Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA) (CALLA)
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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
Last Update Posted : October 14, 2022
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Condition or disease | Intervention/treatment | Phase |
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Locally Advanced Cervical Cancer | Biological: Durvalumab Drug: Cisplatin Drug: Carboplatin Radiation: external beam radiation therapy (EBRT) + brachytherapy | Phase 3 |
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 |

Arm | Intervention/treatment |
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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
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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)
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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 |
- The efficacy of durvalumab + SoC CCRT compared to placebo + SoC CCRT in terms of Progression-Free Survival (PFS) [ Time Frame: Estimated to be from the time of randomization up to 4.5 years ]Progression-Free Survival is defined as the time from randomization until the date of objective disease progression (RECIST 1.1 or histopathologic evidence) or death (by any cause in the absence of progression).
- The efficacy of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by the time from the date of randomization until death due to any cause in terms of Overall Survival (OS) [ Time Frame: Estimated to be from the time of randomization up to 5 years ]The analysis of OS will be based on time from date of randomization until the date of death by any cause
- The efficacy of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by proportion of patients with a complete response at the first tumor assessment after chemoradiotherapy in terms of Complete Response (CR) rate [ Time Frame: Estimated to be up to 20 weeks ]The analysis of CR rate will be based on investigator assessments using RECIST 1.1 or histopathologic assessment of local disease progression.
- The efficacy of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by the number (%) of patients with at least one visit response of Complete Response (CR) or partial response (PR) in terms of Objective Response Rate (ORR) [ Time Frame: Estimated to be up to 4.5 years ]The analysis of ORR will be based on investigator assessments using RECIST 1.1 or histopathologic assessment of local disease progression.
- The efficacy of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by time from detection of CR until the date of disease progression in terms of Duration of Response (DoR) in patients with a Complete Response (CR) [ Time Frame: Estimated up to 4.5 years ]The analysis of DoR in patients with a CR will be based on investigator assessments using RECIST 1.1 or histopathologic confirmation of local disease progression.
- Disease-related symptoms and health related quality of life (HRQoL) in patients treated with durvalumab + SoC CCRT compared with placebo + SoC CCRT as assessed by the change from baseline in disease-related symptoms and HRQoL [ Time Frame: Estimated up to 4.5 years ]The analysis of disease-related symptoms and HRQoL based on European Organization for Research and Treatment of Cancer (EORTC) core cancer instrument (EORTC QLQ-C30)
- Disease-related symptoms and health related quality of life (HRQoL) in patients treated with durvalumab + SoC CCRT compared with placebo + SoC CCRT as assessed by the change from baseline in disease-related symptoms and HRQoL [ Time Frame: Estimated up to 4.5 years ]The analysis of disease-related symptoms and HRQoL based on European Organization for Research and Treatment of Cancer (EORTC) supplemental cervical cancer module (EORTC CX24).
- To further assess the efficacy of durvalumab + SoC CCRT compared with placebo + SoC CCRT in terms of Proportion of patients alive and progression-free at 3 years (PFS 3 year). [ Time Frame: Estimated up to 4.5 years ]PFS (3 year) will be summarized (using the Kaplan-Meier curve) and presented by treatment arm.
- The efficacy of durvalumab + SoC CCRT compared with placebo + SoC CCRT in terms of PFS in PD-L1 positive patients [ Time Frame: Estimated up to 4.5 years ]Time from date of randomization until tumor progression or death due to any cause in patients who are PD-L1 positive
- The efficacy of durvalumab + SoC CCRT compared with placebo + SoC CCRT in terms of OS in PD-L1 positive patients [ Time Frame: Estimated up to 5 years ]Time from date of randomization until date of death by any cause in patients who are PD-L1 positive
- Number of participants with adverse events as assessed by Common Toxicity Criteria for Adverse Events (CTCAE v5.0) [ Time Frame: Estimated to be up to 2.5 years ]Type, frequency and severity of adverse events (including those from the pre- and post-treatment periods) will be listed according to CTCAE v5.0
- The safety and tolerability of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by electrocardiograms (ECGs) [ Time Frame: Estimated to be up to 2.5 years ]Resting 12-lead ECGs will be assessed by QTcF interval (ms).
- The safety and tolerability of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by vital signs(pulse rate) in beats per minute. [ Time Frame: Estimated to be up to 2.5 years ]Pulse rate will be evaluated according to the schedule of assessments.
- The safety and tolerability of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by vital signs(temperature) in degree Celsius. [ Time Frame: Estimated to be up to 2.5 years ]Temperature will be evaluated according to the schedule of assessments.
- The safety and tolerability of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by vital signs(respiration rate) in breaths per minute. [ Time Frame: Estimated to be up to 2.5 years ]Respiration rate will be evaluated according to the schedule of assessments.
- The safety and tolerability of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by vital signs(blood pressure). [ Time Frame: Estimated to be up to 2.5 years ]Blood pressure will be evaluated according to the schedule of assessments.
- The safety and tolerability of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by abnormality in clinical chemistry. [ Time Frame: Estimated to be up to 2.5 years ]Clinical chemistry will be assessed by liver function(Alanine aminotransferase, Aspartate aminotransferase, albumin, total bilirubin), kidney function (e.g. Urea, Creatinine) and endocrine function(TSH, T3 free,T4 free).
- The safety and tolerability of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by abnormality in hematology(cells/L). [ Time Frame: Estimated to be up to 2.5 years ]Hematology will be assessed by white cell count, platelet count, absolute neutrophil count and absolute lymphocyte count.
- The safety and tolerability of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by abnormality in hematology(g/L). [ Time Frame: Estimated to be up to 2.5 years ]Hematology will be assessed by haemoglobin.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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

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

Study Director: | Urban Scheuring, M.D., Ph.D. | AstraZeneca | |
Principal Investigator: | Bradley Monk, M.D | University of Arizona, Arizona, USA |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT03830866 |
Other Study ID Numbers: |
D9100C00001 |
First Posted: | February 5, 2019 Key Record Dates |
Last Update Posted: | October 14, 2022 |
Last Verified: | October 2022 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Durvalumab Chemoradiotherapy Locally Advanced Cervical Cancer |
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases |
Uterine Diseases Cisplatin Carboplatin Durvalumab Antineoplastic Agents Antineoplastic Agents, Immunological |