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Completed

NCT Number: NCT03830866

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

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

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Key information

Conditions

Locally Advanced Cervical Cancer

Age range

18 year–130 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Barretos, Brazil

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For inclusion in the study, patients should fulfill the following criteria:

  • Female
  • Aged at least 18 years
  • Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO (2009) Stages IB2 to IIB node positive or FIGO (2009) IIIA-IVA any node
  • No prior chemotherapy or radiotherapy for cervical cancer
  • WHO/ECOG performance status of 0-1
  • 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:

  • Diagnosis of small cell (neuroendocrine) histology or mucinous adenocarcinoma cervical cancer
  • Intent to administer a fertility-sparing treatment regimen
  • Undergone a previous hysterectomy
  • 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.
  • History of allogeneic organ transplantation
  • Active or prior documented autoimmune or inflammatory disorders
  • Uncontrolled intercurrent illness
  • History of another primary malignancy and active primary immunodeficiency

Treatment and study plan

Durvalumab

Biological

IV infusion every 4 weeks

Cisplatin

Drug

Platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy

carboplatin

Drug

For patients enrolled under CSP v2 and prior - platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy

external beam radiation therapy (EBRT) + brachytherapy

Radiation

Radiation therapy per standard of care

Primary outcomes

  1. Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression

    Time frame: Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months

    PFS defined as time from date of randomisation until date of tumour progression or death by any cause, regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression

Secondary outcomes

  1. Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression, PD-L1 Expression >= 1%

    Time frame: Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months

    PFS defined as time from date of randomisation until date of tumour progression or death by any cause, regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression

  2. Overall Survival (Count)

    Time frame: Time from date of randomisation until date of death by any cause, assessed up to the data cut-off date (3rd July 2023), assessed up to a maximum of 51.7 months

    Number of Participants with Overall Survival (OS) where OS was defined as the time from the date of randomisation until death by any cause

  3. Overall Survival (Duration)

    Time frame: Time from date of randomisation until date of death by any cause, assessed up to the data cut-off date (3rd July 2023), assessed up to a maximum of 51.7 months

    Time from the date of randomisation until death by any cause

  4. Objective Response Rate (ORR)

    Time frame: Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months

    Percentage of evaluable patients with an Investigator-assessed visit response of complete response (CR) or partial response (PR). CR defined as disappearance of all target and non-target lesions and no new lesions. PR defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion

  5. Complete Response Rate

    Time frame: Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months

    Percentage of evaluable patients with an overall visit response of Complete Response (disappearance of all target and non-target lesions)

  6. Duration of Response (DoR) in Patients With Complete Response (CR)

    Time frame: Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months

    Time from date of first documented CR until date of documented progression or death in the absence of progression. For patients who did not progress their DoR was their Progression-free survival censoring time

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: CALLA

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Feb 5, 2019
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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