{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,29]],"date-time":"2026-06-29T09:45:51Z","timestamp":1782726351611,"version":"3.54.5"},"reference-count":30,"publisher":"MDPI AG","issue":"13","license":[{"start":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T00:00:00Z","timestamp":1782432000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Bristol Myers Squibb"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Background\/Objectives: Nivolumab monotherapy is a standard of care in previously treated advanced renal cell carcinoma (aRCC) and was approved based on the results of the randomized clinical trial Checkmate-025. The non-interventional study (NIS) NORA collected data on the effectiveness and safety of nivolumab monotherapy in real-world clinical routine. Its final, long-term follow-up data are presented here. Methods: NORA was a prospective, multicentre NIS recruiting at 54 German sites, evaluating the effectiveness and safety of nivolumab monotherapy in pre-treated patients with aRCC. Endpoints included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), safety, and patient-reported outcomes (PROs). Results: A total of 232 patients were eligible. Of the patients, 15% had favourable, 58% had intermediate, and 15% had poor risk according to the International Metastatic RCC Database Consortium. Of the patients, 77% received nivolumab as second-line, 15% as third-line, and 8% as \u2265fourth-line therapy. With a median long-term follow-up of 76 months (minimum 62 months), median OS was 22.2 months (95% confidence interval [CI] 16.5\u201325.9) and median PFS was 4.1 months (95% CI 3.2\u20135.4). The ORR was 21% with a median DOR of 27.9 months (95% CI 15.9\u2014not evaluable). Of the patients, 47% and 16% had treatment-related adverse events of all grades and of grades 3\u20134, respectively. One patient died from autoimmune hepatitis related to treatment. PROs did not reveal any new signals. Conclusions: The long-term follow-up of NORA confirms that nivolumab monotherapy is an effective and safe therapy in patients with aRCC after prior therapy. With comparable follow-up times, our real-world data were not substantially different from the final long-term results of the pivotal Checkmate-025 study.<\/jats:p>","DOI":"10.3390\/cancers18132075","type":"journal-article","created":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T08:43:57Z","timestamp":1782463437000},"page":"2075","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Real-World Data on the Use of Nivolumab Monotherapy in the Treatment of Advanced Renal Cell Carcinoma After Prior Therapy: Final Results from the Non-Interventional NORA Study"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3084-8654","authenticated-orcid":false,"given":"Marc-Oliver","family":"Grimm","sequence":"first","affiliation":[{"name":"Department of Urology, Jena University Hospital, Friedrich-Schiller University Jena, 07747 Jena, Germany"},{"name":"Comprehensive Cancer Center Germany (CCCG), 07747 Jena, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2083-7687","authenticated-orcid":false,"given":"Viktor","family":"Gr\u00fcnwald","sequence":"additional","affiliation":[{"name":"Clinic for Medical Oncology and Clinic for Urology, West-German Cancer Center Essen, Essen University Hospital, 45147 Essen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harald","family":"M\u00fcller-Huesmann","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Hematology and Oncology, St Josef Brothers Hospital, 33098 Paderborn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2862-7302","authenticated-orcid":false,"given":"Philipp","family":"Ivanyi","sequence":"additional","affiliation":[{"name":"Clinic Department of for Hematology, Hemostaseology, Oncology and Stem Cell Transplantation, Interdisciplinary Oncologic Outpatient Clinic (OIA), Hannover Medical School, 30625 Hannover, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8717-2096","authenticated-orcid":false,"given":"Martin","family":"Schostak","sequence":"additional","affiliation":[{"name":"LOGICURO GmbH, 14482 Potsdam-Babelsberg, Germany"},{"name":"Department of Urology, Urooncology, Robot-Assisted and Focal Therapy, Magdeburg University Hospital, 39120 Magdeburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eyck","family":"von der Heyde","sequence":"additional","affiliation":[{"name":"Practice for Oncology Raschplatz, 30161 Hannover, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wolfgang","family":"Schultze-Seemann","sequence":"additional","affiliation":[{"name":"Department of Urology, Freiburg University Hospital, 79106 Freiburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Holger","family":"Schulz","sequence":"additional","affiliation":[{"name":"Practice for Medical Oncology and Hematology, 50226 Frechen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2569-4446","authenticated-orcid":false,"given":"Martin","family":"B\u00f6gemann","sequence":"additional","affiliation":[{"name":"Department of Urology, M\u00fcnster University Hospital, 48149 M\u00fcnster, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan Wolfgang","family":"Gr\u00f6tzinger","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Germany, 80636 Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2184-1234","authenticated-orcid":false,"given":"Luis","family":"Vaz","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb UK, Uxbridge UB11 1AF, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Herber","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Germany, 80636 Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jens","family":"Bedke","sequence":"additional","affiliation":[{"name":"Department of Urology and Transplant Surgery, Stuttgart Hospital, 70174 Stuttgart, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,6,26]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"146","DOI":"10.1186\/s12943-024-02059-y","article-title":"PD1\/PD-L1 blockade in clear cell renal cell carcinoma: Mechanistic insights, clinical efficacy, and future perspectives","volume":"23","author":"Zhu","year":"2024","journal-title":"Mol. 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