Status:
COMPLETED
Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)
Lead Sponsor:
AstraZeneca
Conditions:
Locally Advanced Cervical Cancer
Eligibility:
FEMALE
18-130 years
Phase:
PHASE3
Brief 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 t...
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
February 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2023
Estimated Enrollment :
770 Patients enrolled
Trial Details
Trial ID
NCT03830866
Start Date
February 15 2019
End Date
July 3 2023
Last Update
July 26 2024
Active Locations (117)
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1
Research Site
Phoenix, Arizona, United States, 85016
2
Research Site
La Jolla, California, United States, 92093
3
Research Site
Orange, California, United States, 92868
4
Research Site
Fort Myers, Florida, United States, 33905