Overview

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

Status:
Active, not recruiting

Trial end date:
2023-06-30

Target enrollment:
0

Participant gender:
Female

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

AstraZeneca

Treatments:

Antibodies, Monoclonal
Carboplatin
Durvalumab

Criteria

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 (2009)
Stages IB2 to IIB node positive or FIGO (2009) 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 or mucinous adenocarcinoma 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, in the inguinal region 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