Loading
The first trial to use a blood test for leftover cancer to decide who gets immunotherapy, and it worked.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
761 enrolled.
12-month OS 100% in this group
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survival (ctDNA-positive, randomised)primary | Atezolizumab | 167 | 9.9 months | 0.64 (0.47 to 0.88) | 0.005 | link |
| Placebo | 83 | 4.8 months | ||||
| Overall survival (ctDNA-positive) | Atezolizumab | - | 32.8 months | 0.59 (0.41 to 0.86) | 0.005 | link |
| Placebo | - | 21.1 months | ||||
| Disease-free survival at 12 months, persistently ctDNA-negative (untreated surveillance) | ctDNA-negative, surveillance only | 357 | 95.4% | - | - | link |
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares SMART design (sequential multiple assignment randomised trial), Use tumour DNA in blood to decide when to pause treatment in metastatic cancer, A national residual-disease weather service: serial blood tests for every curatively treated patient, pooled, A national platform trial that every ctDNA-positive patient can join.
Shares Formally qualify tumour-DNA blood tests as a surrogate endpoint for adjuvant trials, Signatera, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, Metastasis is understood least and studied last.
Shares A national platform trial that every ctDNA-positive patient can join, Formally qualify tumour-DNA blood tests as a surrogate endpoint for adjuvant trials, Signatera, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment.
Shares Tumour-informed versus tumour-naive ctDNA assays, Signatera, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment.
Shares Formally qualify tumour-DNA blood tests as a surrogate endpoint for adjuvant trials, Tumour-informed versus tumour-naive ctDNA assays, Signatera, ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment.
Shares ctDNA MRD → adjuvant therapy decision, Tumour-informed versus tumour-naive ctDNA assays, Signatera, ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment.
Shares Tumour-informed versus tumour-naive ctDNA assays, Signatera, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment.
Shares ctDNA MRD → adjuvant therapy decision, Tumour-informed versus tumour-naive ctDNA assays, Signatera, ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/