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Clinical Trials List

Protocol NumberD9100C00001
NCT Number(ClinicalTrials.gov Identfier)NCT03830866

2019-06-10 - 2024-04-24

Phase III

Terminated6

ICD-10C53

Malignant neoplasm of cervix uteri

ICD-10D06

Carcinoma in situ of cervix uteri

ICD-9180.9

Malignant neoplasm of cervix uteri, unspecified

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 (CALLA)

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Peng-Hui Wang Division of Obstetrics & Gynecology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator Chien-Hsing Lu Division of Obstetrics & Gynecology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Wen-Fang Cheng Division of Obstetrics & Gynecology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 張志隆 Division of Obstetrics & Gynecology
MacKay Memorial Hospital

Co-Principal Investigator

  • 吳孟浩 Division of Radiation Therapy
  • 黃琬珺 Division of Obstetrics & Gynecology
  • 陳子健 Division of Obstetrics & Gynecology
  • 陳裕仁 Division of Radiation Therapy
  • 陳楨瑞 Division of Obstetrics & Gynecology
  • 李杰 Division of Radiation Therapy

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Angel Chao Division of Obstetrics & Gynecology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Locally Advanced Cervical Cancer

Objectives

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.

Test Drug

Durvalumab

Active Ingredient

Humanized anti-PD-L1 mAb

Dosage Form

Injection

Dosage

50

Endpoints

The efficacy of durvalumab + SoC CCRT compared to placebo + SoC CCRT in terms of Progression-Free Survival (PFS)

Inclution 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

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.

The Estimated Number of Participants

  • Taiwan

    36 participants

  • Global

    772 participants

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