The Absolute Effect / Oncology Evidence / Evidence Index

Cervical Cancer · Medical · Definitive / Local Treatment · Locally advanced cervical cancer · durvalumab with CRT

CALLA

In locally advanced cervical cancer treated with chemoradiotherapy, does adding and continuing durvalumab improve PFS over chemoradiotherapy alone?

Registry: NCT03830866 · Evidence reviewed 9 November 2026 · Aliases and follow-up publications consolidated.

Phase III double-blind placebo-controlled; n=770.Primary-source evidence summary

Study design, population and eligibility

Design and sample

Phase III double-blind placebo-controlled; n=770.

Population

Previously untreated locally advanced cervical cancer FIGO 2009 IB2–IIB node-positive or ≥III.

Treatment and comparator

Intervention: Durvalumab with and after chemoradiotherapy up to 24 cycles.

Comparator: Placebo with and after chemoradiotherapy.

Endpoints

Investigator-assessed PFS primary.

Key efficacy and clinical outcomes

PFS HR .84 (95% CI .65–1.08; p=.17); 12-mo PFS 76.0% vs 73.3%; negative in all-comers.

Source-reported outcome visualization

Values are reproduced from the cited report; bars are scaled within this figure. Locally advanced cervical cancer · durvalumab with CRT

12-mo PFS durvalumab+CRT
76%
12-mo PFS placebo+CRT
73.3%

Median survival and hazard ratios are not fixed-time event risks; NNT is not inferred from them.

Toxicity and treatment burden

Grade 3–4 anaemia 20% vs 15%; serious AEs 28% vs 23%; 5 vs 1 treatment-related deaths.

Absolute effect and NNT/NNH

Negative phase III all-comers study; do not infer benefit from KEYNOTE-A18 pembrolizumab data.

NNT/NNH is not calculated unless a directly reported, comparable fixed-time risk difference supports it. Median survival and hazard ratios alone do not provide an NNT.

Critical interpretation and limitations

Negative phase III all-comers study; do not infer benefit from KEYNOTE-A18 pembrolizumab data.

This page is an evidence summary, not a substitute for multidisciplinary assessment or patient-specific decision-making.

Current-practice context

Review date: 9 November 2026. Primary publication and selected follow-up sources were reviewed. Full disease-specific guideline, regulatory-label and sequencing audit remains pending; verify current local recommendations and biomarker eligibility before clinical application.

Primary publication and authoritative source

https://pubmed.ncbi.nlm.nih.gov/38039991/

ClinicalTrials.gov NCT03830866