Evidence map›Paper›PMID 32532789›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2020

Nivolumab in Patients with Advanced Platinum-resistant Urothelial Carcinoma: Efficacy, Safety, and Biomarker Analyses with Extended Follow-up from CheckMate 275.

Matthew D Galsky, Abdel Saci, Peter M Szabo, G Celine Han, Gary Grossfeld, Sandra Collette, Arlene Siefker-Radtke, Andrea Necchi, Padmanee Sharma

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 77 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
77citing papers in PubMed, 3 pooled it
17.6field-weighted citation impact, top 1% of its field
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

77 citing papers in PubMed, 3 syntheses or guidelines pooled it, 131 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
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  6. Trial
  7. A Phase II Trial of Guadecitabine plus Atezolizumab in Metastatic Urothelial Carcinoma Progressing after Initial Immune Checkpoint Inhibitor Therapy.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Trial
  8. Trial
  9. Article
  10. Fibroblast growth factor receptor 3 (FGFR3) alterations and response to immune checkpoint inhibition in metastatic urothelial carcinoma: a systematic review and meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  11. Review
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  13. Article
  14. IK-175, an Oral Aryl Hydrocarbon Receptor Inhibitor, Alone and with Nivolumab in Patients with Advanced Solid Tumors and Urothelial Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
  15. Review
  16. Review
  17. Review
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  20. Review

17 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 3 countries.

Matthew D GalskyIcahn School of Medicine at Mount Sinai/Tisch Cancer Institute, New York, New York. matthew.galsky@mssm.edu.ORCID 0000-0001-7655-9378
Abdel Saci *Bristol Myers Squibb, Princeton, New Jersey.
Peter M SzaboBristol Myers Squibb, Princeton, New Jersey.
G Celine HanBristol Myers Squibb, Princeton, New Jersey.
Gary GrossfeldBristol Myers Squibb, Princeton, New Jersey.
Sandra ColletteBristol Myers Squibb, Princeton, New Jersey.
Arlene Siefker-RadtkeMD Anderson Cancer Center, University of Texas, Houston, Texas.
Andrea NecchiFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Padmanee SharmaMD Anderson Cancer Center, University of Texas, Houston, Texas.
Bristol-Myers Squibb (Sweden) · SEThe University of Texas MD Anderson Cancer Center · USFondazione IRCCS Istituto Nazionale dei Tumori · ITTisch Hospital · US

Funding

Dissecting myeloid cell-mediated resistance to immune checkpoint blockade in bladder cancerR01CA249175 · NCI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI BHARDWAJ, NINA, GALSKY, MATTHEW · 2020 to 2024
$3.5M
NCI NIH HHS R01 CA249175
6 · The paper itself

Abstract

purposeWe report efficacy and safety with extended follow-up, and exploratory biomarker analyses from the phase II CheckMate 275 trial to identify biomarkers of response to nivolumab in platinum-resistant metastatic or unresectable urothelial carcinoma (mUC). PATIENTS AND

methodsPatients received nivolumab 3 mg/kg once every 2 weeks until disease progression, unacceptable toxicity, or other protocol-defined reasons. The primary endpoint was objective response rate (ORR) per blinded independent review committee (BIRC; using RECIST v1.1) in all treated patients and by tumor PD-L1 expression. Key secondary endpoints were progression-free survival (PFS) per BIRC using RECIST v1.1 and overall survival (OS) in all patients and by PD-L1 expression. Exploratory endpoints included safety and biomarker analyses of tumor mutational burden (TMB), PD-L1, and previously identified mutational signatures.

resultsOf 270 treated patients, 139 had evaluable TMB. With 33.7 months' minimum follow-up, ORR per BIRC, median PFS, and median OS [95% confidence interval (CI)] in all treated patients were 20.7% (16.1-26.1), 1.9 months (1.9-2.3), and 8.6 months (6.1-11.3), respectively. No new safety signals were identified. Higher TMB was associated (

conclusionsThese results support the durable antitumor activity of nivolumab and suggest that TMB may enrich for better response in mUC. Future studies of TMB/PD-L1 as biomarkers for response to nivolumab in randomized trials are warranted.

Indexed as

AgedAged, 80 and overAntibodies, Monoclonal, HumanizedB7-H1 AntigenBiomarkers, TumorCarcinoma, Transitional CellFemaleGene Expression Regulation, NeoplasticHumansMaleMiddle AgedMutationNeoplasm MetastasisNivolumabPlatinumProgression-Free SurvivalAntibodies, Monoclonal, HumanizedB7-H1 AntigenBiomarkers, TumorNivolumabPlatinum

Identifiers

PMID32532789
PMCPMC8166422
OpenAlexW3034884095

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.