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

Completed · Phase 3 · Has a placebo group

Conditions studied: Locally Advanced Cervical Cancer

In brief

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

Key facts

Study ID

NCT03830866

Run by

AstraZeneca

People needed

770

Starts

2019-02-15

Expected to finish

2023-07-03

Last updated by the study team

2024-07-26

Who can join

Age: 18 and older, up to 130. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• For inclusion in the study, patients should fulfill the following criteria:
• Female
• Aged at least 18 years
• Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO (2009) Stages IB2 to IIB node positive or FIGO (2009) IIIA-IVA any node
• No prior chemotherapy or radiotherapy for cervical cancer
• WHO/ECOG performance status of 0-1
• At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion at baseline.

You may not qualify if…

• Patients should not enter the study if any of the following exclusion criteria are fulfilled:
• Diagnosis of small cell (neuroendocrine) histology or mucinous adenocarcinoma cervical cancer
• Intent to administer a fertility-sparing treatment regimen
• Undergone a previous hysterectomy
• Evidence of metastatic disease per RECIST 1.1 including lymph nodes ≥15 mm (short axis) above the L1 cephalad body, in the inguinal region or outside the planned radiation field.
• History of allogeneic organ transplantation
• Active or prior documented autoimmune or inflammatory disorders
• Uncontrolled intercurrent illness
• History of another primary malignancy and active primary immunodeficiency

Where it is running

• Research Site — La Jolla, California, United States
• Research Site — Orange, California, United States
• Research Site — Fort Myers, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Augusta, Georgia, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Lake Success, New York, United States
• Research Site — The Bronx, New York, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Dallas, Texas, United States
• Research Site — Dallas, Texas, United States
• Research Site — Spring, Texas, United States
• Research Site — Barretos, Brazil
• Research Site — Fortaleza, Brazil
• Research Site — Londrina, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Rio de Janeiro, Brazil
• Research Site — São José do Rio Preto, Brazil
• Research Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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