{"entity":{"id":"nct05061134","kind":"trial","name":"A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition","aka":["MONETTE"],"tldr":"A phase 2 trial of Ceralasertib, Durvalumab in melanoma, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition is a phase 2 interventional study registered as NCT05061134 by AstraZeneca, with 194 participants enrolled, started 2022-08-11 and due to reach its primary completion in 2024-04-12. Interventions recorded: Ceralasertib, Durvalumab. Conditions listed: Melanoma. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05061134","url":"https://clinicaltrials.gov/study/NCT05061134"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ceralasertib","durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05061134","phase":"2","setting":"A Randomised, Open-Label, Phase 2 Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Unresectable or Advanced Melanoma and Primary or Secondary Resistance to PD-(L)1 Inhibition","sponsor":"AstraZeneca","started":"2022-08-11","startedType":"actual","yearReported":2025,"enrolled":194,"enrolledBasis":"registry","outcomes":[{"endpoint":"Main Study: Objective Response Rate (ORR)","primary":true,"unit":"%","arms":[{"name":"Main Study: Ceralasertib + Durvalumab","n":97,"value":9.3,"note":"95% CI 4.3 to 16.9; Figures from the ClinicalTrials.gov results section (first posted 2025-05-21), not from a publication"},{"name":"Main Study: Ceralasertib Monotherapy","n":52,"value":5.8,"note":"95% CI 1.2 to 15.9"}],"source":"https://clinicaltrials.gov/study/NCT05061134?tab=results"},{"endpoint":"Main Study and Biopsy Study: Overall Survival (OS)","unit":"months","arms":[{"name":"Main Study: Ceralasertib + Durvalumab","n":100,"value":16,"note":"95% CI 10.48 to NA; Figures from the ClinicalTrials.gov results section (first posted 2025-05-21), not from a publication"},{"name":"Main Study: Ceralasertib Monotherapy","n":51,"value":12.32,"note":"95% CI 9.46 to NA"},{"name":"Biopsy Study: Ceralasertib + Durvalumab","n":41,"note":"Here, NA indicate that median and upper limit of 95% CI was not evaluable due to insufficient number of participants with events and due to the duration of fol…"}],"source":"https://clinicaltrials.gov/study/NCT05061134?tab=results"},{"endpoint":"Main Study and Biopsy Study: Progression Free Survival (PFS)","unit":"months","arms":[{"name":"Main Study: Ceralasertib + Durvalumab","n":100,"value":2,"note":"95% CI 1.91 to 3.52; Figures from the ClinicalTrials.gov results section (first posted 2025-05-21), not from a publication"},{"name":"Main Study: Ceralasertib Monotherapy","n":51,"value":1.94,"note":"95% CI 1.91 to 3.06"},{"name":"Biopsy Study: Ceralasertib + Durvalumab","n":41,"value":2.83,"note":"95% CI 2.76 to 4.47"}],"source":"https://clinicaltrials.gov/study/NCT05061134?tab=results"}]},"route":"/trials/nct05061134/","neighbours":{"cancer":[{"id":"advanced-melanoma","kind":"cancer","name":"Advanced melanoma (unresectable stage III and stage IV)","route":"/cancers/advanced-melanoma/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"ceralasertib","kind":"drug","name":"Ceralasertib","route":"/drugs/ceralasertib/"},{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}]}}