Clear cell renal cell carcinoma

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Teja Ganta, MD
Icahn School of Medicine at Mount Sinai
New York, NY

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Ali Raza Khaki, MD
Stanford University
Palo Alto, CA

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Are you looking for a regimen but can't find it here? It is possible that we've moved it to the historical regimens page. For placebo or observational studies in this condition, please visit this page. If you still can't find it, please let us know so we can add it!
There are several related dedicated pages:

3 regimens on this page
3 variants on this page


Guidelines

ASCO

EAU

ESMO

Metastatic disease, first-line

Pembrolizumab monotherapy

Regimen

Study Years of enrollment Evidence Efficacy
McDermott et al. 2021 (KEYNOTE-427) 2016-NR Phase 2 ORR: 36%

Note: this reference describes the clear cell cohort of KEYNOTE-427.

Immunotherapy

21-day cycle for up to 36 cycles (2 years)

References

  1. KEYNOTE-427: McDermott DF, Lee JL, Bjarnason GA, Larkin JMG, Gafanov RA, Kochenderfer MD, Jensen NV, Donskov F, Malik J, Poprach A, Tykodi SS, Alonso-Gordoa T, Cho DC, Geertsen PF, Climent Duran MA, DiSimone C, Silverman RK, Perini RF, Schloss C, Atkins MB. Open-Label, Single-Arm Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Clear Cell Renal Cell Carcinoma. J Clin Oncol. 2021 Mar 20;39(9):1020-1028. Epub 2021 Feb 2. link to original article contains dosing details in abstract PubMed NCT02853344

Metastatic disease, second-line

Nivolumab monotherapy

Regimen

Study Years of enrollment Evidence
McFarlane et al. 2020 (CheckMate 374) 2015-2016 Phase 3b/4

Immunotherapy

14-day cycles

References

  1. CheckMate 374: McFarlane JJ, Kochenderfer MD, Olsen MR, Bauer TM, Molina A, Hauke RJ, Reeves JA, Babu S, Van Veldhuizen P, Somer B, Gunuganti V, Schnadig I, George S, Page RD, Arrowsmith E, Jain RK, Zhang J, McHenry MB, Johansen JL, Vogelzang NJ. Safety and Efficacy of Nivolumab in Patients With Advanced Clear Cell Renal Cell Carcinoma: Results From the Phase IIIb/IV CheckMate 374 Study. Clin Genitourin Cancer. 2020 Dec;18(6):469-476.e4. Epub 2020 Jun 14. link to original article contains dosing details in abstract PubMed NCT02596035

Sorafenib monotherapy

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Escudier et al. 2007 (TARGETRCC) 2003-2005 Phase 3 (E-RT-esc) Placebo Did not meet primary endpoint of OS1

1Reported efficacy for TARGET is based on the 2009 update.
Note that TARGET should not be confused with the study by the same name in breast cancer.

Targeted therapy

  • Sorafenib (Nexavar) 400 mg PO twice per day
    • Can be decreased to 400 mg PO once per day or 400 mg PO every other day if needed due to toxicity

Continued indefinitely

References

  1. TARGET: Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. Erratum in: N Engl J Med. 2007 Jul 12;357(2):203. link to original article contains dosing details in manuscript PubMed NCT00073307
    1. Update: Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Staehler M, Negrier S, Chevreau C, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Anderson S, Hofilena G, Shan M, Pena C, Lathia C, Bukowski RM. Sorafenib for treatment of renal cell carcinoma: final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol. 2009 Jul 10;27(20):3312-8. Epub 2009 May 18. link to original article PubMed
    2. Subgroup analysis: Hutson TE, Bellmunt J, Porta C, Szczylik C, Staehler M, Nadel A, Anderson S, Bukowski R, Eisen T, Escudier B; Sorafenib TARGET Clinical Trial Group. Long-term safety of sorafenib in advanced renal cell carcinoma: follow-up of patients from phase III TARGET. Eur J Cancer. 2010 Sep;46(13):2432-40. Epub 2010 Jul 23. link to original article contains dosing details in manuscript PubMed