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

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