Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
metastatic/advanced RCC (mRCC) - 1st line (L1) metastatic/advanced RCC (mRCC) - 1st line (L1) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus sunitinib | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
nivolumab plus ipilimumab vs. sunitinib | 3 | none | inconclusive results for: progression or deaths (PFS); DOR; TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Acute kidney injury TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Blister TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Colitis TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Dyspepsia TRAE (grade 3-4); Eczema TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Erythema TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; Hepatobiliary disorders TRAE (grade 3-4) ; Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increase AST TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Increased lipase level TRAE (grade 3-4); Maculopapular rash TRAE (grade 3-4); Nausea TRAE (grade 3-4); Pruritic rash TRAE (grade 3-4); Pruritus generalised TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Renal and urinary disorders TRAE (grade 3-4) ; Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) ; Skin exfoliation TRAE (grade 3-4); Skin hypopigmentation TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Urticaria TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | suggested 32 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 29 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable suggested 15 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 35 % increase in objective responses (ORR) but the degree if certainty is unassessable suggested 59 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 51 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 92 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 56 % decrease in Fatigue TRAE (grade 3-4) but the degree if certainty is unassessable suggested 96 % decrease in Hypertension 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 | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 |