Study of Durvalumab with Chemoradiotherapy for Women with Locally Advanced Cervical Cancer (CALLA) - CALLA
Study identifier:D9100C00001
ClinicalTrials.gov identifier:NCT03830866
EudraCT identifier:2018-002872-42
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Locally Advanced Cervical Cancer
Phase
Phase 3
Healthy volunteers
No
Study drug
Cisplatin, Carboplatin
Sex
Female
Actual Enrollment
770
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 15 Feb 2019
Primary Completion Date: 20 Jan 2022
Study Completion Date: 03 Jul 2023
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Durvalumab (intravenous infusion) durvalumab + standard of care concurrent chemoradiation therapy(SoC CCRT) followed by durvalumab monotherapy up to 24 months or until PD from the date of randomization | Biological/Vaccine: 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 |
| Placebo Comparator: Placebo (matching placebo for intravenous infusion) placebo + standard of care concurrent chemoradiation therapy(SoC CCRT) | 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 |
Contacts
Investigators
Principal Investigator
Urban Scheuring
AstraZeneca
