{"entity":{"id":"keynote-826","kind":"trial","name":"KEYNOTE-826","aka":[],"tldr":"Added nearly ten months of life for women with advanced cervical cancer and made immunotherapy part of first-line treatment.","summary":"KEYNOTE-826, trial NCT03635567 sponsored by Merck and reported in 2021 with the final analysis in JCO in 2023, added nearly ten months of life for women with persistent, recurrent or metastatic cervical cancer and made immunotherapy part of first-line treatment. It randomised 617 patients to pembrolizumab or placebo with platinum and paclitaxel, with bevacizumab given to about 63 percent at investigator discretion, met its primary overall survival endpoints in all comers and in PD-L1-positive disease, and led to FDA approval in October 2021 for PD-L1-positive disease. OnCo links it to cervical and vaginal cancer, PD-1 as a target, pembrolizumab, bevacizumab, cisplatin, paclitaxel, the CPS term, Nicoletta Colombo and Bradley J. Monk. Whether PD-L1-negative patients benefit is the open question the label leaves.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03635567","url":"https://clinicaltrials.gov/study/NCT03635567"},{"label":"Final OS, JCO 2023","url":"https://ascopubs.org/doi/10.1200/JCO.23.00810"}],"tags":[],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["pembrolizumab","bevacizumab","cisplatin","paclitaxel"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["cps"],"trials":[],"people":["nicoletta-colombo","bradley-monk"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03635567","phase":"3","setting":"Persistent, recurrent, or metastatic cervical cancer, first line: pembrolizumab + platinum-paclitaxel ± bevacizumab vs placebo + chemotherapy ± bevacizumab","sponsor":"Merck","result":"OS 26.4 vs 16.8 months (HR 0.63), all comers.","started":"2018-10-25","startedType":"actual","yearReported":2021,"enrolled":617,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (all comers)","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + chemo ± bev","n":308,"value":26.4},{"name":"Placebo + chemo ± bev","n":309,"value":16.8}],"hr":0.63,"ci":[0.52,0.77],"source":"https://ascopubs.org/doi/10.1200/JCO.23.00810"},{"endpoint":"Overall survival (CPS ≥1)","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + chemo ± bev","value":28.6},{"name":"Placebo + chemo ± bev","value":16.5}],"hr":0.6,"ci":[0.49,0.74],"source":"https://ascopubs.org/doi/10.1200/JCO.23.00810"}],"replication":"BEATcc (atezolizumab + chemotherapy + bevacizumab) and COMPASSION-16 (cadonilimab) reproduced the first-line survival benefit with different antibodies."},"route":"/trials/keynote-826/","neighbours":{"cancer":[{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"},{"id":"recurrent-metastatic-cervical-cancer","kind":"cancer","name":"Recurrent or metastatic cervical cancer","route":"/cancers/recurrent-metastatic-cervical-cancer/"},{"id":"vaginal","kind":"cancer","name":"Vaginal cancer","route":"/cancers/vaginal/"},{"id":"vaginal-squamous-cell-carcinoma","kind":"cancer","name":"Vaginal squamous cell carcinoma (HPV-associated)","route":"/cancers/vaginal-squamous-cell-carcinoma/"}],"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":"bevacizumab","kind":"drug","name":"Bevacizumab","route":"/drugs/bevacizumab/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}],"term":[{"id":"cps","kind":"term","name":"Combined positive score (CPS)","route":"/terms/cps/"}],"person":[{"id":"bradley-monk","kind":"person","name":"Bradley J. Monk","route":"/people/bradley-monk/"},{"id":"nicoletta-colombo","kind":"person","name":"Nicoletta Colombo","route":"/people/nicoletta-colombo/"}],"paper":[{"id":"paper-keynote-826-nejm-2021","kind":"paper","name":"KEYNOTE-826: pembrolizumab plus chemotherapy with or without bevacizumab for persistent, recurrent or metastatic cervical cancer","route":"/key-papers/paper-keynote-826-nejm-2021/"}]}}