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	KEYNOTE-564 unpublished Aktuelle Urol 2019; 50:578-580 New England Journal of Medicine Journal of Clinical Oncology NCT03142334	RCT	metastatic/advanced RCC (mRCC) - (neo)adjuvant(NA)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
	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)