000306673 001__ 306673 000306673 005__ 20260303120958.0 000306673 0247_ $$2doi$$a10.1002/ijc.70267 000306673 0247_ $$2pmid$$apmid:41317031 000306673 0247_ $$2ISSN$$a0020-7136 000306673 0247_ $$2ISSN$$a1097-0215 000306673 037__ $$aDKFZ-2025-02666 000306673 041__ $$aEnglish 000306673 082__ $$a610 000306673 1001_ $$00000-0001-7264-6335$$aDinkel, Hendrik$$b0 000306673 245__ $$aReal-world efficacy and toxicity of ipilimumab and nivolumab as a first-line treatment for advanced renal cell carcinoma according to IMDC risk criteria-A multi-center retrospective analysis on behalf of the GUARDIANS group. 000306673 260__ $$aBognor Regis$$bWiley-Liss$$c2025 000306673 3367_ $$2DRIVER$$aarticle 000306673 3367_ $$2DataCite$$aOutput Types/Journal article 000306673 3367_ $$0PUB:(DE-HGF)16$$2PUB:(DE-HGF)$$aJournal Article$$bjournal$$mjournal$$s1764600535_815121 000306673 3367_ $$2BibTeX$$aARTICLE 000306673 3367_ $$2ORCID$$aJOURNAL_ARTICLE 000306673 3367_ $$00$$2EndNote$$aJournal Article 000306673 500__ $$aepub 000306673 520__ $$aIpilimumab and nivolumab are recommended as first-line therapy for patients with metastatic or advanced renal cell carcinoma (aRCC) and International Metastatic RCC Database Consortium (IMDC) intermediate or poor risk. We retrospectively evaluated efficacy and safety in a multi-center real-world cohort with 356 patients initiating ipilimumab and nivolumab from 17 centers in Germany and Switzerland. Median age was 64 years, most patients were male (69.1%) and had clear cell histology (74.1%). IMDC risk was intermediate in 61.8% and poor in 28.7%. About 37.1% of cases did not meet the inclusion criteria for the CheckMate 214 pivotal study (e.g., poor Eastern Cooperative Oncology Group [Performance Status Scale] [ECOG] status, comorbidities, brain metastases, and impaired renal function). After a median follow-up of 17.5 months, complete response was seen in 8.7%, partial response in 28.7% of patients. Median progression-free survival (PFS) was 8 (95% confidence interval [CI] 5.4-10.6) and median overall survival (OS) 39 months (95% CI 27.5-50.5). Subgroup analysis of patients with non-clear cell histology showed a shorter PFS and OS. Other negative predictors were poor ECOG, fewer induction cycles, ineligibility to pivotal study, and hepatic metastases. Adverse events occurred in 76.4% of patients (35.4% ≥ grade 3). High-dose corticosteroids were applied in 27.3% of cases. Cabozantinib was most frequently administered (63.4%) as subsequent therapy and showed superior OS and PFS compared to other second-line options. Our data support ipilimumab and nivolumab as a first-line treatment of aRCC with robust efficacy and safety. Patient selection was less restrictive in our clinical practice and may explain differences to CheckMate 214 trial. 000306673 536__ $$0G:(DE-HGF)POF4-899$$a899 - ohne Topic (POF4-899)$$cPOF4-899$$fPOF IV$$x0 000306673 588__ $$aDataset connected to CrossRef, PubMed, , Journals: inrepo02.dkfz.de 000306673 650_7 $$2Other$$aimmunotherapy 000306673 650_7 $$2Other$$aipilimumab 000306673 650_7 $$2Other$$anivolumab 000306673 650_7 $$2Other$$areal‐world 000306673 650_7 $$2Other$$arenal cell carcinoma 000306673 7001_ $$aMaterna, Linus$$b1 000306673 7001_ $$00000-0002-2083-5561$$aStelmach, Ramona$$b2 000306673 7001_ $$aZschäbitz, Stefanie$$b3 000306673 7001_ $$aNeuberger, Stephanie$$b4 000306673 7001_ $$aAydogdu, Can D$$b5 000306673 7001_ $$aCasuscelli, Jozefina$$b6 000306673 7001_ $$aEgenolf, Timo$$b7 000306673 7001_ $$aSilberg, Matteo$$b8 000306673 7001_ $$aSteinestel, Julie$$b9 000306673 7001_ $$aStrauss, Arne$$b10 000306673 7001_ $$aKirchhoff, Florian$$b11 000306673 7001_ $$aAhrens, Marit$$b12 000306673 7001_ $$aPaffenholz, Pia$$b13 000306673 7001_ $$aCathomas, Richard$$b14 000306673 7001_ $$aÖzdemir, Berna C$$b15 000306673 7001_ $$aGossler, Christopher$$b16 000306673 7001_ $$aIvanyi, Philipp$$b17 000306673 7001_ $$aRehlinghaus, Marc$$b18 000306673 7001_ $$0P:(DE-HGF)0$$aHilser, Thomas$$b19 000306673 7001_ $$0P:(DE-HGF)0$$aGrünwald, Viktor$$b20 000306673 7001_ $$aSchlack, Katrin$$b21 000306673 773__ $$0PERI:(DE-600)1474822-8$$a10.1002/ijc.70267$$gp. ijc.70267$$pnn$$tInternational journal of cancer$$vnn$$x0020-7136$$y2025 000306673 8564_ $$uhttps://inrepo02.dkfz.de/record/306673/files/Intl%20Journal%20of%20Cancer%20-%202025%20-%20Dinkel%20-%20Real%E2%80%90world%20efficacy%20and%20toxicity%20of%20ipilimumab%20and%20nivolumab%20as%20a%20first%E2%80%90line-1.pdf$$yOpenAccess 000306673 8564_ $$uhttps://inrepo02.dkfz.de/record/306673/files/Intl%20Journal%20of%20Cancer%20-%202025%20-%20Dinkel%20-%20Real%E2%80%90world%20efficacy%20and%20toxicity%20of%20ipilimumab%20and%20nivolumab%20as%20a%20first%E2%80%90line-1.pdf?subformat=pdfa$$xpdfa$$yOpenAccess 000306673 909CO $$ooai:inrepo02.dkfz.de:306673$$popenaire$$popen_access$$pVDB$$pdriver$$pdnbdelivery 000306673 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-HGF)0$$aDeutsches Krebsforschungszentrum$$b19$$kDKFZ 000306673 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-HGF)0$$aDeutsches Krebsforschungszentrum$$b20$$kDKFZ 000306673 9131_ $$0G:(DE-HGF)POF4-899$$1G:(DE-HGF)POF4-890$$2G:(DE-HGF)POF4-800$$3G:(DE-HGF)POF4$$4G:(DE-HGF)POF$$aDE-HGF$$bProgrammungebundene Forschung$$lohne Programm$$vohne Topic$$x0 000306673 9141_ $$y2025 000306673 915__ $$0StatID:(DE-HGF)0200$$2StatID$$aDBCoverage$$bSCOPUS$$d2024-12-17 000306673 915__ $$0StatID:(DE-HGF)0160$$2StatID$$aDBCoverage$$bEssential Science Indicators$$d2024-12-17 000306673 915__ $$0StatID:(DE-HGF)1050$$2StatID$$aDBCoverage$$bBIOSIS Previews$$d2024-12-17 000306673 915__ $$0StatID:(DE-HGF)1190$$2StatID$$aDBCoverage$$bBiological Abstracts$$d2024-12-17 000306673 915__ $$0StatID:(DE-HGF)0100$$2StatID$$aJCR$$bINT J CANCER : 2022$$d2024-12-17 000306673 915__ $$0StatID:(DE-HGF)3001$$2StatID$$aDEAL Wiley$$d2024-12-17$$wger 000306673 915__ $$0StatID:(DE-HGF)1030$$2StatID$$aDBCoverage$$bCurrent Contents - Life Sciences$$d2024-12-17 000306673 915__ $$0StatID:(DE-HGF)0113$$2StatID$$aWoS$$bScience Citation Index Expanded$$d2024-12-17 000306673 915__ $$0StatID:(DE-HGF)0150$$2StatID$$aDBCoverage$$bWeb of Science Core Collection$$d2024-12-17 000306673 915__ $$0StatID:(DE-HGF)0510$$2StatID$$aOpenAccess 000306673 915__ $$0StatID:(DE-HGF)9905$$2StatID$$aIF >= 5$$bINT J CANCER : 2022$$d2024-12-17 000306673 915__ $$0StatID:(DE-HGF)0300$$2StatID$$aDBCoverage$$bMedline$$d2024-12-17 000306673 915__ $$0StatID:(DE-HGF)0420$$2StatID$$aNationallizenz$$d2024-12-17$$wger 000306673 915__ $$0StatID:(DE-HGF)0199$$2StatID$$aDBCoverage$$bClarivate Analytics Master Journal List$$d2024-12-17 000306673 9201_ $$0I:(DE-He78)ED01-20160331$$kED01$$lDKTK Koordinierungsstelle Essen/Düsseldorf$$x0 000306673 980__ $$ajournal 000306673 980__ $$aVDB 000306673 980__ $$aUNRESTRICTED 000306673 980__ $$aI:(DE-He78)ED01-20160331 000306673 9801_ $$aFullTexts