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



Status:Recruiting
Conditions:Cervical Cancer, Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - 127
Updated:3/22/2019
Start Date:February 15, 2019
End Date:April 16, 2024
Contact:AstraZeneca Clinical Study Information Center
Email:information.center@astrazeneca.com
Phone:1-877-240-9479

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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

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

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.

Inclusion Criteria:

For inclusion in the study, patients should fulfill the following criteria:

1. Female

2. Aged at least 18 years

3. Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO Stage
IB2-IIB Node positive or IIIA-IVA any node

4. No prior chemotherapy or radiotherapy for cervical cancer

5. WHO/ECOG performance status of 0-1

6. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target
Lesion at baseline.

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are
fulfilled:

1. Diagnosis of small cell (neuroendocrine) histology cervical cancer

2. Intent to administer a fertility-sparing treatment regimen

3. Undergone a previous hysterectomy

4. Evidence of metastatic disease per RECIST 1.1 including lymph nodes ≥15 mm (short
axis) above the L1 cephalad body or outside the planned radiation field.

5. History of allogeneic organ transplantation

6. Active or prior documented autoimmune or inflammatory disorders

7. Uncontrolled intercurrent illness

8. History of another primary malignancy and active primary immunodeficiency
We found this trial at
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5416 Avenida Brigadeiro Faria Lima
São José do Rio Preto, 15090
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