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KEYNOTE-581/CLEAR (mtor), 2021 NCT02811861

lenvatinib plus everolimus (n=357) vs. sunitinib (n=357)

randomized controlled trial

Studied treatment

lenvatinib plus everolimus
lenvatinib was administered at a dose of 18 mg and everolimus was administered at a dose of 5 mg orally once daily for each 21-day cycle.

Control treatment

sunitinib
Sunitinib (50 mg orally once daily for four weeks on treatment, followed by two weeks off treatment)

3 arms : lenvatinib plus pembrolizumab, lenvatinib plus everolimus and sunitinib

Patients

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

Karnofsky performance-status scoreof at least 70

Method

open label

200 sites in 20 countries

P3/ two sided and two interim analysis. A sequential approach for multiple comparisons was used to adjust for multiplicity and to control the familywise error rate for progression-free survival and overall survival and the percentage of patients with an objective responseat the alpha of 0.0499 (two-sided) in comparisonsof each combination regimen with sunitinib.

Remark

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) as first line in patient with advancedrenal cell carcinoma