Study study type PathologyT1T0Patientssample sizesROB Results

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

versus placebo
pembrolizumab alone
KEYNOTE-564 unpublished
  NCT03142334
RCTmetastatic/advanced RCC (mRCC) - (neo)adjuvant(NA)pembrolizumabplaceboPatients (>=18yr), with histologically confirmed locoregional renal-cell carcinoma with a clear-cell component and with criteria for highr risk of recurrence.496 / 498NA
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
  NCT02853331
RCTmetastatic/advanced RCC (mRCC) - 1st line (L1)pembrolizumab plus axitinibsunitinibpatient newly diagnosed or recurrent stage IV clear-cell renal-cell carcinoma; had received no previous systemic therapy for advanced disease;432 / 429some 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
  NCT02811861
RCTmetastatic/advanced RCC (mRCC) - 1st line (L1)lenvatinib plus pembrolizumabsunitinibfirst-line treatment of patients with previously untreated advanced renal cell carcinoma with a clear-cell component355 / 357some 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)