metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
metastatic/advanced RCC (mRCC) - (neo)adjuvant(NA) metastatic/advanced RCC (mRCC) - (neo)adjuvant(NA)
versus placebo
	pembrolizumab alone
	KEYNOTE-564 unpublished Aktuelle Urol 2019; 50:578-580 New England Journal of Medicine Journal of Clinical Oncology NCT03142334	RCT	metastatic/advanced RCC (mRCC) - (neo)adjuvant(NA)	pembrolizumab	placebo	Patients (>=18yr), with histologically confirmed locoregional renal-cell carcinoma with a clear-cell component and with criteria for highr risk of recurrence.	496 / 498	NA	conclusif	suggested 46 % decrease in deaths (OS) (PE) demonstrated 32 % decrease in RFS/DFS (PE)
metastatic/advanced RCC (mRCC) - 1st line (L1) metastatic/advanced RCC (mRCC) - 1st line (L1)
versus sunitinib
	atezolizumab alone
	IMmotion-150 (At - all population), 2018 Nat. Med. 2018; 24:749-757 BJU Int 2020 Jul;126(1):73-82. NCT01984242	RCT	metastatic/advanced RCC (mRCC) - 1st line (L1)	atezolizumab	sunitinib	unresectable advanced or mRCC with a component of clear cell histology and/or sarcomatoid histology not previously treated with any systemic agents for RCC	103 / 101	some concern	inconclusive	inconclusive 19 % increase in progression or deaths (PFS) (PE)
	atezolizumab plus bevacizumab
	IMmotion-151 (all population), 2019 Lancet 2019; 393:2404-2415 Clin Cancer Res 2020; 26:2506-2514 NCT02420821	RCT	metastatic/advanced RCC (mRCC) - 1st line (L1)	atezolizumab plus bevacizumab	Sunitinib	patients with unresectable locally advanced or metastatic renal cell carcinoma with any component of clear cell or sarcomatoid histology, with Karnofsky performance status 70% or higher.	454 / 461	high	inconclusive	inconclusive 7 % decrease in deaths (OS) (PE)
	IMmotion-150 (AtB - all population), 2018 Nat. Med. 2018; 24:749-757 BJU Int 2020 Jul;126(1):73-82. NCT01984242	RCT	metastatic/advanced RCC (mRCC) - 1st line (L1)	atezolizumab with bevacizumab	sunitinib	unresectable advanced or mRCC with a component of clear cell histology and/or sarcomatoid histology not previously treated with any systemic agents for RCC	101 / 101	some concern	inconclusive	inconclusive 0 % increase in progression or deaths (PFS) (PE)
	avelumab plus axitinib
	JAVELIN Renal 101 (all population), 2019 N. Engl. J. Med. 2019; 380:1103-1115 Cancer Sci. 2020; 111:907-923 Nat Med 2020 Sep 7. Ann Oncol 2020 Aug;31(8):1030-1039. ESMO Open 2021 Apr 23;6(3):100101. NCT02684006	RCT	metastatic/advanced RCC (mRCC) - 1st line (L1)	Avelumab plus Axitinib	Sunitinib	patients with previously untreated advanced renal cell carcinoma	442 / 444	some concern	conclusif	demonstrated 31 % decrease in progression or deaths (PFS) (PE) suggested 31 % decrease in PFS (extension)
	lenvatinib plus everolimus
	KEYNOTE-581/CLEAR (mtor), 2021 N Engl J Med 2021 Apr 8;384(14):1289-1300. NCT02811861	RCT	metastatic/advanced RCC (mRCC) - 1st line (L1)	lenvatinib plus everolimus	sunitinib	first-line treatment of patients with previously untreated advanced renal cell carcinoma with a clear-cell component	357 / 357	some concern	conclusif	demonstrated 35 % decrease in progression or deaths (PFS) (PE)
	nivolumab plus cabozantinib
	CheckMate 9ER, 2021 Ann Oncol. 2020;31(4). Abstract 696O N Engl J Med 2021 Mar 4;384(9):829-841. 2022 ASCO Genitourinary Cancers Symposium Lancet Oncol 2022; 23:292-303-. NCT03141177	RCT	metastatic/advanced RCC (mRCC) - 1st line (L1)	Nivolumab and Cabozantinib	Sunitinib	patients with previously untreated advanced or metastatic RCC that had a clear cell component	323 / 328	some concern	conclusif	demonstrated 40 % decrease in deaths (OS) (PE) demonstrated 49 % decrease in progression or deaths (PFS) (PE) suggested 30 % decrease in deaths (OS) (extension) suggested 44 % decrease in PFS (extension) more... nivolumab (Opdivo) and cabozantinib (Cabometyx) demonstrated superior PFS, OS, and ORR compared with first-line sunitinib (Sutent) in patient with advanced clear cell renal cell carcinoma
	nivolumab plus ipilimumab
	CheckMate 214 (favorable risk) EXPLORATORY, 2017 Lancet Oncol. 2019; 20:1370-1385 N. Engl. J. Med. 2018; 378:1277-1290 J Immunother Cancer 2020 Jul;8(2):e000891. Jpn J Clin Oncol 2020 Jan 24;50(1):12-19. Immunotherapy 2020 Jan;12(1):37-51. Lancet Oncol 2019 Feb;20(2):297-310. NCT02231749	RCT	metastatic/advanced RCC (mRCC) - 1st line (L1)	nivolumab plus ipilimumab	sunitinib	patients previously untreated advanced or metastatic renal cell carcinoma with a clear-cell component, with favorable risk (IMDCC)	125 / 124	some concern	inconclusive	statistically significant 1.2-fold increase in progression or deaths (PFS)
	CheckMate 214 (all population), 2017 Lancet Oncol. 2019; 20:1370-1385 N. Engl. J. Med. 2018; 378:1277-1290 Urologe A 2015; 54:1443-5 J Immunother Cancer 2020 Jul;8(2):e000891. Jpn J Clin Oncol 2020 Jan 24;50(1):12-19. Clin Cancer Res 2020 Sep 1. NCT02231749	RCT	metastatic/advanced RCC (mRCC) - 1st line (L1)	nivolumab plus ipilimumab	sunitinib	patients previously untreated advanced or metastatic renal cell carcinoma with a clear-cell component	550 / 546	some concern	inconclusive	suggested 32 % decrease in deaths (OS) suggested 29 % decrease in deaths (OS) (extension) suggested 15 % decrease in PFS (extension)
	CheckMate 214 (intermediate and poor risk), 2017 Lancet Oncol. 2019; 20:1370-1385 N. Engl. J. Med. 2018; 378:1277-1290 J Immunother Cancer 2020 Jul;8(2):e000891. Jpn J Clin Oncol 2020 Jan 24;50(1):12-19. Immunotherapy 2020 Jan;12(1):37-51. Lancet Oncol 2019 Feb;20(2):297-310. Eur Urol 2022; 81:266-271-. Cancer 2022; 128:2085-2097-. NCT02231749	RCT	metastatic/advanced RCC (mRCC) - 1st line (L1)	nivolumab plus ipilimumab	sunitinib	patients previously untreated advanced or metastatic renal cell carcinoma with a clear-cell component	425 / 422	some concern	conclusif	demonstrated 37 % decrease in deaths (OS) (PE) inconclusive 18 % decrease in progression or deaths (PFS) (PE) suggested 34 % decrease in deaths (OS) (extension) suggested 23 % decrease in PFS (extension) more...
	pembrolizumab plus axitinib
	KEYNOTE-426, 2019 N Engl J Med 2019;380:1116-1127 Urologe A 2017; 56:385-386 Lancet Oncol 2020 NCT02853331	RCT	metastatic/advanced RCC (mRCC) - 1st line (L1)	pembrolizumab plus axitinib	sunitinib	patient newly diagnosed or recurrent stage IV clear-cell renal-cell carcinoma; had received no previous systemic therapy for advanced disease;	432 / 429	some concern	conclusif	demonstrated 47 % decrease in deaths (OS) (PE) demonstrated 31 % decrease in progression or deaths (PFS) (PE) suggested 32 % decrease in deaths (OS) (extension) suggested 29 % decrease in PFS (extension) more...
	pembrolizumab plus lenvatinib
	KEYNOTE-581/CLEAR (PDL1), 2021 N Engl J Med 2021 Apr 8;384(14):1289-1300. NCT02811861	RCT	metastatic/advanced RCC (mRCC) - 1st line (L1)	lenvatinib plus pembrolizumab	sunitinib	first-line treatment of patients with previously untreated advanced renal cell carcinoma with a clear-cell component	355 / 357	some concern	conclusif	demonstrated 34 % decrease in deaths (OS) (PE) demonstrated 61 % decrease in progression or deaths (PFS) (PE) demonstrated 97 % increase in objective responses (ORR) (PE) The combination of pembrolizumab (Keytruda) plus lenvatinib (Lenvima) significantly improved progression-free survival (PFS), overall survival (OS), and the objective response rate (ORR) compared with sunitinib (Sutent)
mRCC - L1 - PDL1 negative metastatic/advanced RCC (mRCC) - 1st line (L1) mRCC - L1 - PDL1 negative
versus sunitinib
	atezolizumab plus bevacizumab
	IMmotion-151 (PDL1 <1%) EXPLORATORY, 2019 Lancet 2019; 393:2404-2415 Clin Cancer Res 2020; 26:2506-2514 NCT02420821	RCT	mRCC - L1 - PDL1 negative	atezolizumab plus bevacizumab	Sunitinib	Patients with unresectable locally advanced or metastatic renal cell carcinoma with any component of clear cell or sarcomatoid histology (PDL1 negative patients)	276 / 277	high	inconclusive	no statistically significant result
mRCC - L1 - PDL1 positive metastatic/advanced RCC (mRCC) - 1st line (L1) mRCC - L1 - PDL1 positive
versus sunitinib
	atezolizumab alone
	IMmotion-150 (At - PDL1>1%), 2018 Nat. Med. 2018; 24:749-757 BJU Int 2020 Jul;126(1):73-82. NCT01984242	RCT	mRCC - L1 - PDL1 positive	atezolizumab	sunitinib	unresectable advanced or mRCC with a component of clear cell histology and/or sarcomatoid histology not previously treated with any systemic agents for RCC. Patients had PDL1 >1%	54 / 60	some concern	inconclusive	inconclusive 3 % increase in progression or deaths (PFS) (PE)
	atezolizumab plus bevacizumab
	IMmotion-151 (PDL1 >1%), 2019 Lancet 2019; 393:2404-2415 Clin Cancer Res 2020; 26:2506-2514 NCT02420821	RCT	mRCC - L1 - PDL1 positive	atezolizumab plus bevacizumab	Sunitinib	patients with unresectable locally advanced or metastatic renal cell carcinoma with any component of clear cell or sarcomatoid histology	178 / 184	high	inconclusive	no statistically significant result
	IMmotion-150 (AtB - PDL1>1%), 2018 Nat. Med. 2018; 24:749-757 BJU Int 2020 Jul;126(1):73-82. NCT01984242	RCT	mRCC - L1 - PDL1 positive	atezolizumab with bevacizumab	sunitinib	unresectable advanced or mRCC with a component of clear cell histology and/or sarcomatoid histology not previously treated with any systemic agents for RCC. patients with PDL1 >1% positive only	50 / 60	some concern	suggested	inconclusive 36 % decrease in progression or deaths (PFS) (PE)
	avelumab plus axitinib
	JAVELIN Renal 101( PDL1>1%), 2019 N. Engl. J. Med. 2019; 380:1103-1115 Cancer Sci. 2020; 111:907-923 Nat Med 2020 Sep 7. Ann Oncol 2020 Aug;31(8):1030-1039. ESMO Open 2021 Apr 23;6(3):100101. NCT02684006	RCT	mRCC - L1 - PDL1 positive	Avelumab plus Axitinib	Sunitinib	patients with previously untreated advanced renal cell carcinoma (PDL1>1% population)	270 / 290	some concern	conclusif	suggested 31 % decrease in deaths (OS) (PE) demonstrated 39 % decrease in progression or deaths (PFS) (PE) suggested 38 % decrease in PFS (extension)
metastatic/advanced RCC (mRCC) - 2nd line (L2) metastatic/advanced RCC (mRCC) - 2nd line (L2)
versus everolimus
	nivolumab alone
	CheckMate 025, 2015 N Engl J Med 2015;373:1803-13 Jpn. J. Clin. Oncol. 2019; 49:506-514 Jpn. J. Clin. Oncol. 2017; 47:639-646 Eur. Urol. 2017; 72:368-376 Eur. Urol. 2017; 72:962-971 Lancet Oncol. 2016; 17:994-1003 NCT01668784	RCT	metastatic/advanced RCC (mRCC) - 2nd line (L2)	nivolumab	everolimus	patients with advanced clear-cell renal-cell carcinoma for which they had received previous treatment with one or two regimens of antiangiogenic therapy	410 / 411	some concern	conclusif	demonstrated 27 % decrease in deaths (OS) (PE) demonstrated 5.0-fold increase in objective responses (ORR) (PE)

metastatic/advanced RCC (mRCC) - (neo)adjuvant(NA) metastatic/advanced RCC (mRCC) - (neo)adjuvant(NA)

metastatic/advanced RCC (mRCC) - 1st line (L1) metastatic/advanced RCC (mRCC) - 1st line (L1)

mRCC - L1 - PDL1 negative metastatic/advanced RCC (mRCC) - 1st line (L1) mRCC - L1 - PDL1 negative

mRCC - L1 - PDL1 positive metastatic/advanced RCC (mRCC) - 1st line (L1) mRCC - L1 - PDL1 positive

metastatic/advanced RCC (mRCC) - 2nd line (L2) metastatic/advanced RCC (mRCC) - 2nd line (L2)