{"entity":{"id":"imvigor011","kind":"trial","name":"IMvigor011","aka":[],"tldr":"The first trial to use a blood test for leftover cancer to decide who gets immunotherapy, and it worked.","summary":"IMvigor011, trial NCT04660344 sponsored by Roche and reported in 2025, was the first trial to use a blood test for leftover cancer to decide who gets immunotherapy, and it worked. It enrolled 761 patients after cystectomy for muscle-invasive bladder cancer, randomised those who were circulating tumour DNA-positive by Signatera to atezolizumab or placebo, met its primary disease-free survival endpoint and improved overall survival, while persistently ctDNA-negative patients had excellent outcomes without treatment, leading to FDA approval in the second quarter of 2026 as the first ctDNA-guided indication. Whether the approach transfers to other cancers is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT04660344","url":"https://clinicaltrials.gov/study/NCT04660344"}],"tags":[],"related":[],"cancers":["urothelial"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":["atezolizumab","signatera"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["mrd","ctdna"],"trials":[],"people":["thomas-powles"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04660344","phase":"3","setting":"Muscle-invasive bladder cancer after cystectomy, ctDNA-positive (Signatera): atezolizumab vs placebo","sponsor":"Roche","result":"DFS HR 0.64; OS HR 0.59 in ctDNA+.","started":"2021-05-03","startedType":"actual","yearReported":2025,"enrolled":761,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival (ctDNA-positive, randomised)","primary":true,"unit":"months","arms":[{"name":"Atezolizumab","n":167,"value":9.9},{"name":"Placebo","n":83,"value":4.8}],"hr":0.64,"ci":[0.47,0.88],"p":"0.005","source":"https://www.roche.com/media/releases/med-cor-2025-10-20b"},{"endpoint":"Overall survival (ctDNA-positive)","unit":"months","arms":[{"name":"Atezolizumab","value":32.8},{"name":"Placebo","value":21.1}],"hr":0.59,"ci":[0.41,0.86],"p":"0.005","source":"https://www.roche.com/media/releases/med-cor-2025-10-20b"},{"endpoint":"Disease-free survival at 12 months, persistently ctDNA-negative (untreated surveillance)","unit":"%","arms":[{"name":"ctDNA-negative, surveillance only","n":357,"value":95.4,"note":"12-month OS 100% in this group"}],"source":"https://www.roche.com/media/releases/med-cor-2025-10-20b"}],"replication":"Contrasts with IMvigor010 (unselected adjuvant atezolizumab, negative), whose exploratory ctDNA analysis generated the hypothesis; IMvigor011 is the prospective confirmation."},"route":"/trials/imvigor011/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"}],"technology":[{"id":"mrd-testing","kind":"technology","name":"MRD / molecular residual disease testing","route":"/technologies/mrd-testing/"}],"drug":[{"id":"atezolizumab","kind":"drug","name":"Atezolizumab","route":"/drugs/atezolizumab/"},{"id":"signatera","kind":"drug","name":"Signatera","route":"/drugs/signatera/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"term":[{"id":"ctdna","kind":"term","name":"Circulating tumour DNA (ctDNA)","route":"/terms/ctdna/"},{"id":"biomarker-stratified-design","kind":"term","name":"Enrichment and biomarker-stratified designs","route":"/terms/biomarker-stratified-design/"},{"id":"mrd","kind":"term","name":"Minimal / molecular residual disease (MRD)","route":"/terms/mrd/"},{"id":"nmibc-vs-mibc","kind":"term","name":"Non-muscle-invasive vs muscle-invasive bladder cancer (NMIBC / MIBC)","route":"/terms/nmibc-vs-mibc/"},{"id":"smart-design","kind":"term","name":"SMART design (sequential multiple assignment randomised trial)","route":"/terms/smart-design/"},{"id":"stratified-randomisation","kind":"term","name":"Stratified randomisation, allocation concealment and minimisation","route":"/terms/stratified-randomisation/"},{"id":"surrogate-validation","kind":"term","name":"Surrogate endpoint validation: which stand-ins have earned trust","route":"/terms/surrogate-validation/"},{"id":"tumour-informed-assay","kind":"term","name":"Tumour-informed versus tumour-naive ctDNA assays","route":"/terms/tumour-informed-assay/"}],"person":[{"id":"thomas-powles","kind":"person","name":"Thomas Powles","route":"/people/thomas-powles/"}],"idea":[{"id":"idea-bio2-national-mrd-platform","kind":"idea","name":"A national platform trial that every ctDNA-positive patient can join","route":"/ideas/idea-bio2-national-mrd-platform/"},{"id":"idea-moon-mrd-weather-service","kind":"idea","name":"A national residual-disease weather service: serial blood tests for every curatively treated patient, pooled","route":"/ideas/idea-moon-mrd-weather-service/"},{"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/"},{"id":"idea-ctdna-guided-adjuvant-melanoma","kind":"idea","name":"ctDNA-guided adjuvant therapy in stage II-III melanoma","route":"/ideas/idea-ctdna-guided-adjuvant-melanoma/"},{"id":"idea-ctdna-escalation-tnbc","kind":"idea","name":"ctDNA-triggered escalation in early TNBC","route":"/ideas/idea-ctdna-escalation-tnbc/"},{"id":"idea-tr2-ctdna-mrd-qualification","kind":"idea","name":"Formally qualify tumour-DNA blood tests as a surrogate endpoint for adjuvant trials","route":"/ideas/idea-tr2-ctdna-mrd-qualification/"},{"id":"idea-tr1-ctdna-guided-stop-in-metastatic-disease","kind":"idea","name":"Use tumour DNA in blood to decide when to pause treatment in metastatic cancer","route":"/ideas/idea-tr1-ctdna-guided-stop-in-metastatic-disease/"}],"pairing":[{"id":"ctdna-mrd-to-adjuvant","kind":"pairing","name":"ctDNA MRD → adjuvant therapy decision","route":"/pairings/ctdna-mrd-to-adjuvant/"}],"bottleneck":[{"id":"b-dormancy-mrd","kind":"bottleneck","name":"Dormant cells and minimal residual disease","route":"/bottlenecks/b-dormancy-mrd/"},{"id":"b-metastasis-biology","kind":"bottleneck","name":"Metastasis is understood least and studied last","route":"/bottlenecks/b-metastasis-biology/"}],"pathway":[{"id":"clonal-evolution","kind":"pathway","name":"Clonal evolution & minimal residual disease","route":"/pathways/clonal-evolution/"}],"paper":[{"id":"paper-imvigor011-nejm-2025","kind":"paper","name":"IMvigor011: using a blood test for leftover cancer to decide who gets immunotherapy after bladder surgery","route":"/key-papers/paper-imvigor011-nejm-2025/"}],"roadmap":[{"id":"ctdna-tests","kind":"roadmap","name":"ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment","route":"/roadmaps/ctdna-tests/"},{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"},{"id":"trial-modernisation-roadmap","kind":"roadmap","name":"Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on","route":"/roadmaps/trial-modernisation-roadmap/"}]}}