Evidence map›Paper›PMID 41110694›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2026

Adjuvant nivolumab versus placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274.

M D Galsky, J E Gschwend, M I Milowsky, M Schenker, B P Valderrama, Y Tomita, A Bamias, T Lebret, S F Shariat, S H Park and 11 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed.

  1. Article
  2. Treatment Patterns and Outcomes After Recurrence Following Adjuvant Nivolumab for Urothelial Carcinoma: An AGEHA Real-World Study.International journal of urology : official journal of the Japanese Urological Association · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

M D GalskyIcahn School of Medicine at Mount Sinai, New York, USA. Electronic address: matthew.galsky@mssm.edu.
J E GschwendTechnical University Munich, Munich, Germany.
M I MilowskyUniversity of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, USA.
M SchenkerSf. Nectarie Oncology Center, Craiova, Romania.
B P ValderramaHospital Universitario Virgen del Rocío, Sevilla, Spain.
Y TomitaNiigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
A BamiasNational and Kapodistrian University of Athens, Athens, Greece.
T LebretHôpital Foch, Paris-Saclay University UVSQ, Versailles, France.
S F ShariatMedical University of Vienna, Vienna General Hospital, Vienna, Austria.
S H ParkSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
M AgerbaekAarhus University Hospital, Aarhus, Denmark.
G JhaM Health Fairview Clinics and Surgery Center, Minneapolis, USA.
F StennerUniversity Hospital Basel, Basel, Switzerland.
D YeDepartment of Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
F GiudiciGlobal Biometric & Data Sciences, Bristol Myers Squibb, Boudry, Switzerland.
J ConnorsGlobal Drug Development, Bristol Myers Squibb, Princeton, USA.
S GuptaTranslational Medicine Oncology, Bristol Myers Squibb, Princeton, USA.
A ChhibberTranslational Medicine Oncology, Bristol Myers Squibb, Princeton, USA.
J ZhangOncology Clinical Development, Bristol Myers Squibb, Princeton, USA.
D F BajorinMemorial Sloan Kettering Cancer Center, New York, USA.
J A WitjesRadboud University, Nijmegen, Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite surgery, recurrence rates remain high in muscle-invasive urothelial carcinoma (MIUC). The phase III randomized, double-blind, multicenter CheckMate 274 trial comparing adjuvant nivolumab versus placebo in patients with high-risk MIUC after radical surgery demonstrated that adjuvant nivolumab improved disease-free survival (DFS) versus placebo. We report results with 5-year minimum follow-up including exploratory analyses of circulating tumor DNA (ctDNA). PATIENTS AND

methodsEligible patients had radical surgery (R0, with negative surgical margins) within 120 days before being randomized, with or without neoadjuvant cisplatin-based chemotherapy. Overall, 709 patients with MIUC at high risk of recurrence after surgery were randomly assigned 1:1 to nivolumab 240 mg or placebo every 2 weeks for ≤1 year. The primary endpoint was DFS. Overall survival (OS) was a key secondary endpoint. In a post hoc exploratory analysis, baseline ctDNA was measured using the Signatera assay.

resultsMedian DFS was 21.9 months [95% confidence interval (CI) 18.8-36.9 months] with nivolumab versus 11.0 months (95% CI 8.3-16.6 months) with placebo in all randomized patients [hazard ratio (HR) 0.74, 95% CI 0.61-0.90], and 55.5 months (95% CI 25.8-66.5 months) versus 8.4 months (95% CI 5.6-20.0 months) in patients with tumor programmed death-ligand 1 expression ≥1% (HR 0.58, 95% CI 0.42-0.79). In all randomized patients, median OS was 75.0 months (95% CI 56.7 months-not estimable) with nivolumab versus 50.1 months (95% CI 38.0-72.1 months) with placebo (HR 0.83, 95% CI 0.67-1.02). Baseline ctDNA after radical surgery was detected in 54 (40.6%) of 133 assessable patients. Median DFS was 52.1 months (95% CI 19.4 months-not estimable) versus 5.0 months (95% CI 2.8-6.5 months) in patients with undetectable versus detectable ctDNA at baseline (HR 0.30, 95% CI 0.18-0.48). In patients included in the ctDNA analysis who had detectable ctDNA, the median DFS HR for nivolumab-treated patients versus placebo-treated patients was 0.35 (95% CI 0.18-0.66), while in patients with undetectable ctDNA, the HR for nivolumab-treated patients versus placebo-treated patients was 0.99 (95% CI 0.51-1.93). There were no new safety signals.

conclusionsFive-year results confirm durable DFS benefit and consistent safety profile for adjuvant nivolumab in high-risk MIUC. Post hoc exploratory ctDNA assessment identified patients at highest risk of recurrence and may inform tailored adjuvant therapy strategies, pending further validation.

Indexed as

Antineoplastic Agents, ImmunologicalCarcinoma, Transitional CellCirculating Tumor DNANivolumabUrinary Bladder NeoplasmsAdultAgedChemotherapy, AdjuvantDisease-Free SurvivalDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm InvasivenessAntineoplastic Agents, ImmunologicalCirculating Tumor DNANivolumabCheckMate 274muscle-invasive bladder cancernivolumaburothelial carcinoma

Identifiers

PMID41110694

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.