Evidence map›Paper›PMID 41627171›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2026

Neoadjuvant Nivolumab with or without Ipilimumab for Cisplatin-Ineligible Patients with Muscle-Invasive Bladder Cancer.

Brendan J Guercio, Eugene J Pietzak, Vignesh Ravichandran, Jie-Fu Chen, Ronak H Shah, Vanessa Peters, Ashley M Regazzi, Scot A Niglio, David H Aggen, Samuel A Funt and 15 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Brendan J GuercioGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0001-6296-2473
Eugene J PietzakUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-5121-5701
Vignesh RavichandranMarie-Josée and Henry R. Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-1532-2593
Jie-Fu ChenDepartment of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-4036-6969
Ronak H ShahHuman Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0001-9042-6213
Vanessa PetersGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0009-0004-9645-5954
Ashley M RegazziGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-6019-1852
Scot A NiglioGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-1421-1533
David H AggenGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0003-3963-5751
Samuel A FuntGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-7235-6319
Timothy F DonahueUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-0932-2968
Alvin C GohUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0003-3092-9024
Eugene K ChaUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-8807-2353
Phillip WongImmune Monitoring Core Facility, Ludwig Center for Cancer Immunotherapy, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-6360-849X
Allison L RichardsMarie-Josée and Henry R. Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0003-2312-2302
Cassidy C CobbsIntegrated Genomics Operation, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0003-4465-8894
S Machele DonatUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0001-7430-9236
Guido DalbagniUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0009-0002-2973-8159
Bernard H BochnerUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0003-0846-0848
Gopa IyerGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-5093-6099
Mark T A DonoghueMarie-Josée and Henry R. Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0003-4538-6069
Irina OstrovnayaDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0003-1783-0070
Hikmat A Al-AhmadieDepartment of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-2938-6627
Jonathan E RosenbergGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0003-2637-4249
Min Yuen TeoGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0003-2511-6731

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Investigational Cancer Therapeutics Training Program (ICTTP)T32CA009207 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Omar Abdel-Wahab, Alexander Drilon · 1985 to 2026
$13.7M
University of Rochester Wilmot Cancer Institute Support GrantP30CA272302 · NCI · UNIVERSITY OF ROCHESTER · PI JONATHAN W FRIEDBERG · 2025 to 2026
$6.4M
Bladder Cancer Advocacy Network (BCAN) Young Investigator AwardBristol-Myers Squibb (BMS)Conquer Cancer Foundation (CCF) Career Development AwardConquer Cancer Foundation (CCF) Young Investigator AwardNational Cancer Institute (NCI) P30-CA008748National Cancer Institute (NCI) P30CA272302National Cancer Institute (NCI) T32-CA009207NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA272302NCI NIH HHS T32 CA009207
6 · The paper itself

Abstract

purposeMany patients with muscle-invasive bladder cancer (MIBC) are ineligible for cisplatin-based therapy. We conducted a phase II trial of neoadjuvant nivolumab ± ipilimumab for cisplatin-ineligible patients. PATIENTS AND

methodsPatients with MIBC were enrolled in two consecutive cohorts: (i) nivolumab alone and (ii) ipilimumab/nivolumab. A third cohort with alternative dosing was planned. The primary endpoint was eligibility for cystectomy ≤60 days after last treatment. Correlative analyses were performed, with the PURE-01 trial used as an independent dataset.

resultsFifteen patients enrolled onto each cohort. In cohorts 1 and 2, 12 of 15 and eight of 15 were eligible for cystectomy within 60 days, respectively. Due to cohort 2's failure to meet the primary endpoint, cohort 3 was not initiated. With nivolumab alone, four patients achieved <ypT2ypN0 (26%), with two pathologic complete responses (pCR; 13%). With ipilimumab/nivolumab, three achieved <ypT2ypN0 (20%), with one pCR (7%). One patient after nivolumab and two after ipilimumab/nivolumab had durable clinical complete responses (CR) without cystectomy. Twelve-month recurrence-free survival (RFS) was 79% with nivolumab [95% confidence interval (CI), 61-100] and 61% with ipilimumab/nivolumab (95% CI, 39-95). Sequencing analyses suggest that NCOR1 alterations may be associated with improved clinical outcomes. Gene expression profiling indicated a potential association between tumor-infiltrating immune cells and longer RFS (log-rank P = 0.18); this was also observed in PURE-01 (P = 0.022).

conclusionsAmong cisplatin-ineligible patients with MIBC, nivolumab alone was well tolerated. Ipilimumab/nivolumab caused toxicity that delayed cystectomy. Cases of progression before cystectomy indicated insufficient efficacy of pure neoadjuvant immunotherapy for unselected patients. Despite low response rates, some patients experienced sustained clinical CR without cystectomy.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsNeoadjuvant TherapyUrinary Bladder NeoplasmsAgedAged, 80 and overCisplatinCystectomyFemaleHumansIpilimumabMaleMiddle AgedNeoplasm InvasivenessNivolumabPathologic Complete ResponseTreatment OutcomeCisplatinIpilimumabNivolumab

Identifiers

PMID41627171
PMCPMC12967298

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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.