Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus sunitinib | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
nivolumab plus cabozantinib vs. sunitinib | 1 | none | inconclusive results for: DOR; DOR (extension); TRAE (any grade); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade) | statistically conclusive 40 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 30 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable suggested 44 % decrease in PFS (extension) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus everolimus | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
nivolumab alone vs. everolimus | 1 | none | inconclusive results for: deaths (OS) (extension); progression or deaths (PFS); DOR; DOR (extension); objective responses (ORR) (extension); TRAE leading to death (grade 5); Cough TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Epistaxis TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Nausea TRAE (grade 3-4); Peripheral oedema TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4) | statistically conclusive 27 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 50 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 60 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 79 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 97 % decrease in Stomatitis TRAE (grade 3-4) but the degree if certainty is unassessable | - |