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Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Preliminary discovery

Commentary in our index that names this trial so far

Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.

ChannelFound
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The trial

ClinicalTrials.gov
Official title
Activity of Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma
Phase
Phase 2
Status
Recruiting
Conditions
Bellini Carcinoma; Collecting Duct Carcinoma; Renal Medullary Carcinoma
Interventions
Pembrolizumab + Enfortumab Vedotin
Arms
  • Pembrolizumab + Enfortumab Vedotin · Experimental
Enrollment
23 (estimated)
Primary outcomes
  • ORR in patients treated with Pembrolizumab plus Enfortumab Vedotin
Sponsor
Giuseppe Procopio
Start
May 30, 2025
Primary completion
Oct 2027 (estimated)
Results posted
No
Registry record
NCT06302569 · updated Sep 9, 2025

Publications

linked from the registry
  • Procopio G, Sepe P, Claps M, Buti S, Colecchia M, Giannatempo P, Guadalupi V, Mariani L, Lalli L, Fuca G, de Braud F, Verzoni E. Cabozantinib as First-line Treatment in Patients With Metastatic Collecting Duct Renal Cell Carcinoma: Results of the BONSAI Trial for the Italian Network for Research in Urologic-Oncology (Meet-URO 2 Study). JAMA Oncol. 2022 Jun 1;8(6):910-913. doi: 10.1001/jamaoncol.2022.0238. PubMed 35420628
  • Oudard S, Banu E, Vieillefond A, Fournier L, Priou F, Medioni J, Banu A, Duclos B, Rolland F, Escudier B, Arakelyan N, Culine S; GETUG (Groupe d'Etudes des Tumeurs Uro-Genitales). Prospective multicenter phase II study of gemcitabine plus platinum salt for metastatic collecting duct carcinoma: results of a GETUG (Groupe d'Etudes des Tumeurs Uro-Genitales) study. J Urol. 2007 May;177(5):1698-702. doi: 10.1016/j.juro.2007.01.063. PubMed 17437788
  • Pagani F, Colecchia M, Sepe P, Apollonio G, Claps M, Verzoni E, de Braud F, Procopio G. Collecting ducts carcinoma: An orphan disease. Literature overview and future perspectives. Cancer Treat Rev. 2019 Sep;79:101891. doi: 10.1016/j.ctrv.2019.101891. Epub 2019 Aug 27. PubMed 31491662
  • Challita-Eid PM, Satpayev D, Yang P, An Z, Morrison K, Shostak Y, Raitano A, Nadell R, Liu W, Lortie DR, Capo L, Verlinsky A, Leavitt M, Malik F, Avina H, Guevara CI, Dinh N, Karki S, Anand BS, Pereira DS, Joseph IB, Donate F, Morrison K, Stover DR. Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models. Cancer Res. 2016 May 15;76(10):3003-13. doi: 10.1158/0008-5472.CAN-15-1313. Epub 2016 Mar 24. PubMed 27013195
  • Disis ML. Immune regulation of cancer. J Clin Oncol. 2010 Oct 10;28(29):4531-8. doi: 10.1200/JCO.2009.27.2146. Epub 2010 Jun 1. PubMed 20516428
  • Dudley ME, Wunderlich JR, Yang JC, Sherry RM, Topalian SL, Restifo NP, Royal RE, Kammula U, White DE, Mavroukakis SA, Rogers LJ, Gracia GJ, Jones SA, Mangiameli DP, Pelletier MM, Gea-Banacloche J, Robinson MR, Berman DM, Filie AC, Abati A, Rosenberg SA. Adoptive cell transfer therapy following non-myeloablative but lymphodepleting chemotherapy for the treatment of patients with refractory metastatic melanoma. J Clin Oncol. 2005 Apr 1;23(10):2346-57. doi: 10.1200/JCO.2005.00.240. PubMed 15800326
  • Hunder NN, Wallen H, Cao J, Hendricks DW, Reilly JZ, Rodmyre R, Jungbluth A, Gnjatic S, Thompson JA, Yee C. Treatment of metastatic melanoma with autologous CD4+ T cells against NY-ESO-1. N Engl J Med. 2008 Jun 19;358(25):2698-703. doi: 10.1056/NEJMoa0800251. PubMed 18565862
  • Greenwald RJ, Freeman GJ, Sharpe AH. The B7 family revisited. Annu Rev Immunol. 2005;23:515-48. doi: 10.1146/annurev.immunol.23.021704.115611. PubMed 15771580
  • Okazaki T, Maeda A, Nishimura H, Kurosaki T, Honjo T. PD-1 immunoreceptor inhibits B cell receptor-mediated signaling by recruiting src homology 2-domain-containing tyrosine phosphatase 2 to phosphotyrosine. Proc Natl Acad Sci U S A. 2001 Nov 20;98(24):13866-71. doi: 10.1073/pnas.231486598. Epub 2001 Nov 6. PubMed 11698646
  • Parry RV, Chemnitz JM, Frauwirth KA, Lanfranco AR, Braunstein I, Kobayashi SV, Linsley PS, Thompson CB, Riley JL. CTLA-4 and PD-1 receptors inhibit T-cell activation by distinct mechanisms. Mol Cell Biol. 2005 Nov;25(21):9543-53. doi: 10.1128/MCB.25.21.9543-9553.2005. PubMed 16227604
  • Takai Y, Ikeda W, Ogita H, Rikitake Y. The immunoglobulin-like cell adhesion molecule nectin and its associated protein afadin. Annu Rev Cell Dev Biol. 2008;24:309-42. doi: 10.1146/annurev.cellbio.24.110707.175339. PubMed 18593353
  • Rikitake Y, Takai Y. Interactions of the cell adhesion molecule nectin with transmembrane and peripheral membrane proteins for pleiotropic functions. Cell Mol Life Sci. 2008 Jan;65(2):253-63. doi: 10.1007/s00018-007-7290-9. PubMed 17928952
  • Wahler D, Reymond JL. Novel methods for biocatalyst screening. Curr Opin Chem Biol. 2001 Apr;5(2):152-8. doi: 10.1016/s1367-5931(00)00184-8. PubMed 11282341
  • Takai Y, Miyoshi J, Ikeda W, Ogita H. Nectins and nectin-like molecules: roles in contact inhibition of cell movement and proliferation. Nat Rev Mol Cell Biol. 2008 Aug;9(8):603-15. doi: 10.1038/nrm2457. PubMed 18648374
  • Fabre-Lafay S, Monville F, Garrido-Urbani S, Berruyer-Pouyet C, Ginestier C, Reymond N, Finetti P, Sauvan R, Adelaide J, Geneix J, Lecocq E, Popovici C, Dubreuil P, Viens P, Goncalves A, Charafe-Jauffret E, Jacquemier J, Birnbaum D, Lopez M. Nectin-4 is a new histological and serological tumor associated marker for breast cancer. BMC Cancer. 2007 May 2;7:73. doi: 10.1186/1471-2407-7-73. PubMed 17474988
  • Rosenberg J, Sridhar SS, Zhang J, Smith D, Ruether D, Flaig TW, Baranda J, Lang J, Plimack ER, Sangha R, Heath EI, Merchan J, Quinn DI, Srinivas S, Milowsky M, Wu C, Gartner EM, Zuo P, Melhem-Bertrandt A, Petrylak DP. EV-101: A Phase I Study of Single-Agent Enfortumab Vedotin in Patients With Nectin-4-Positive Solid Tumors, Including Metastatic Urothelial Carcinoma. J Clin Oncol. 2020 Apr 1;38(10):1041-1049. doi: 10.1200/JCO.19.02044. Epub 2020 Feb 7. PubMed 32031899
  • Gargiuli C, Sepe P, Tessari A, Sheetz T, Colecchia M, de Braud FGM, Procopio G, Sensi M, Verzoni E, Dugo M. Integrative Transcriptomic Analysis Reveals Distinctive Molecular Traits and Novel Subtypes of Collecting Duct Carcinoma. Cancers (Basel). 2021 Jun 10;13(12):2903. doi: 10.3390/cancers13122903. PubMed 34200770
  • Buti S, Trentini F, Sepe P, Claps M, Isella L, Verzoni E, Procopio G. BONSAI-2 study: Nivolumab as therapeutic option after cabozantinib failure in metastatic collecting duct carcinoma patients. Tumori. 2023 Aug;109(4):418-423. doi: 10.1177/03008916221141483. Epub 2022 Dec 6. PubMed 36474412
  • Procopio G, Verzoni E, Iacovelli R, Colecchia M, Torelli T, Mariani L. Is there a role for targeted therapies in the collecting ducts of Bellini carcinoma? Efficacy data from a retrospective analysis of 7 cases. Clin Exp Nephrol. 2012 Jun;16(3):464-7. doi: 10.1007/s10157-012-0589-3. Epub 2012 Jan 26. PubMed 22278601
  • Mennitto A, Verzoni E, Peverelli G, Alessi A, Procopio G. Management of Metastatic Collecting Duct Carcinoma: An Encouraging Result in a Patient Treated With Cabozantinib. Clin Genitourin Cancer. 2018 Jun;16(3):e521-e523. doi: 10.1016/j.clgc.2018.03.010. Epub 2018 Mar 27. No abstract available. PubMed 29656939