trialsTrialPositive

CheckMate 274

A year of nivolumab after bladder or upper-tract surgery reduces recurrence and, with long follow-up, extends life.

CheckMate 274, trial NCT02632409 sponsored by Bristol Myers Squibb and reported in 2021, showed that a year of adjuvant nivolumab after radical surgery for high-risk muscle-invasive urothelial carcinoma of the bladder or upper tract reduces recurrence and, with long follow-up, extends life. It randomised 709 patients to nivolumab or placebo, met its primary disease-free survival endpoint, and later showed an overall survival benefit that was larger in the bladder subset and durable at five years, leading to FDA approval in August 2021. OnCo links it to bladder cancer, nivolumab and Dean F. Bajorin. It now competes with perioperative approaches from NIAGARA and EV-303 and EV-304 and with ctDNA-guided adjuvant therapy, and where adjuvant nivolumab fits among them is the open question.

Setting

High-risk muscle-invasive urothelial carcinoma after radical surgery: adjuvant nivolumab 1 year vs placebo

Phase

Phase 3

Sponsor

BMS

Registry

Headline result

DFS HR 0.70; OS HR 0.83 (ITT), median 75 vs 50.1 months.

Started

2016-03-22

Reported

2021

Enrolled

709 enrolled

Replication

IMvigor010 (adjuvant atezolizumab, all-comers) was negative, but its ctDNA-positive subgroup led to IMvigor011, which was positive; AMBASSADOR (adjuvant pembrolizumab) improved DFS.

Outcomes

In plain words

What these results mean for people, not percentages

709 enrolled

Disease-free survivalprimarysurrogate endpoint

Median 22 vs 10.9 months with Nivolumab compared with Placebo; about 11.1 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 30 percent lower chance of the event at any given time (hazard ratio 0.7, likely range 0.57 to 0.85).

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.

Overall survival (ITT)survival endpoint

Median 75 vs 50.1 months with Nivolumab compared with Placebo; about 24.9 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 17 percent lower chance of the event at any given time (hazard ratio 0.83).

Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

Caveats

These results apply to the people the trial enrolled: High-risk muscle-invasive urothelial carcinoma after radical surgery: adjuvant nivolumab 1 year 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.

709 enrolled.

Disease-free survivalprimary

HR 0.7 (0.57 to 0.85)

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Overall survival (ITT)

HR 0.83

Download

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Disease-free survivalprimary	Nivolumab	353	22 months	0.7 (0.57 to 0.85)	-	link
Disease-free survivalprimary	Placebo	356	10.9 months	0.7 (0.57 to 0.85)	-	link
Overall survival (ITT)	Nivolumab	-	75 months	0.83	-	link
Overall survival (ITT)	Placebo	-	50.1 months	0.83	-	link

Replication

IMvigor010 (adjuvant atezolizumab, all-comers) was negative, but its ctDNA-positive subgroup led to IMvigor011, which was positive; AMBASSADOR (adjuvant pembrolizumab) improved DFS.

Connected

Similar pages

cancers

Bladder & urothelial cancer Muscle-invasive and advanced bladder cancer

technologies

Immune checkpoint inhibitors

drugs

ApprovedMonoclonal antibody (anti-PD-1)

Nivolumab · Opdivo / Opdivo Qvantig (SC)

people

Dean F. Bajorin