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

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 Jun 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Moscow, Russian Federation, 125367

Location

Research Site

Arkhangelsk, Russian Federation, 163045

Location

Research Site

Seoul, Republic of Korea, 05505

Location

Research Site

Seoul, Republic of Korea, 06351

Location

Research Site

Seoul, Republic of Korea, 08826

Location

Research Site

Seoul, Republic of Korea, 03722

Location

Research Site

Manila, Philippines, 1015

Location

Research Site

Makati, Philippines, 1229

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

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

Documents available

CSR synopsis
Download
CSR addendum
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Urban Scheuring

AstraZeneca

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

CSR synopsis

CSR addendum

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator