Study Summary
This trial will study the safety of combining nivolumab+ipilimumab with embolization in patients with metastatic renal cell carcinoma.
- Kidney Cancer Stage IV
- Kidney Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Measured from baseline to 6 months post initiation
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Ipilimumab +Nivolumab with Embolization
1 of 1
Experimental Treatment
22 Total Participants · 1 Treatment Group
Primary Treatment: bland embolization · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 15 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Motzer, Robert J., Nizar M. Tannir, David F. McDermott, Osvaldo Arén Frontera, Bohuslav Melichar, Toni K. Choueiri, Elizabeth R. Plimack, et al.. 2018. “Nivolumab Plus Ipilimumab Versus Sunitinib in Advanced Renal-cell Carcinoma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1712126.
- den Brok, M H M G M, R P M Sutmuller, S Nierkens, E J Bennink, C Frielink, L W J Toonen, O C Boerman, C G Figdor, T J M Ruers, and G J Adema. 2006. “Efficient Loading of Dendritic Cells Following Cryo and Radiofrequency Ablation in Combination with Immune Modulation Induces Anti-tumour Immunity”. British Journal of Cancer. Springer Science and Business Media LLC. doi:10.1038/sj.bjc.6603341.
- Demirci, Deniz, Atila Tatlışen, Oğuz Ekmekçioğlu, Nevzat Özcan, and Reşat Kaya. 2004. “Does Radical Nephrectomy with Immunochemotherapy Have Any Superiority over Embolization Alone in Metastatic Renal Cell Carcinoma?”. Urologia Internationalis. S. Karger AG. doi:10.1159/000078805.
- Kato, Taigo, Tomoyuki Iwasaki, Motohide Uemura, Akira Nagahara, Hiroki Higashihara, Keigo Osuga, Yuji Ikeda, et al.. 2017. “Characterization of the Cryoablation-induced Immune Response in Kidney Cancer Patients”. Oncoimmunology. Informa UK Limited. doi:10.1080/2162402x.2017.1326441.
- Sabel, Michael S.. 2009. “Cryo-immunology: A Review of the Literature and Proposed Mechanisms for Stimulatory Versus Suppressive Immune Responses”. Cryobiology. Elsevier BV. doi:10.1016/j.cryobiol.2008.10.126.
- Zielinski, Henryk, Stanislaw Szmigielski, and Zbigniew Petrovich. 2000. “Comparison of Preoperative Embolization Followed by Radical Nephrectomy with Radical Nephrectomy Alone for Renal Cell Carcinoma”. American Journal of Clinical Oncology: Cancer Clinical Trials. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00000421-200002000-00002.
- Mehta, Amol, Rahmi Oklu, and Rahul A. Sheth. 2016. “Thermal Ablative Therapies and Immune Checkpoint Modulation: Can Locoregional Approaches Effect a Systemic Response?”. Gastroenterology Research and Practice. Hindawi Limited. doi:10.1155/2016/9251375.
- Motzer, Robert J., Nizar M. Tannir, David F. McDermott, Osvaldo Arén Frontera, Bohuslav Melichar, Toni K. Choueiri, Elizabeth R. Plimack, et al.. 2018. “Nivolumab Plus Ipilimumab Versus Sunitinib in Advanced Renal-cell Carcinoma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1712126.
- Sabel MS. Cryo-immunology: a review of the literature and proposed mechanisms for stimulatory versus suppressive immune responses. Cryobiology. 2009 Feb;58(1):1-11. doi: 10.1016/j.cryobiol.2008.10.126. Epub 2008 Oct 17.
- Motzer RJ, Tannir NM, McDermott DF, Aren Frontera O, Melichar B, Choueiri TK, Plimack ER, Barthelemy P, Porta C, George S, Powles T, Donskov F, Neiman V, Kollmannsberger CK, Salman P, Gurney H, Hawkins R, Ravaud A, Grimm MO, Bracarda S, Barrios CH, Tomita Y, Castellano D, Rini BI, Chen AC, Mekan S, McHenry MB, Wind-Rotolo M, Doan J, Sharma P, Hammers HJ, Escudier B; CheckMate 214 Investigators. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018 Apr 5;378(14):1277-1290. doi: 10.1056/NEJMoa1712126. Epub 2018 Mar 21.
- den Brok MH, Sutmuller RP, Nierkens S, Bennink EJ, Frielink C, Toonen LW, Boerman OC, Figdor CG, Ruers TJ, Adema GJ. Efficient loading of dendritic cells following cryo and radiofrequency ablation in combination with immune modulation induces anti-tumour immunity. Br J Cancer. 2006 Oct 9;95(7):896-905. doi: 10.1038/sj.bjc.6603341. Epub 2006 Sep 5.
- Zielinski H, Szmigielski S, Petrovich Z. Comparison of preoperative embolization followed by radical nephrectomy with radical nephrectomy alone for renal cell carcinoma. Am J Clin Oncol. 2000 Feb;23(1):6-12. doi: 10.1097/00000421-200002000-00002.
- Swanson DA, Wallace S. Surgery of metastatic renal cell carcinoma and use of renal infarction. Semin Surg Oncol. 1988;4(2):124-8.
- Mehta A, Oklu R, Sheth RA. Thermal Ablative Therapies and Immune Checkpoint Modulation: Can Locoregional Approaches Effect a Systemic Response? Gastroenterol Res Pract. 2016;2016:9251375. doi: 10.1155/2016/9251375. Epub 2016 Mar 8.
- 2020. "Nivolumab + Ipilimumab With Immunostimulatory Embolization for Stage 4 Renal Cell Carcinoma With Unresected Primary". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04429321.
Frequently Asked Questions
Is admission to this trial available at the moment?
"The current status of the clinical trial is recruiting, according to information provided on clinicaltrials.gov. It was initially announced on August 26th 2020 and subsequently updated most recently in March 14th 2022." - Anonymous Online Contributor
To what degree could bland embolization pose a hazard to patients?
"Due to the limited data collected in Phase 1 trials, our team at Power rated bland embolization safety a score of 1." - Anonymous Online Contributor
What is the aggregate participant count of this healthcare experiment?
"Affirmative. According to clinicaltrials.gov, this trial is in the process of recruiting participants with an initial posting on August 26th 2020 and a recently updated version posted on March 14th 2022. 22 individuals are sought from 1 particular facility." - Anonymous Online Contributor
What health conditions does bland embolization typically address?
"Bland embolization is frequently deployed to address the effects of anti-angiogenic therapy. In addition, it can be used to treat certain malignant neoplasms, melanomas that are inoperable and squamous cell carcinoma." - Anonymous Online Contributor
What other research endeavors have focused on bland embolization?
"Presently, 86 Phase 3 trials for bland embolization are ongoing and 764 of these clinical studies remain active. Although the majority of them originate from Pittsburgh, Pennsylvania, a total of 42760 sites offer this type of medical research." - Anonymous Online Contributor