Study of Durvalumab + Chemoradiotherapy or Chemoradiotherapy Alone for Women with Locally Advanced Cervical Cancer (CALLA).

Phase 1

• Conditions: Patient with FIGO (2009) Stages IB2 to IIB Node+ and IIIA to IVA withany node. Patients must not have previously received any definitivesurgical, radiation, or systemic therapy for cervical cancer and must beimmunotherapy-naïve.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002872-42-PL
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-28
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 714

Inclusion 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 nodal status.
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 571
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 143

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified