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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 |
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.