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

NCT03830866 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 770

Last updated 2024-07-26

Study results available
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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

Conditions

  • Locally Advanced Cervical Cancer

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Urban Scheuring, M.D., Ph.D. · AstraZeneca

  • Bradley Monk, M.D · University of Arizona, Arizona, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-15
Primary Completion
2022-01-20
Completion
2023-07-03
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Chile
  • China
  • Hungary
  • India
  • Japan
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Russia
  • South Africa
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03830866 on ClinicalTrials.gov