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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Locally Advanced Cervical Cancer

Treatments: Biological: Durvalumab; Drug: Carboplatin; Drug: Cisplatin; Radiation: external beam radiation therapy (EBRT) + brachytherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03830866

D9100C00001

2018-002872-42 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 770 patients

Sex: Female

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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770 participants in 2 patient groups, including a placebo group

Durvalumab (intravenous infusion)

Experimental group

Description:

durvalumab + standard of care concurrent chemoradiation therapy(SoC CCRT) followed by durvalumab monotherapy up to 24 months or until PD from the date of randomization

Treatment:

Radiation: external beam radiation therapy (EBRT) + brachytherapy

Drug: Cisplatin

Drug: Carboplatin

Biological: Durvalumab

Placebo (matching placebo for intravenous infusion)

Placebo Comparator group

Description:

placebo + standard of care concurrent chemoradiation therapy(SoC CCRT)

Treatment:

Radiation: external beam radiation therapy (EBRT) + brachytherapy

Drug: Cisplatin

Drug: Carboplatin