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NCT03830866: CALLA

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

Completed Phase 3 Results posted Last updated 26 July 2024
What this trial tests

Phase 3 trial testing Durvalumab in Locally Advanced Cervical Cancer in 770 participants. Completed in 3 July 2023.

Timeline
15 February 2019
Primary endpoint
20 January 2022
3 July 2023

Quick facts

Lead sponsorAstraZeneca
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment770
Start date15 February 2019
Primary completion20 January 2022
Estimated completion3 July 2023
Sites117 locations across South Africa, Japan, Russia, Peru, Chile, Taiwan, Hungary, Mexico

Drugs / interventions tested

Conditions studied

Sponsor

AstraZeneca — full company profile →

Who can join

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 Progression Primary · 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

GroupValue95% CI
Durvalumab + SoC CCRTNANA – NA
Placebo + SoC CCRTNANA – 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

GroupValue95% CI
Durvalumab + SoC CCRTNANA – NA
Placebo + SoC CCRTNA26.9 – 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

GroupValue95% CI
Durvalumab + SoC CCRT91
Placebo + SoC CCRT112
Durvalumab + SoC CCRT294
Placebo + SoC CCRT273
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

GroupValue95% CI
Durvalumab + SoC CCRTNANA – NA
Placebo + SoC CCRTNANA – 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

GroupValue95% CI
Durvalumab + SoC CCRT82.6
Placebo + SoC CCRT80.5
Complete Response Rate 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 overall visit response of Complete Response (disappearance of all target and non-target lesions)

GroupValue95% CI
Durvalumab + SoC CCRT42.9
Placebo + SoC CCRT40.3
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

GroupValue95% CI
Durvalumab + SoC CCRTNANA – NA
Placebo + SoC CCRTNANA – 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.

Durva + SoC CCRT
Serious: 113/385 (29%)
Deaths: 91/385
Placebo + SoC CCRT
Serious: 90/384 (23%)
Deaths: 112/385

Serious adverse events (156 terms)

ReactionSystemDurva + SoC CCRTPlacebo + SoC CCRT
AnaemiaBlood and lymphatic system disorders
Urinary tract infectionInfections and infestations
Vaginal haemorrhageReproductive system and breast disorders
Acute kidney injuryRenal and urinary disorders
Abdominal painGastrointestinal disorders
Radiation proctitisInjury, poisoning and procedural complications
Febrile neutropeniaBlood and lymphatic system disorders
HypokalaemiaMetabolism and nutrition disorders
Female genital tract fistulaReproductive system and breast disorders
Pulmonary embolismRespiratory, thoracic and mediastinal disorders
DiarrhoeaGastrointestinal disorders
PneumoniaInfections and infestations
Cystitis radiationInjury, poisoning and procedural complications
Platelet count decreasedInvestigations
HydronephrosisRenal and urinary disorders
Ureteric obstructionRenal and urinary disorders
ColitisGastrointestinal disorders
PyrexiaGeneral disorders
Covid-19Infections and infestations
MyelosuppressionBlood and lymphatic system disorders
SepsisInfections and infestations
Gastroenteritis radiationInjury, poisoning and procedural complications
Blood creatinine increasedInvestigations
Neutrophil count decreasedInvestigations
HypomagnesaemiaMetabolism and nutrition disorders
Other adverse events (54 terms — click to expand)

ReactionSystemDurva + SoC CCRTPlacebo + SoC CCRT
NauseaGastrointestinal disorders
AnaemiaBlood and lymphatic system disorders
DiarrhoeaGastrointestinal disorders
VomitingGastrointestinal disorders
ConstipationGastrointestinal disorders
Urinary tract infectionInfections and infestations
Decreased appetiteMetabolism and nutrition disorders
Neutrophil count decreasedInvestigations
White blood cell count decreasedInvestigations
NeutropeniaBlood and lymphatic system disorders
DysuriaRenal and urinary disorders
FatigueGeneral disorders
Platelet count decreasedInvestigations
HypothyroidismEndocrine disorders
LeukopeniaBlood and lymphatic system disorders
Abdominal painGastrointestinal disorders
HypokalaemiaMetabolism and nutrition disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Weight decreasedInvestigations
Back painMusculoskeletal and connective tissue disorders
HeadacheNervous system disorders
Alanine aminotransferase increasedInvestigations
InsomniaPsychiatric disorders
HypomagnesaemiaMetabolism and nutrition disorders
Pelvic painReproductive system and breast disorders
Covid-19Infections and infestations
LymphopeniaBlood and lymphatic system disorders
ThrombocytopeniaBlood and lymphatic system disorders
AstheniaGeneral disorders
PyrexiaGeneral disorders
Aspartate aminotransferase increasedInvestigations
Lymphocyte count decreasedInvestigations
Blood creatinine increasedInvestigations
Gamma-glutamyltransferase increasedInvestigations
Vaginal dischargeReproductive system and breast disorders
Abdominal pain upperGastrointestinal disorders
HyponatraemiaMetabolism and nutrition disorders
Vaginal haemorrhageReproductive system and breast disorders
Hot flushVascular disorders
Radiation skin injuryInjury, poisoning and procedural complications

Most-reported serious reactions: Anaemia, Urinary tract infection, Vaginal haemorrhage, Acute kidney injury, Abdominal pain, Radiation proctitis, Febrile neutropenia, Hypokalaemia.

Data from ClinicalTrials.gov NCT03830866 adverse events section.

Sponsor's own description

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):

  1. Type I interferon-mediated tumor immunity and its role in immunotherapy.
    Yu R, Zhu B, Chen D. · · 2022 · cited 229× · PMID 35292881 · DOI 10.1007/s00018-022-04219-z
  2. Durvalumab versus placebo with chemoradiotherapy for locally advanced cervical cancer (CALLA): a randomised, double-blind, phase 3 trial.
    Monk BJ, Toita T, Wu X, Vázquez Limón JC, et al · · 2023 · cited 149× · PMID 38039991 · DOI 10.1016/s1470-2045(23)00479-5
  3. Global challenges of radiotherapy for the treatment of locally advanced cervical cancer.
    Mayadev JS, Ke G, Mahantshetty U, Pereira MD, et al · · 2022 · cited 140× · PMID 35256434 · DOI 10.1136/ijgc-2021-003001
  4. Tumor Immunity and Immunotherapy for HPV-Related Cancers.
    Shamseddine AA, Burman B, Lee NY, Zamarin D, et al · · 2021 · cited 140× · PMID 33990345 · DOI 10.1158/2159-8290.cd-20-1760
  5. Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
    Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6
  6. Integration of immunotherapy into treatment of cervical cancer: Recent data and ongoing trials.
    Monk BJ, Enomoto T, Kast WM, McCormack M, et al · · 2022 · cited 105× · PMID 35413489 · DOI 10.1016/j.ctrv.2022.102385
  7. CALLA: Efficacy and safety of concurrent and adjuvant durvalumab with chemoradiotherapy versus chemoradiotherapy alone in women with locally advanced cervical cancer: a phase III, randomized, double-blind, multicenter study.
    Mayadev J, Nunes AT, Li M, Marcovitz M, et al · · 2020 · cited 73× · PMID 32447296 · DOI 10.1136/ijgc-2019-001135
  8. Advances in immunotherapy for cervical cancer.
    Wendel Naumann R, Leath CA. · · 2020 · cited 63× · PMID 32740092 · DOI 10.1097/cco.0000000000000663

Verify or expand the search:

Other trials of Durvalumab

Trials testing the same drug.

Other recruiting trials for Locally Advanced Cervical Cancer

Currently open trials in the same condition.

Other AstraZeneca trials

Trials by the same sponsor.

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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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing