{"entity":{"id":"keynote-564","kind":"trial","name":"KEYNOTE-564","aka":[],"tldr":"The first drug to help kidney cancer patients live longer after surgery, and the first adjuvant immunotherapy in any solid tumour to show an overall survival gain.","summary":"KEYNOTE-564, trial NCT03142334 sponsored by Merck and reported in 2021, produced the first drug to help kidney cancer patients live longer after surgery, and the first adjuvant immunotherapy in any solid tumour to show an overall survival gain. It randomised 994 patients with clear-cell renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy, or with no evidence of disease after metastasectomy, to a year of pembrolizumab or placebo, met its primary disease-free survival endpoint and showed a survival benefit at five years, leading to FDA approval in November 2021. OnCo links it to renal cell carcinoma, pembrolizumab, the perioperative and nephrectomy terms, Toni K. Choueiri and the idea of biomarker-selected adjuvant therapy. Why pembrolizumab succeeded where three other adjuvant immunotherapy trials failed is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03142334","url":"https://clinicaltrials.gov/study/NCT03142334"}],"tags":[],"related":[],"cancers":["rcc","clear-cell-rcc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant","nephrectomy"],"trials":[],"people":["toni-choueiri"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03142334","phase":"3","setting":"Clear-cell RCC at intermediate-high or high risk of recurrence after nephrectomy (or M1 NED): adjuvant pembrolizumab 1 year vs placebo","sponsor":"Merck","result":"DFS HR 0.72; OS HR 0.62.","started":"2017-06-09","startedType":"actual","yearReported":2021,"enrolled":994,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival","primary":true,"arms":[{"name":"Pembrolizumab","n":496},{"name":"Placebo","n":498}],"hr":0.72,"ci":[0.59,0.87],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2106391"},{"endpoint":"Overall survival (57-month follow-up)","unit":"% alive","arms":[{"name":"Pembrolizumab","value":91.2},{"name":"Placebo","value":86}],"hr":0.62,"ci":[0.44,0.87],"p":"0.002","source":"https://www.targetedonc.com/view/adjuvant-pembrolizumab-offers-improved-os-in-keynote-564-trial-of-ccrcc"}],"replication":"Not replicated by atezolizumab (IMmotion010), nivolumab ± ipilimumab (CheckMate 914), or perioperative nivolumab (PROSPER); LITESPARK-022 (pembrolizumab ± belzutifan) is positive on DFS."},"route":"/trials/keynote-564/","neighbours":{"cancer":[{"id":"clear-cell-rcc","kind":"cancer","name":"Clear cell renal cell carcinoma","route":"/cancers/clear-cell-rcc/"},{"id":"rcc","kind":"cancer","name":"Renal cell carcinoma","route":"/cancers/rcc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}],"term":[{"id":"absolute-benefit","kind":"term","name":"Absolute versus relative benefit (number needed to treat)","route":"/terms/absolute-benefit/"},{"id":"double-blind","kind":"term","name":"Blinding (double-blind, open-label, placebo-controlled)","route":"/terms/double-blind/"},{"id":"efs","kind":"term","name":"Event-free / disease-free survival (EFS, DFS, iDFS, RFS)","route":"/terms/efs/"},{"id":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"},{"id":"nephrectomy","kind":"term","name":"Nephrectomy","route":"/terms/nephrectomy/"},{"id":"os","kind":"term","name":"Overall survival (OS)","route":"/terms/os/"},{"id":"placebo","kind":"term","name":"Placebo","route":"/terms/placebo/"}],"person":[{"id":"toni-choueiri","kind":"person","name":"Toni K. Choueiri","route":"/people/toni-choueiri/"}],"idea":[{"id":"idea-adjuvant-selection-rcc","kind":"idea","name":"Biomarker-selected adjuvant therapy in RCC (ctDNA, CAIX PET, gene signatures)","route":"/ideas/idea-adjuvant-selection-rcc/"}]}}