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

NCT03830866

CompletedPhase 3

Sponsor: AstraZeneca

Conditions: Locally Advanced Cervical Cancer

Interventions: Durvalumab, Cisplatin, Carboplatin, external beam radiation therapy (EBRT) + brachytherapy

Countries: United States, Brazil, Chile, China, Hungary, India, Japan, Mexico

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

Eligibility overview

Sex: FEMALE

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (117)
  • Phoenix, Arizona, United States
  • La Jolla, California, United States
  • Orange, California, United States
  • Fort Myers, Florida, United States
  • Miami, Florida, United States
  • Augusta, Georgia, United States
  • Ann Arbor, Michigan, United States
  • Lake Success, New York, United States
  • The Bronx, New York, United States
  • Cleveland, Ohio, United States
  • Cleveland, Ohio, United States
  • Cleveland, Ohio, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • Dallas, Texas, United States
  • Spring, Texas, United States
  • Barretos, Brazil
  • Fortaleza, Brazil
  • Londrina, Brazil
  • Porto Alegre, Brazil
  • Porto Alegre, Brazil
  • Porto Alegre, Brazil
  • Porto Alegre, Brazil
  • Rio de Janeiro, Brazil
  • São José do Rio Preto, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • Antofagasta, Chile
  • + 87 more on CT.gov