervical Cancer

AstraZeneca·interventional·Posted Feb 5, 2019·Updated Jul 26, 2024

In Brief

A Phase 3 clinical trial evaluating Durvalumab, Cisplatin, and 2 other interventions for Locally Advanced Cervical Cancer. Completed, enrolled 770 participants across 117 sites in 15 countries.

Detailed Summary

This is a randomized, multi-center, double-blind, placebo-controlled, global, Phase III study to determine the efficacy and safety of durvalumab + Chemoradiotherapy versus Chemoradiotherapy alone as treatment in Women With Locally Advanced Cervical Cancer

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, Chile, China, Hungary, India, Japan, Mexico, Peru, Philippines, Poland, Russia, South Africa, South Korea, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 5, 2019
Enrollment StartFeb 15, 2019
Primary CompletionJan 20, 2022
Study CompletionJul 3, 2023
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.4 years ago

Interventions

Durvalumabbiological

IV infusion every 4 weeks

Cisplatindrug

Platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy

Carboplatindrug

For patients enrolled under CSP v2 and prior - platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy

external beam radiation therapy (EBRT) + brachytherapyradiation

Radiation therapy per standard of care