Prospective Translational Study Investigating Predictors of Outcome in Metastatic Renal Cell Carcinoma Patients Treated With Nivolumab (I-Rene Trial)

NCT ID: NCT04891055

Last Updated: 2021-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-29
• Study Completion Date: 2021-11-29

Brief Summary

Prospective translational study investigating predictors of outcome in metastatic renal cell carcinoma patients treated with Nivolumab (I-Rene trial)

Detailed Description

Prospective translational study investigating predictors of outcome in metastatic renal cell carcinoma patients treated with Nivolumab (I-Rene trial)

Conditions

Metastatic Renal Cell Carcinoma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

patients treated with nivolumab

Patients candidates for II line therapy with Nivolumab from clinical practice

No interventions assigned to this group

patients treated with TKI

Patients candidates for II line therapy with TKI from clinical practice

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministero della Salute, Italy

OTHER

Sponsor Role: collaborator

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Procopio, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Istituto Nazionale Tumori Milano

Locations

Fondazione IRCCS Istituto Nazionale Tumori

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Elena Verzoni, MD

Role: CONTACT

elena.verzoni@istitutotumori.mi.it

+390223904449

Rosanna Montone, Dr.ssa

Role: CONTACT

rosanna.montone@istitutotumori.mi.it

+390223903817

Facility Contacts

Elena Verzoni, MD

Role: primary

elena.verzoni@istitutotumori.mi.it

+390223904449

Rosanna Montone, Dr.ssa

Role: backup

rosanna.montone@istitutotumori.mi.it

+390223903817

References

Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Choueiri TK, Gurney H, Donskov F, Bono P, Wagstaff J, Gauler TC, Ueda T, Tomita Y, Schutz FA, Kollmannsberger C, Larkin J, Ravaud A, Simon JS, Xu LA, Waxman IM, Sharma P; CheckMate 025 Investigators. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1803-13. doi: 10.1056/NEJMoa1510665. Epub 2015 Sep 25.

Reference Type: BACKGROUND

PMID: 26406148 (View on PubMed)

Rizvi NA, Hellmann MD, Snyder A, Kvistborg P, Makarov V, Havel JJ, Lee W, Yuan J, Wong P, Ho TS, Miller ML, Rekhtman N, Moreira AL, Ibrahim F, Bruggeman C, Gasmi B, Zappasodi R, Maeda Y, Sander C, Garon EB, Merghoub T, Wolchok JD, Schumacher TN, Chan TA. Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science. 2015 Apr 3;348(6230):124-8. doi: 10.1126/science.aaa1348. Epub 2015 Mar 12.

Reference Type: BACKGROUND

PMID: 25765070 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23792563 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23620406 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22683710 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24613583 (View on PubMed)

Tumeh PC, Harview CL, Yearley JH, Shintaku IP, Taylor EJ, Robert L, Chmielowski B, Spasic M, Henry G, Ciobanu V, West AN, Carmona M, Kivork C, Seja E, Cherry G, Gutierrez AJ, Grogan TR, Mateus C, Tomasic G, Glaspy JA, Emerson RO, Robins H, Pierce RH, Elashoff DA, Robert C, Ribas A. PD-1 blockade induces responses by inhibiting adaptive immune resistance. Nature. 2014 Nov 27;515(7528):568-71. doi: 10.1038/nature13954.

Reference Type: BACKGROUND

PMID: 25428505 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26952546 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24487277 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17577033 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22842478 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24892985 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27351381 (View on PubMed)

Hugo W, Zaretsky JM, Sun L, Song C, Moreno BH, Hu-Lieskovan S, Berent-Maoz B, Pang J, Chmielowski B, Cherry G, Seja E, Lomeli S, Kong X, Kelley MC, Sosman JA, Johnson DB, Ribas A, Lo RS. Genomic and Transcriptomic Features of Response to Anti-PD-1 Therapy in Metastatic Melanoma. Cell. 2016 Mar 24;165(1):35-44. doi: 10.1016/j.cell.2016.02.065. Epub 2016 Mar 17.

Reference Type: BACKGROUND

PMID: 26997480 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26364599 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22437938 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25949868 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26289067 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28678668 (View on PubMed)

Other Identifiers

INT 71/18

Identifier Type: -

Identifier Source: org_study_id