# IMvigor011

Source: https://onco.cc/trials/imvigor011/  
OnCo record `imvigor011` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-04
- Registry id: NCT04660344
- Phase: 3
- Setting: Muscle-invasive bladder cancer after cystectomy, ctDNA-positive (Signatera): atezolizumab vs placebo
- Sponsor: Roche
- Enrolled: 761
- Result: DFS HR 0.64; OS HR 0.59 in ctDNA+.
- Outcomes: Disease-free survival (ctDNA-positive, randomised): Atezolizumab 9.9 months vs Placebo 4.8 months, HR 0.64; Overall survival (ctDNA-positive): Atezolizumab 32.8 months vs Placebo 21.1 months, HR 0.59; Disease-free survival at 12 months, persistently ctDNA-negative (untreated surveillance): ctDNA-negative, surveillance only 95.4%
- Replication: Contrasts with IMvigor010 (unselected adjuvant atezolizumab, negative), whose exploratory ctDNA analysis generated the hypothesis; IMvigor011 is the prospective confirmation.

## Sources

- ClinicalTrials.gov NCT04660344: https://clinicaltrials.gov/study/NCT04660344

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/)
- technologies: [MRD / molecular residual disease testing](https://onco.cc/technologies/mrd-testing/)
- drugs: [Atezolizumab](https://onco.cc/drugs/atezolizumab/), [Signatera](https://onco.cc/drugs/signatera/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- terms: [Circulating tumour DNA (ctDNA)](https://onco.cc/terms/ctdna/), [Enrichment and biomarker-stratified designs](https://onco.cc/terms/biomarker-stratified-design/), [Minimal / molecular residual disease (MRD)](https://onco.cc/terms/mrd/), [Non-muscle-invasive vs muscle-invasive bladder cancer (NMIBC / MIBC)](https://onco.cc/terms/nmibc-vs-mibc/), [SMART design (sequential multiple assignment randomised trial)](https://onco.cc/terms/smart-design/), [Stratified randomisation, allocation concealment and minimisation](https://onco.cc/terms/stratified-randomisation/), [Surrogate endpoint validation: which stand-ins have earned trust](https://onco.cc/terms/surrogate-validation/), [Tumour-informed versus tumour-naive ctDNA assays](https://onco.cc/terms/tumour-informed-assay/)
- people: [Thomas Powles](https://onco.cc/people/thomas-powles/)
- ideas: [A national platform trial that every ctDNA-positive patient can join](https://onco.cc/ideas/idea-bio2-national-mrd-platform/), [A national residual-disease weather service: serial blood tests for every curatively treated patient, pooled](https://onco.cc/ideas/idea-moon-mrd-weather-service/), [Biomarker-selected adjuvant therapy in RCC (ctDNA, CAIX PET, gene signatures)](https://onco.cc/ideas/idea-adjuvant-selection-rcc/), [ctDNA-guided adjuvant therapy in stage II-III melanoma](https://onco.cc/ideas/idea-ctdna-guided-adjuvant-melanoma/), [ctDNA-triggered escalation in early TNBC](https://onco.cc/ideas/idea-ctdna-escalation-tnbc/), [Formally qualify tumour-DNA blood tests as a surrogate endpoint for adjuvant trials](https://onco.cc/ideas/idea-tr2-ctdna-mrd-qualification/), [Use tumour DNA in blood to decide when to pause treatment in metastatic cancer](https://onco.cc/ideas/idea-tr1-ctdna-guided-stop-in-metastatic-disease/)
- pairings: [ctDNA MRD → adjuvant therapy decision](https://onco.cc/pairings/ctdna-mrd-to-adjuvant/)
- bottlenecks: [Dormant cells and minimal residual disease](https://onco.cc/bottlenecks/b-dormancy-mrd/), [Metastasis is understood least and studied last](https://onco.cc/bottlenecks/b-metastasis-biology/)
- pathways: [Clonal evolution & minimal residual disease](https://onco.cc/pathways/clonal-evolution/)
- key papers: [IMvigor011: using a blood test for leftover cancer to decide who gets immunotherapy after bladder surgery](https://onco.cc/key-papers/paper-imvigor011-nejm-2025/)
- roadmaps: [ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment](https://onco.cc/roadmaps/ctdna-tests/), [Diagnostics roadmap: stains → gene panels → blood tests that decide treatment](https://onco.cc/roadmaps/diagnostics-roadmap/), [Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on](https://onco.cc/roadmaps/trial-modernisation-roadmap/)

---
JSON: https://onco.cc/api/v1/entities/imvigor011.json