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CALLA

Durvalumab versus placebo with chemoradiotherapy for locally advanced cervical cancer (CALLA)

Phase 3N = 770NCT03830866

Population
Adults with previously untreated locally advanced cervical cancer (adenocarcinoma, squamous or adenosquamous; FIGO 2009 stage IB2-IIB lymph-node positive, or stage III or higher with any lymph-node status), WHO or ECOG performance status 0 or 1
Design
Randomised (1:1), double-blind phase 3 trial at 105 hospitals in 15 countries: durvalumab 1500 mg or placebo every 4 weeks with and following chemoradiotherapy, for up to 24 cycles. Chemoradiotherapy: 45 Gy external-beam radiotherapy with weekly cisplatin 40 mg/m2 or carboplatin (AUC 2) for 5 weeks, then image-guided brachytherapy. Stratified by FIGO stage and node status and by geographical region.
Primary endpoint
PFS
Arms
  • Durvalumab with chemoradiotherapy (experimental, n = 385): Durvalumab 1500 mg every 4 weeks with and following chemoradiotherapy, up to 24 cycles
  • Placebo with chemoradiotherapy (control, n = 385): Placebo every 4 weeks with and following chemoradiotherapy, up to 24 cycles
People
Monk BJ
PFSHR 0.84 (95% CI 0.65–1.08)Δ 12-month PFS+2.7 points
Show the numbers
Results reported for CALLA
EndpointAnalysisDurvalumab with chemoradiotherapyPlacebo with chemoradiotherapyEffect
PFSprimaryMonk 202376% at 12 mo (71.3–80.0%)73.3% at 12 mo (68.4–77.5%)HR 0.84 (95% CI 0.65–1.08)P=0.17Median follow-up 18.5 months (IQR 13.2-21.5) in the durvalumab group and 18.4 months (13.2-23.7) in the placebo group; median PFS not reached in either group. PFS was assessed by the investigator using RECIST 1.1. Five treatment-related deaths occurred in the durvalumab group and one in the placebo group.
Results reported for CALLA
EndpointAnalysisDurvalumab with chemoradiotherapyPlacebo with chemoradiotherapyEffect
PFSprimaryMonk 202376% at 12 mo (71.3–80.0%)73.3% at 12 mo (68.4–77.5%)HR 0.84 (95% CI 0.65–1.08)P=0.17Median follow-up 18.5 months (IQR 13.2-21.5) in the durvalumab group and 18.4 months (13.2-23.7) in the placebo group; median PFS not reached in either group. PFS was assessed by the investigator using RECIST 1.1. Five treatment-related deaths occurred in the durvalumab group and one in the placebo group.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.840.65–1.08
Primary publication: Monk BJ, Toita T, Wu X, Vázquez Limón JC, Tarnawski R, Mandai M, et al. Durvalumab versus placebo with chemoradiotherapy for locally advanced cervical cancer (CALLA): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2023;24(12):1334-1348. PubMedDOI

Appears in

Sources

  1. Monk BJ, Toita T, Wu X, Vázquez Limón JC, Tarnawski R, Mandai M, et al. Durvalumab versus placebo with chemoradiotherapy for locally advanced cervical cancer (CALLA): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2023;24(12):1334-1348.

    PubMedDOI