Adults 18 to 130, female only, with Locally Advanced Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour ProgressionPrimary· 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
Group
Value
95% CI
Durvalumab + SoC CCRT
NA
NA – NA
Placebo + SoC CCRT
NA
NA – NA
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%Secondary· 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
Group
Value
95% CI
Durvalumab + SoC CCRT
NA
NA – NA
Placebo + SoC CCRT
NA
26.9 – NA
Overall Survival (Count)Secondary· 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
Group
Value
95% CI
Durvalumab + SoC CCRT
91
Placebo + SoC CCRT
112
Durvalumab + SoC CCRT
294
Placebo + SoC CCRT
273
Overall Survival (Duration)Secondary· 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
Group
Value
95% CI
Durvalumab + SoC CCRT
NA
NA – NA
Placebo + SoC CCRT
NA
NA – NA
Objective Response Rate (ORR)Secondary· 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
Group
Value
95% CI
Durvalumab + SoC CCRT
82.6
Placebo + SoC CCRT
80.5
Complete Response RateSecondary· 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)
Group
Value
95% CI
Durvalumab + SoC CCRT
42.9
Placebo + SoC CCRT
40.3
Duration of Response (DoR) in Patients With Complete Response (CR)Secondary· 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
Group
Value
95% CI
Durvalumab + SoC CCRT
NA
NA – NA
Placebo + SoC CCRT
NA
NA – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07507968 — TNT With FLOT/Durvalumab Plus Post-OP Durvalumab for Resectable Gastroesophageal Adenocarcinoma
· Phase 2
· not yet recruiting
NCT07332351 — Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle
· Phase 2
· not yet recruiting
NCT07339059 — Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Ce
· Phase 2
· recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
· Phase 1
· not yet recruiting
NCT07459634 — A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
· Phase 2
· not yet recruiting
Other recruiting trials for Locally Advanced Cervical Cancer
Currently open trials in the same condition.
NCT07338487 — A Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Cervical Canc
· Phase 1
· recruiting
NCT07055399 — Neoadjuvant Iparomlimab and Tuvonralimab Plus Chemotherapy-eclipse for Locally Advanced Cervical Cancer (NICE-CC)
· Phase 2
· recruiting
NCT06943833 — A Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (IVOLGA)
· Phase 2
· active not recruiting
NCT07205497 — QL1706 Plus Neoadjuvant Chemotherapy Followed by Type I Hysterectomy for Locally Advanced Cervical Cancer
· Phase 2
· active not recruiting
NCT07104149 — Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer
· Phase 2
· recruiting
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 26 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03830866.