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

Trial Status: Active

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

Inclusion 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

California

San Diego
University of California San Diego
Status: ACTIVE

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: ACTIVE
New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Marcella West Aguilar
Phone: 214-648-1479

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.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
AstraZeneca Pharmaceuticals LP

  • Primary ID D9100C00001
  • Secondary IDs NCI-2019-07204
  • Clinicaltrials.gov ID NCT03830866