IMvigor011
The first trial to use a blood test for leftover cancer to decide who gets immunotherapy, and it worked.
DFS HR 0.64; OS HR 0.59 in ctDNA-positive patients; ctDNA-negative patients had excellent outcomes without treatment. FDA approval Q2 2026, the first ctDNA-guided indication.
- Median 9.9 vs 4.8 months with Atezolizumab compared with Placebo; about 5.1 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 36 percent lower chance of the event at any given time (hazard ratio 0.64, likely range 0.47 to 0.88).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- Median 32.8 vs 21.1 months with Atezolizumab compared with Placebo; about 11.7 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 41 percent lower chance of the event at any given time (hazard ratio 0.59, likely range 0.41 to 0.86).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 95.4 out of 100 people alive without the cancer coming back at 12 months with ctDNA-negative, surveillance only.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Muscle-invasive bladder cancer after cystectomy, ctDNA-positive (Signatera): atezolizumab vs placebo. People in a different situation may not see the same effect.
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 participants 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 (0.47–0.88) | 0.005 | link |
| Placebo | 83 | 4.8 months | ||||
| Overall survival (ctDNA-positive) | Atezolizumab | — | 32.8 months | 0.59 (0.41–0.86) | 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 |
Pages like this
not linked directly; found by shared links- TrialDYNAMIC
Shares Use tumour DNA in blood to decide when to pause treatment in metastatic cancer, A national platform trial that every ctDNA-positive patient can join, A national residual-disease weather service: serial blood tests for every curatively treated patient, pooled, Formally qualify tumour-DNA blood tests as a surrogate endpoint for adjuvant trials.
- TrialCIRCULATE-Japan (GALAXY / VEGA / ALTAIR)
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, Metastasis is understood least and studied last.
- IdeactDNA-guided adjuvant therapy as the default in stage II-III colon cancer
Shares Formally qualify tumour-DNA blood tests as a surrogate endpoint for adjuvant trials, Signatera, Metastasis is understood least and studied last, Dormant cells and minimal residual disease.
- Key paperGALAXY: tumour DNA in blood four weeks after bowel cancer surgery predicts relapse tenfold
Shares Formally qualify tumour-DNA blood tests as a surrogate endpoint for adjuvant trials, Signatera, Circulating tumour DNA (ctDNA), Dormant cells and minimal residual disease.
- IdeaA ring-fenced metastasis programme with metastasis-specific endpoints
Shares ctDNA-triggered escalation in early TNBC, Metastasis is understood least and studied last, Circulating tumour DNA (ctDNA), Minimal / molecular residual disease (MRD).
- Key paperTRACERx 421: the full-cohort picture of how lung cancer evolves and which subclones drive relapse
Shares Clonal evolution & minimal residual disease, Metastasis is understood least and studied last, Circulating tumour DNA (ctDNA), Dormant cells and minimal residual disease.
- IdeaBlunt the inflammation that wakes sleeping cancer cells
Shares Metastasis is understood least and studied last, Dormant cells and minimal residual disease, Minimal / molecular residual disease (MRD), MRD / molecular residual disease testing.
- IdeaIntercepting late recurrence with ctDNA surveillance and oral SERDs
Shares Signatera, Dormant cells and minimal residual disease, Minimal / molecular residual disease (MRD), MRD / molecular residual disease testing.