NCT03830866

Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 770 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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

Detailed description

Women will be randomized in a 1:1 ratio to receive treatment with concurrent durvalumab + standard of care (SoC) or Placebo + Soc, followed by durvalumab/placebo maintenance for 24 months.

Conditions

• Locally Advanced Cervical Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Durvalumab	IV infusion every 4 weeks
DRUG	Cisplatin	Platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy
DRUG	Carboplatin	For patients enrolled under CSP v2 and prior - platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy
RADIATION	external beam radiation therapy (EBRT) + brachytherapy	Radiation therapy per standard of care

Timeline

• Start date: 2019-02-15
• Primary completion: 2022-01-20
• Completion: 2023-07-03
• First posted: 2019-02-05
• Last updated: 2024-07-26
• Results posted: 2023-03-06

Locations

117 sites across 15 countries: United States, Brazil, Chile, China, Hungary, India, Japan, Mexico, Peru, Philippines, Poland, Russia, South Africa, South Korea, Taiwan

Regulatory

• FDA-regulated drug study