{"entity":{"id":"nrg-gy018-keynote-868","kind":"trial","name":"NRG-GY018 / KEYNOTE-868","aka":[],"tldr":"NRG-GY018 is the pembrolizumab twin of RUBY: immunotherapy plus chemotherapy cut the risk of progression by 70% in dMMR tumours and 46% in the rest.","summary":"NRG-GY018, also KEYNOTE-868, trial NCT03914612 run by NRG Oncology with Merck support and published in the New England Journal of Medicine in 2023, is the pembrolizumab twin of RUBY: adding immunotherapy to carboplatin and paclitaxel, followed by pembrolizumab maintenance, cut the risk of progression by seventy percent in mismatch-repair-deficient advanced or recurrent endometrial cancer and by nearly half in the rest. It randomised 816 patients analysed by mismatch repair status, met its primary progression-free survival endpoint in both cohorts, and led to FDA approval in June 2024 regardless of mismatch repair status. OnCo links it to endometrial cancer, PD-1 as a target, pembrolizumab, NRG Oncology, the dMMR term, Ramez N. Eskander and the pairing of chemotherapy with PD-1 blockade. Whether mismatch-repair-proficient patients gain a survival benefit is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03914612","url":"https://clinicaltrials.gov/study/NCT03914612"},{"label":"NEJM 2023","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2302312"}],"tags":[],"related":[],"cancers":["endometrial","endometrial-mmr-deficient","advanced-recurrent-endometrial-cancer","endometrial-nsmp"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["pembrolizumab","carboplatin","paclitaxel"],"companies":["nrg-oncology","gog-foundation"],"institutions":[],"pathways":[],"terms":["msi"],"trials":[],"people":["ramez-eskander"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03914612","phase":"3","setting":"Advanced or recurrent endometrial cancer: pembrolizumab + carboplatin-paclitaxel then pembrolizumab maintenance vs chemotherapy, analysed by MMR status","sponsor":"NRG Oncology / Merck","result":"PFS HR 0.30 (dMMR), 0.54 (pMMR).","started":"2019-08-22","startedType":"actual","yearReported":2023,"enrolled":816,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (dMMR)","primary":true,"unit":"HR","arms":[{"name":"Pembrolizumab + chemo","n":112},{"name":"Placebo + chemo","n":113}],"hr":0.3,"ci":[0.19,0.48],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2302312"},{"endpoint":"Progression-free survival (pMMR)","primary":true,"unit":"HR","arms":[{"name":"Pembrolizumab + chemo","n":294},{"name":"Placebo + chemo","n":294}],"hr":0.54,"ci":[0.41,0.71],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2302312"}]},"route":"/trials/nrg-gy018-keynote-868/","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/"}],"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":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"gog-foundation","kind":"company","name":"GOG Foundation","route":"/companies/gog-foundation/"},{"id":"nrg-oncology","kind":"company","name":"NRG Oncology","route":"/companies/nrg-oncology/"}],"term":[{"id":"msi","kind":"term","name":"Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR)","route":"/terms/msi/"}],"person":[{"id":"ramez-eskander","kind":"person","name":"Ramez N. Eskander","route":"/people/ramez-eskander/"}],"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/"}]}}