Non-clear cell renal cell carcinoma

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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:
*General RCC page: Renal cell carcinoma
*Histology-specific:
**Clear cell renal cell carcinoma 
**Non-clear cell renal cell carcinoma (this page)
***Papillary renal cell carcinoma
***Sarcomatoid renal cell carcinoma
*Biomarker-specific:
**RCC, VHL-associated
Last updated on 2024-07-23:3 regimens on this page
3 variants on this page
=Guidelines=
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
==NCCN==
*NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Kidney Cancer.
=Metastatic disease, first-line=
==Everolimus monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Tannir et al. 2015 (ESPN) 	2010-2013 	Randomized Phase 2 (E-switch-ic)	Sunitinib 	Did not meet primary endpoint of PFS
Armstrong et al. 2016 (ASPENRCC)	2010-2013 	Randomized Phase 2 (E-switch-ic)	Sunitinib 	Might have shorter PFS (primary endpoint)
Note: ASPEN should not be confused with the trial by the same name in Waldenström macroglobulinemia.
====Targeted therapy====
*Everolimus (Afinitor) 10 mg PO once per day
Continued indefinitely
====Dose and schedule modifications====
*ESPN: Dose can be reduced to 5 mg PO once per day or every other day if needed based on tolerability
===References===
#ESPN: Tannir NM, Jonasch E, Albiges L, Altinmakas E, Ng CS, Matin SF, Wang X, Qiao W, Dubauskas Lim Z, Tamboli P, Rao P, Sircar K, Karam JA, McDermott DF, Wood CG, Choueiri TK. Everolimus versus sunitinib prospective evaluation in metastatic non-clear cell renal cell carcinoma (ESPN): a randomized multicenter phase 2 trial. Eur Urol. 2016 May;69(5):866-74. Epub 2015 Nov 26. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT01185366
#ASPEN: Armstrong AJ, Halabi S, Eisen T, Broderick S, Stadler WM, Jones RJ, Garcia JA, Vaishampayan UN, Picus J, Hawkins RE, Hainsworth JD, Kollmannsberger CK, Logan TF, Puzanov I, Pickering LM, Ryan CW, Protheroe A, Lusk CM, Oberg S, George DJ. Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial. Lancet Oncol. 2016 Mar;17(3):378-88. Epub 2016 Jan 13. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT01108445
==Pembrolizumab monotherapy==
===Regimen===
Study 	Dates of enrollment 	Evidence	Efficacy
McDermott et al. 2021 (KEYNOTE-427nccRCC)	2016 to not reported	Phase 2 	ORR: 27%
Note: this reference described the non-clear cell cohort of KEYNOTE-427.
====Immunotherapy====
*Pembrolizumab (Keytruda) 200 mg IV once on day 1
21-day cycle for up to 36 cycles (2 years)
===References===
#KEYNOTE-427nccRCC: McDermott DF, Lee JL, Ziobro M, Suarez C, Langiewicz P, Matveev VB, Wiechno P, Gafanov RA, Tomczak P, Pouliot F, Donskov F, Alekseev BY, Shin SJ, Bjarnason GA, Castellano D, 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 Non-Clear Cell Renal Cell Carcinoma. J Clin Oncol. 2021 Mar 20;39(9):1029-1039. Epub 2021 Feb 2. link to original article dosing details in abstract have been reviewed by our editors link to PMC article EuroPMC NCT02853344
==Sunitinib monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Tannir et al. 2015 (ESPN) 	2010-2013 	Randomized Phase 2 (E-switch-ic)	Everolimus	Did not meet primary endpoint of PFS
Armstrong et al. 2016 (ASPENRCC)	2010-2013 	Randomized Phase 2 (E-switch-ic)	Everolimus	Might have longer PFS (primary endpoint)Median PFS: 8.3 vs 5.6 mo(HR 0.71, 80% CI 0.52-0.97)
Note: ASPEN should not be confused with the trial by the same name in Waldenström macroglobulinemia.
====Targeted therapy====
*Sunitinib (Sutent) 50 mg PO once per day on days 1 to 28
42-day cycles
====Dose and schedule modifications====
*Per some references, dose may be decreased to 37.5 mg or 25 mg PO once per day depending on tolerability
===References===
#ESPN: Tannir NM, Jonasch E, Albiges L, Altinmakas E, Ng CS, Matin SF, Wang X, Qiao W, Dubauskas Lim Z, Tamboli P, Rao P, Sircar K, Karam JA, McDermott DF, Wood CG, Choueiri TK. Everolimus versus sunitinib prospective evaluation in metastatic non-clear cell renal cell carcinoma (ESPN): a randomized multicenter phase 2 trial. Eur Urol. 2016 May;69(5):866-74. Epub 2015 Nov 26. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT01185366
#ASPEN: Armstrong AJ, Halabi S, Eisen T, Broderick S, Stadler WM, Jones RJ, Garcia JA, Vaishampayan UN, Picus J, Hawkins RE, Hainsworth JD, Kollmannsberger CK, Logan TF, Puzanov I, Pickering LM, Ryan CW, Protheroe A, Lusk CM, Oberg S, George DJ. Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial. Lancet Oncol. 2016 Mar;17(3):378-88. Epub 2016 Jan 13. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT01108445
Category:Non-clear cell renal cell carcinoma regimens
Category:Histology-specific pages
Category:Renal cell carcinomas