Prospective Translational Study Investigating Predictors of Outcome in Metastatic Renal Cell Carcinoma Patients Treated With Nivolumab (I-Rene Trial) (I-Rene)
12. maj 2021 opdateret af: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Prospective translational study investigating predictors of outcome in metastatic renal cell carcinoma patients treated with Nivolumab (I-Rene trial)
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
Prospective translational study investigating predictors of outcome in metastatic renal cell carcinoma patients treated with Nivolumab (I-Rene trial)
Undersøgelsestype
Observationel
Tilmelding (Forventet)
90
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Rosanna Montone, Dr.ssa
- Telefonnummer: +390223903817
- E-mail: rosanna.montone@istitutotumori.mi.it
Undersøgelse Kontakt Backup
- Navn: ELENA VERZONI, MD
- Telefonnummer: +390223904449
- E-mail: elena.Verzoni@istitutotumori.mi.it
Studiesteder
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-
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Milano, Italien, 20133
- Rekruttering
- Fondazione IRCCS Istituto Nazionale Tumori
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Kontakt:
- Rosanna Montone, Dr.ssa
- Telefonnummer: +390223903817
- E-mail: rosanna.montone@istitutotumori.mi.it
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Kontakt:
- ELENA VERZONI, MD
- Telefonnummer: +390223904449
- E-mail: elena.Verzoni@istitutotumori.mi.it
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Ledende efterforsker:
- Giuseppe Procopio, MD
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Underforsker:
- Elena Verzoni, Dr.ssa
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
metastatic renal cell carcinoma
Beskrivelse
Inclusion Criteria:
- Written informed consent
- metastatic renal cell carcinoma (a clear-cell/ not clear-cell)
- Progression to previous treatment with tyrosine kinase inhibitors
- Patients candidates for II-line therapy with Nivolumab (or tyrosine kinase inhibitors-in the control arm)
Exclusion Criteria:
none
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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patients treated with nivolumab
Patients candidates for II line therapy with Nivolumab from clinical practice
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patients treated with TKI
Patients candidates for II line therapy with TKI from clinical practice
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Investigate the predictive role of circulating miRNAs will be studied with OpenArray technology (OA, Thermo Fisher)
Tidsramme: 36 months
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To investigate the predictive role of circulating miRNAs in patients who respond to nivolumab versus those who do not respond before treatment, after two infusions (4 weeks), at the first radiological re-evaluation (12 weeks) and at the time of disease progression.
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36 months
|
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To evaluate whether the immunological profile of tumor tissue or circulating tumor cells Using Multiplexed Biomarker Imaging (MBI), multiparametric flow cytometry
Tidsramme: 36 months
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To evaluate whether the immunological profile of tumor tissue or circulating tumor cells may be a potential predictor of clinical response in patients treated with nivolumab.
Using Multiplexed Biomarker Imaging (MBI), multiparametric flow cytometry
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36 months
|
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Characterize alterations in genes and signal transmission pathways. Using Next Generation Sequencing, NGS)
Tidsramme: 36 months
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o characterize alterations in genes and signaling pathways and to identify mutational burden differences between tumors of patients with metastatic renal cell carcinoma who respond or not to nivolumab.
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36 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Giuseppe Procopio, MD, Fondazione IRCCS Istituto Nazionale Tumori Milano
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- Rosenberg JE, Hoffman-Censits J, Powles T, van der Heijden MS, Balar AV, Necchi A, Dawson N, O'Donnell PH, Balmanoukian A, Loriot Y, Srinivas S, Retz MM, Grivas P, Joseph RW, Galsky MD, Fleming MT, Petrylak DP, Perez-Gracia JL, Burris HA, Castellano D, Canil C, Bellmunt J, Bajorin D, Nickles D, Bourgon R, Frampton GM, Cui N, Mariathasan S, Abidoye O, Fine GD, Dreicer R. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet. 2016 May 7;387(10031):1909-20. doi: 10.1016/S0140-6736(16)00561-4. Epub 2016 Mar 4.
- Gabrilovich DI, Ostrand-Rosenberg S, Bronte V. Coordinated regulation of myeloid cells by tumours. Nat Rev Immunol. 2012 Mar 22;12(4):253-68. doi: 10.1038/nri3175.
- Filipazzi P, Valenti R, Huber V, Pilla L, Canese P, Iero M, Castelli C, Mariani L, Parmiani G, Rivoltini L. Identification of a new subset of myeloid suppressor cells in peripheral blood of melanoma patients with modulation by a granulocyte-macrophage colony-stimulation factor-based antitumor vaccine. J Clin Oncol. 2007 Jun 20;25(18):2546-53. doi: 10.1200/JCO.2006.08.5829.
- Cancer Genome Atlas Research Network. Comprehensive molecular characterization of clear cell renal cell carcinoma. Nature. 2013 Jul 4;499(7456):43-9. doi: 10.1038/nature12222. Epub 2013 Jun 23.
- Hakimi AA, Ostrovnaya I, Reva B, Schultz N, Chen YB, Gonen M, Liu H, Takeda S, Voss MH, Tickoo SK, Reuter VE, Russo P, Cheng EH, Sander C, Motzer RJ, Hsieh JJ; ccRCC Cancer Genome Atlas (KIRC TCGA) Research Network investigators. Adverse outcomes in clear cell renal cell carcinoma with mutations of 3p21 epigenetic regulators BAP1 and SETD2: a report by MSKCC and the KIRC TCGA research network. Clin Cancer Res. 2013 Jun 15;19(12):3259-67. doi: 10.1158/1078-0432.CCR-12-3886. Epub 2013 Apr 25.
- Pena-Llopis S, Vega-Rubin-de-Celis S, Liao A, Leng N, Pavia-Jimenez A, Wang S, Yamasaki T, Zhrebker L, Sivanand S, Spence P, Kinch L, Hambuch T, Jain S, Lotan Y, Margulis V, Sagalowsky AI, Summerour PB, Kabbani W, Wong SW, Grishin N, Laurent M, Xie XJ, Haudenschild CD, Ross MT, Bentley DR, Kapur P, Brugarolas J. BAP1 loss defines a new class of renal cell carcinoma. Nat Genet. 2012 Jun 10;44(7):751-9. doi: 10.1038/ng.2323. Erratum In: Nat Genet. 2012 Sep;44(9):1072.
- Brooks SA, Brannon AR, Parker JS, Fisher JC, Sen O, Kattan MW, Hakimi AA, Hsieh JJ, Choueiri TK, Tamboli P, Maranchie JK, Hinds P, Miller CR, Nielsen ME, Rathmell WK. ClearCode34: A prognostic risk predictor for localized clear cell renal cell carcinoma. Eur Urol. 2014 Jul;66(1):77-84. doi: 10.1016/j.eururo.2014.02.035. Epub 2014 Feb 25.
- Gerlinger M, Horswell S, Larkin J, Rowan AJ, Salm MP, Varela I, Fisher R, McGranahan N, Matthews N, Santos CR, Martinez P, Phillimore B, Begum S, Rabinowitz A, Spencer-Dene B, Gulati S, Bates PA, Stamp G, Pickering L, Gore M, Nicol DL, Hazell S, Futreal PA, Stewart A, Swanton C. Genomic architecture and evolution of clear cell renal cell carcinomas defined by multiregion sequencing. Nat Genet. 2014 Mar;46(3):225-233. doi: 10.1038/ng.2891. Epub 2014 Feb 2.
- Walter S, Weinschenk T, Stenzl A, Zdrojowy R, Pluzanska A, Szczylik C, Staehler M, Brugger W, Dietrich PY, Mendrzyk R, Hilf N, Schoor O, Fritsche J, Mahr A, Maurer D, Vass V, Trautwein C, Lewandrowski P, Flohr C, Pohla H, Stanczak JJ, Bronte V, Mandruzzato S, Biedermann T, Pawelec G, Derhovanessian E, Yamagishi H, Miki T, Hongo F, Takaha N, Hirakawa K, Tanaka H, Stevanovic S, Frisch J, Mayer-Mokler A, Kirner A, Rammensee HG, Reinhardt C, Singh-Jasuja H. Multipeptide immune response to cancer vaccine IMA901 after single-dose cyclophosphamide associates with longer patient survival. Nat Med. 2012 Aug;18(8):1254-61. doi: 10.1038/nm.2883. Epub 2012 Jul 29.
- Verderio P, Bottelli S, Ciniselli CM, Pierotti MA, Gariboldi M, Pizzamiglio S. NqA: an R-based algorithm for the normalization and analysis of microRNA quantitative real-time polymerase chain reaction data. Anal Biochem. 2014 Sep 15;461:7-9. doi: 10.1016/j.ab.2014.05.020. Epub 2014 Jun 2.
- Verderio P, Bottelli S, Pizzamiglio S, Ciniselli CM. Developing miRNA signatures: a multivariate prospective. Br J Cancer. 2016 Jun 28;115(1):1-4. doi: 10.1038/bjc.2016.164. No abstract available.
- Zhou L, Liu XD, Sun M, Zhang X, German P, Bai S, Ding Z, Tannir N, Wood CG, Matin SF, Karam JA, Tamboli P, Sircar K, Rao P, Rankin EB, Laird DA, Hoang AG, Walker CL, Giaccia AJ, Jonasch E. Targeting MET and AXL overcomes resistance to sunitinib therapy in renal cell carcinoma. Oncogene. 2016 May;35(21):2687-97. doi: 10.1038/onc.2015.343. Epub 2015 Sep 14.
- Geissler K, Fornara P, Lautenschlager C, Holzhausen HJ, Seliger B, Riemann D. Immune signature of tumor infiltrating immune cells in renal cancer. Oncoimmunology. 2015 Feb 3;4(1):e985082. doi: 10.4161/2162402X.2014.985082. eCollection 2015 Jan.
- Gebhardt C, Sevko A, Jiang H, Lichtenberger R, Reith M, Tarnanidis K, Holland-Letz T, Umansky L, Beckhove P, Sucker A, Schadendorf D, Utikal J, Umansky V. Myeloid Cells and Related Chronic Inflammatory Factors as Novel Predictive Markers in Melanoma Treatment with Ipilimumab. Clin Cancer Res. 2015 Dec 15;21(24):5453-9. doi: 10.1158/1078-0432.CCR-15-0676. Epub 2015 Aug 19.
- Hammers HJ, Plimack ER, Infante JR, Rini BI, McDermott DF, Lewis LD, Voss MH, Sharma P, Pal SK, Razak ARA, Kollmannsberger C, Heng DYC, Spratlin J, McHenry MB, Amin A. Safety and Efficacy of Nivolumab in Combination With Ipilimumab in Metastatic Renal Cell Carcinoma: The CheckMate 016 Study. J Clin Oncol. 2017 Dec 1;35(34):3851-3858. doi: 10.1200/JCO.2016.72.1985. Epub 2017 Jul 5.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
29. november 2018
Primær færdiggørelse (Forventet)
29. november 2021
Studieafslutning (Forventet)
29. november 2021
Datoer for studieregistrering
Først indsendt
7. maj 2021
Først indsendt, der opfyldte QC-kriterier
12. maj 2021
Først opslået (Faktiske)
18. maj 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. maj 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. maj 2021
Sidst verificeret
1. maj 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- INT 71/18
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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