Trial · NCT03830866
Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)
NCT03830866, Phase 3, Completed, AstraZeneca; results first posted 2023-03-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA). Trials, record NCT03830866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03830866
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)
- NCT number
- NCT03830866
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 770 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Locally Advanced Cervical Cancer
- Interventions
- Durvalumab, Cisplatin, Carboplatin, external beam radiation therapy (EBRT) + brachytherapy
- First posted
- 2019-02-05
- Last updated
- 2024-07-26
- Other registries' IDs
- eudract:2018-002872-42
- Results first posted
- 2023-03-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression | 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 | 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% | 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 | Overall Survival (Count) | 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 |
| Secondary | Overall Survival (Duration) | 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 |
| Secondary | Objective Response Rate (ORR) | 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 |
| Secondary | Complete Response Rate | 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) |
| Secondary | Duration of Response (DoR) in Patients With Complete Response (CR) | 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 |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression | 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 | Full Analysis Set | Months | MEDIAN |
| SECONDARY | 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% | 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 | PD-L1 Analysis Set | Months | MEDIAN |
| SECONDARY | Overall Survival (Count) | 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 | Full Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (Duration) | 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 | Full Analysis Set | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | 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 | Full analysis set | Percentage of Participants | NUMBER |
| SECONDARY | Complete Response Rate | 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 | Full analysis set | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DoR) in Patients With Complete Response (CR) | 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 | Full Analysis Set | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression | Durvalumab + SoC CCRT | NA | 95% Confidence Interval NA to NA | Months | |
| Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression | Placebo + SoC CCRT | NA | 95% Confidence Interval NA to NA | Months | |
| 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% | Durvalumab + SoC CCRT | NA | 95% Confidence Interval NA to NA | Months | |
| 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% | Placebo + SoC CCRT | NA | 95% Confidence Interval 26.9 to NA | Months | |
| Overall Survival (Count) | Durvalumab + SoC CCRT | Died | 91 | Participants | |
| Overall Survival (Count) | Placebo + SoC CCRT | Died | 112 | Participants | |
| Overall Survival (Count) | Durvalumab + SoC CCRT | Censored (includes subjects who withdrew consent and subjects who were lost to follow up) | 294 | Participants | |
| Overall Survival (Count) | Placebo + SoC CCRT | Censored (includes subjects who withdrew consent and subjects who were lost to follow up) | 273 | Participants | |
| Overall Survival (Duration) | Durvalumab + SoC CCRT | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (Duration) | Placebo + SoC CCRT | NA | 95% Confidence Interval NA to NA | Months |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Durvalumab + SoC CCRT | 385 | |
| Overall Study | STARTED | Placebo + SoC CCRT | 385 | |
| Overall Study | COMPLETED | Durvalumab + SoC CCRT | 268 | |
| Overall Study | COMPLETED | Placebo + SoC CCRT | 249 | |
| Overall Study | NOT COMPLETED | Durvalumab + SoC CCRT | 117 | |
| Overall Study | NOT COMPLETED | Placebo + SoC CCRT | 136 |
Source ClinicalTrials.gov
Adverse events420
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Aspartate aminotransferase increased | Investigations | Durva + SoC CCRT | 34 | 385 | 56 |
| other | Aspartate aminotransferase increased | Investigations | Placebo + SoC CCRT | 30 | 384 | 38 |
| other | Blood alkaline phosphatase increased | Investigations | Durva + SoC CCRT | 21 | 385 | 30 |
| other | Blood alkaline phosphatase increased | Investigations | Placebo + SoC CCRT | 13 | 384 | 17 |
| other | Blood creatinine increased | Investigations | Durva + SoC CCRT | 31 | 385 | 48 |
| other | Blood creatinine increased | Investigations | Placebo + SoC CCRT | 23 | 384 | 30 |
| other | Gamma-glutamyltransferase increased | Investigations | Durva + SoC CCRT | 30 | 385 | 41 |
| other | Gamma-glutamyltransferase increased | Investigations | Placebo + SoC CCRT | 28 | 384 | 37 |
| other | Lymphocyte count decreased | Investigations | Durva + SoC CCRT | 18 | 385 | 29 |
| other | Lymphocyte count decreased | Investigations | Placebo + SoC CCRT | 34 | 384 | 47 |
1 to 10 of 420Source ClinicalTrials.gov
See all 420 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Durva + SoC CCRT | 91 | 385 |
| Total, all-cause mortality | Placebo + SoC CCRT | 112 | 385 |
| Total, other adverse events | Durva + SoC CCRT | 373 | 385 |
| Total, other adverse events | Placebo + SoC CCRT | 368 | 384 |
| Total, serious adverse events | Durva + SoC CCRT | 113 | 385 |
| Total, serious adverse events | Placebo + SoC CCRT | 90 | 384 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Durva + SoC CCRT vs Placebo + SoC CCRT: deaths from any cause | Trial comparisons |
| Durva + SoC CCRT vs Placebo + SoC CCRT: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03830866
GET https://conductscience.org/api/trials/v1/NCT03830866/events?page=2