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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03830866
Recruitment Status : Active, not recruiting
First Posted : February 5, 2019
Results First Posted : March 6, 2023
Last Update Posted : April 19, 2023
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Locally Advanced Cervical Cancer Biological: Durvalumab Drug: Cisplatin Drug: Carboplatin Radiation: external beam radiation therapy (EBRT) + brachytherapy Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 770 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 15, 2019
Actual Primary Completion Date : January 20, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
Drug Information available for: Durvalumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Durvalumab (intravenous infusion)
durvalumab + standard of care concurrent chemoradiation therapy(SoC CCRT) followed by durvalumab monotherapy up to 24 months or until PD from the date of randomization
 Biological: Durvalumab
IV infusion every 4 weeks

Drug: Cisplatin
Platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy

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

Radiation: external beam radiation therapy (EBRT) + brachytherapy
Radiation therapy per standard of care
Placebo Comparator: Placebo (matching placebo for intravenous infusion)
placebo + standard of care concurrent chemoradiation therapy(SoC CCRT)
 Drug: Cisplatin
Platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy

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

Radiation: external beam radiation therapy (EBRT) + brachytherapy
Radiation therapy per standard of care


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 (20th January 2022), assessed up to a maximum of 34.3 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 (20th January 2022), assessed up to a maximum of 34.3 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female: only female participants are being studied
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830866


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Urban Scheuring, M.D., Ph.D. AstraZeneca
Principal Investigator: Bradley Monk, M.D University of Arizona, Arizona, USA
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Study Protocol  [PDF] March 11, 2021
Statistical Analysis Plan  [PDF] August 4, 2021

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03830866    
Other Study ID Numbers: D9100C00001
First Posted: February 5, 2019    Key Record Dates
Results First Posted: March 6, 2023
Last Update Posted: April 19, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Durvalumab
Chemoradiotherapy
Locally Advanced Cervical Cancer
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Carboplatin
Durvalumab
Antineoplastic Agents
Antineoplastic Agents, Immunological