| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
mML - NA - all population metastatic/adv melanoma (mML) mML - (neo)adjuvant (NA) mML - NA - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus nivolumab alone | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab plus ipilimumab vs. nivolumab alone | 1 | none | inconclusive results for: AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); AE leading to treatment discontinuation (grade 3-4); SAE (any grade); SAE (grade 3-4); STRAE (any grade); STRAE (grade 3-4); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Abdominal pain TRAE (grade 3-4); Acute kidney injury TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Blood and lymphatic system disorders TRAE (grade 3-4); Chills TRAE (grade 3-4); Colitis TRAE (grade 3-4); Cough TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dizziness TRAE (grade 3-4); Dry skin TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Dyspepsia TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Ear and labyrinth disorders TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Eye disorders TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Gastritis TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; General disorders and administration site conditions TRAE (grade 3-4); Headache TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hepatobiliary disorders TRAE (grade 3-4) ; Hypertension 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); Infusion-related reactions TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Maculopapular rash TRAE (grade 3-4); Metabolism and nutrition disorders TRAE (grade 3-4); Musculoskeletal and connective tissue disorders TRAE (grade 3-4); Myalgia TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nervous system disorders TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Paraesthesia TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) ; Sarcoidosis TRAE (grade 3-4); Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Stomatitis TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Uveitis TRAE (grade 3-4); Vitiligo TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Weight decreased TRAE (grade 3-4) | suggested 60 % decrease in RFS/DFS but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab plus ipilimumab vs. placebo | 1 | none | inconclusive results for: AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); AE leading to treatment discontinuation (grade 3-4); SAE (any grade); SAE (grade 3-4); STRAE (any grade); STRAE (grade 3-4); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Abdominal pain TRAE (grade 3-4); Acute kidney injury TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Blood and lymphatic system disorders TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Chills TRAE (grade 3-4); Colitis TRAE (grade 3-4); Cough TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dizziness TRAE (grade 3-4); Dry skin TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Dyspepsia TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Ear and labyrinth disorders TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Eye disorders TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Gastritis TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; General disorders and administration site conditions TRAE (grade 3-4); Headache TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hepatobiliary disorders TRAE (grade 3-4) ; Hypertension 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); Infusion-related reactions TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Maculopapular rash TRAE (grade 3-4); Metabolism and nutrition disorders TRAE (grade 3-4); Musculoskeletal and connective tissue disorders TRAE (grade 3-4); Myalgia TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nervous system disorders TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Paraesthesia TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) ; Sarcoidosis TRAE (grade 3-4); Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Stomatitis TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Uveitis TRAE (grade 3-4); Vitiligo TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Weight decreased TRAE (grade 3-4) | statistically conclusive 77 % decrease in RFS/DFS but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mML - NA - PDL1 positive metastatic/adv melanoma (mML) mML - (neo)adjuvant (NA) mML - NA - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mML - L1 - all population metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus ipilimumab alone | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab plus ipilimumab vs. ipilimumab alone | 2 | statistically conclusive 42 % decrease in deaths (OS) suggested 59 % decrease in PFS (extension) statistically conclusive 59 % decrease in progression or deaths (PFS) statistically conclusive 9.4-fold increase in objective responses (ORR) suggested 7.4-fold increase in objective responses (ORR) (extension) | inconclusive results for: DOR; TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Abdominal pain TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Chills TRAE (grade 3-4); Colitis TRAE (grade 3-4); Constipation TRAE (grade 3-4); Cough TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dry skin TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Fatigue TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; Headache TRAE (grade 3-4); Hepatitis 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); Myalgia TRAE (grade 3-4); Nausea TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritic rash TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia 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 and subcutaneous tissue disorders TRAE (grade 3-4) ; Thyroiditis TRAE (grade 3-4); Vitiligo TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Weight decreased TRAE (grade 3-4) | suggested 48 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus nivolumab alone | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab plus ipilimumab vs. nivolumab alone | 1 | none | inconclusive results for: deaths (OS) (extension); DOR; TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Abdominal pain TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Cough TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dry skin TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Headache TRAE (grade 3-4); Hepatitis 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); Myalgia TRAE (grade 3-4); Nausea TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritic rash TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Rash TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Vitiligo TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Weight decreased TRAE (grade 3-4) | suggested 35 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 21 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 26 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable suggested 76 % increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| relatlimab plus nivolumab vs. nivolumab alone | 1 | none | - | suggested 25 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mML - L1 - BRAF mutant metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - BRAF mutant | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus ipilimumab alone | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab plus ipilimumab vs. ipilimumab alone | 1 | none | inconclusive results for: deaths (OS); PFS (extension); objective responses (ORR); objective responses (ORR) (extension) | suggested 62 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mML - L1 - BRAF wild metastatic/adv melanoma (mML) mML - 1st line (L1) mML - L1 - BRAF wild | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus ipilimumab alone | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab plus ipilimumab vs. ipilimumab alone | 1 | none | inconclusive results for: DOR; TRAE leading to discontinuation (any grade) | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mML - L2 - all population metastatic/adv melanoma (mML) mML - 2nd line (L2) mML - L2 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mML - L2 - BRAF mutant metastatic/adv melanoma (mML) mML - 2nd line (L2) mML - L2 - BRAF mutant | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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