{"entity":{"id":"calla","kind":"trial","name":"CALLA","aka":[],"tldr":"CALLA tested adding the PD-L1 antibody durvalumab to chemoradiotherapy for locally advanced cervical cancer and found no significant benefit, in contrast to the later positive KEYNOTE-A18 trial of pembrolizumab in a higher-risk population.","summary":"CALLA randomised 770 women with locally advanced cervical cancer (FIGO 2009 stage IB2 to IIB node-positive, or III to IVA) to durvalumab or placebo given with cisplatin-based external beam radiotherapy and brachytherapy and continued for up to 24 cycles. The primary endpoint was progression-free survival.\n\nDurvalumab did not significantly improve progression-free survival, though exploratory analyses suggested benefit in tumours with high PD-L1 expression. KEYNOTE-A18, which enrolled a higher-risk population and used pembrolizumab, reported a positive result the following year, and the reasons for the difference (population, agent, radiotherapy quality) are debated.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03830866","url":"https://clinicaltrials.gov/study/NCT03830866"}],"tags":["subtype-trials"],"related":[],"cancers":["locally-advanced-cervical-cancer","cervical"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","cisplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["bradley-monk"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03830866","phase":"3","setting":"Locally advanced cervical cancer: cisplatin chemoradiotherapy with durvalumab or placebo, durvalumab continued for up to two years","sponsor":"AstraZeneca","result":"Durvalumab added to chemoradiotherapy did not significantly improve progression-free survival in locally advanced cervical cancer.","started":"2019-02-15","startedType":"actual","yearReported":2023,"enrolled":770,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (investigator-assessed)","primary":true,"unit":"months","arms":[{"name":"Durvalumab + chemoradiotherapy","n":385,"note":"Not reached; median follow-up 18.5 months"},{"name":"Placebo + chemoradiotherapy","n":385,"note":"Not reached"}],"hr":0.84,"ci":[0.65,1.08],"p":"0.17","source":"https://doi.org/10.1016/s1470-2045(23)00479-5"},{"endpoint":"Progression-free survival at 12 months","unit":"%","arms":[{"name":"Durvalumab + chemoradiotherapy","n":385,"value":76},{"name":"Placebo + chemoradiotherapy","n":385,"value":73.3}],"source":"https://doi.org/10.1016/s1470-2045(23)00479-5"},{"endpoint":"Serious adverse events","unit":"%","arms":[{"name":"Durvalumab + chemoradiotherapy","n":385,"value":28},{"name":"Placebo + chemoradiotherapy","n":384,"value":23}],"source":"https://doi.org/10.1016/s1470-2045(23)00479-5"}]},"route":"/trials/calla/","neighbours":{"cancer":[{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"},{"id":"locally-advanced-cervical-cancer","kind":"cancer","name":"Locally advanced cervical cancer","route":"/cancers/locally-advanced-cervical-cancer/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"person":[{"id":"bradley-monk","kind":"person","name":"Bradley J. Monk","route":"/people/bradley-monk/"}]}}