{"entity":{"id":"ruby","kind":"trial","name":"RUBY / ENGOT-EN6 / GOG-3031","aka":[],"tldr":"Adding immunotherapy to first chemotherapy for advanced endometrial cancer extended life by more than a year on average, most dramatically in tumours with a broken DNA spell-checker.","summary":"In dMMR/MSI-H tumours, 24-month PFS was 61.4% vs 15.7% (HR 0.28); in the overall population PFS HR 0.64 (NEJM 2023). Overall survival in the overall population was 44.6 vs 28.2 months (HR 0.69; Annals of Oncology 2024), with dMMR OS HR 0.32. FDA approval July 2023 (dMMR) and August 2024 (all comers).","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03981796","url":"https://clinicaltrials.gov/study/NCT03981796"},{"label":"NEJM 2023","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2216334"},{"label":"OS, Annals of Oncology 2024","url":"https://www.annalsofoncology.org/article/S0923-7534(24)00721-X/fulltext"}],"tags":[],"related":[],"cancers":["endometrial","endometrial-mmr-deficient","advanced-recurrent-endometrial-cancer","uterine-carcinosarcoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["dostarlimab","carboplatin","paclitaxel"],"companies":["gog-foundation"],"institutions":[],"pathways":[],"terms":["msi"],"trials":[],"people":["mansoor-raza-mirza"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03981796","phase":"3","setting":"Primary advanced (stage III-IV) or first recurrent endometrial cancer: dostarlimab + carboplatin-paclitaxel, then dostarlimab up to 3 years, vs chemotherapy","sponsor":"GSK","result":"OS 44.6 vs 28.2 months overall (HR 0.69); dMMR PFS HR 0.28.","started":"2019-07-18","startedType":"actual","yearReported":2023,"enrolled":494,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 24 months (dMMR/MSI-H)","primary":true,"unit":"%","arms":[{"name":"Dostarlimab + chemo","value":61.4},{"name":"Placebo + chemo","value":15.7}],"hr":0.28,"ci":[0.16,0.5],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2216334"},{"endpoint":"Overall survival (overall population)","primary":true,"unit":"months","arms":[{"name":"Dostarlimab + chemo","n":245,"value":44.6},{"name":"Placebo + chemo","n":249,"value":28.2}],"hr":0.69,"ci":[0.54,0.89],"source":"https://www.annalsofoncology.org/article/S0923-7534(24)00721-X/fulltext"}],"replication":"NRG-GY018/KEYNOTE-868 (pembrolizumab) and DUO-E (durvalumab) reproduced the dMMR effect; RUBY is the only one with a reported all-comers OS benefit so far."},"route":"/trials/ruby/","neighbours":{"cancer":[{"id":"advanced-recurrent-endometrial-cancer","kind":"cancer","name":"Advanced or recurrent endometrial cancer","route":"/cancers/advanced-recurrent-endometrial-cancer/"},{"id":"endometrial","kind":"cancer","name":"Endometrial cancer","route":"/cancers/endometrial/"},{"id":"endometrial-nsmp","kind":"cancer","name":"Endometrial cancer with no specific molecular profile","route":"/cancers/endometrial-nsmp/"},{"id":"endometrial-mmr-deficient","kind":"cancer","name":"Mismatch-repair-deficient endometrial cancer","route":"/cancers/endometrial-mmr-deficient/"},{"id":"endometrial-p53-abnormal","kind":"cancer","name":"p53-abnormal endometrial cancer, including uterine serous carcinoma","route":"/cancers/endometrial-p53-abnormal/"},{"id":"uterine-carcinosarcoma","kind":"cancer","name":"Uterine carcinosarcoma","route":"/cancers/uterine-carcinosarcoma/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"dostarlimab","kind":"drug","name":"Dostarlimab","route":"/drugs/dostarlimab/"},{"id":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"}],"company":[{"id":"gog-foundation","kind":"company","name":"GOG Foundation","route":"/companies/gog-foundation/"}],"term":[{"id":"msi","kind":"term","name":"Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR)","route":"/terms/msi/"}],"person":[{"id":"mansoor-raza-mirza","kind":"person","name":"Mansoor Raza Mirza","route":"/people/mansoor-raza-mirza/"}],"pairing":[{"id":"chemo-io-first-line-endometrial","kind":"pairing","name":"Chemotherapy + PD-1/PD-L1 blockade, first-line advanced endometrial cancer","route":"/pairings/chemo-io-first-line-endometrial/"}],"institution":[{"id":"sgo","kind":"institution","name":"Society of Gynecologic Oncology","route":"/institutions/sgo/"}]}}