summary
GRADE
treatment
patients
risk of bias
overview
DCR deaths (OS) deaths (OS) (extension) DOR MFS MFS (extension) objective responses (ORR) progression or deaths (PFS) RFS (extension) RFS/DFS AE (any grade) AE (grade 3-4) AE leading to death (grade 5) 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) Adrenal insufficiency TRAE (grade 3-4) Colitis TRAE (grade 3-4) Diarrhoea TRAE (grade 3-4) Endocrine disorders TRAE (grade 3-4) Eye disorders TRAE (grade 3-4) Febrile neutropenia TRAE (grade 3-4) Gastrointestinal disorders TRAE (grade 3-4) Guillain-Barré syndrome TRAE (grade 3-4) Hepatitis TRAE (grade 3-4) Hepatobiliary disorders TRAE (grade 3-4) Hypersensitivity 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) Maculopapular rash TRAE (grade 3-4) Nervous system disorders TRAE (grade 3-4) Pancreatitis TRAE (grade 3-4) Pancytopenia TRAE (grade 3-4) Pericarditis TRAE (grade 3-4) Peripheral neuropathy TRAE (grade 3-4) Pneumonitis TRAE (grade 3-4) Polymyalgia Rheumatica TRAE (grade 3-4) Pruritic rash TRAE (grade 3-4) Pruritus TRAE (grade 3-4) Rash 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) Uveitis TRAE (grade 3-4) Vitiligo TRAE (grade 3-4) Abdominal pain AE (grade 3-4) Anaemia AE (grade 3-4) Colitis AE (grade 3-4) Constipation AE (grade 3-4) Cough AE (grade 3-4) Decreased appetite AE (grade 3-4) Diarrhoea AE (grade 3-4) Dyspnoea AE (grade 3-4) Fatigue AE (grade 3-4) Headache AE (grade 3-4) Hypophysitis AE (grade 3-4) Hypothyroidism AE (grade 3-4) Increase AST AE (grade 3-4) Increased ALT AE (grade 3-4) Nausea AE (grade 3-4) Pruritus AE (grade 3-4) Pyrexia AE (grade 3-4) Rash AE (grade 3-4) Vomiting AE (grade 3-4) Weight decreased AE (grade 3-4)
numeric
bar chart
forest plot
medians
frequency on treatment
benefit risk analysis
Study
study type
Pathology T1 T0 Patients sample sizes ROB
Results
E1609 (ipi10), 2020 NCT01274338 RCT mML - NA - all population ipilimumab 10 mg/kg HDI high dose of interferon alpha melanoma of cutaneous or unknown primary origin (AJCC 7th edition stage IIIB, IIIC, or IV [M1a or M1b]) who were rendered disease free surgically. No priorsystemic adjuvant therapy was permitted. 511 / 636 high inconclusive inconclusive 12 % decrease in deaths (OS) (PE) inconclusive 16 % decrease in RFS/DFS (PE) E1609 (ipi3), 2020 NCT01274338 RCT mML - NA - all population ipilimumab 3 mg/kg HDI high dose of interferon alpha melanoma of cutaneous or unknown primary origin (AJCC 7th edition stage IIIB, IIIC, or IV [M1a or M1b]) who were rendered disease free surgically. No priorsystemic adjuvant therapy was permitted. 523 / 636 high conclusif demonstrated 22 % decrease in deaths (OS) (PE) inconclusive 15 % decrease in RFS/DFS (PE) EORTC 18071, 2015 NCT00636168 RCT mML - NA - all population ipilimumab placebo patients with completely resected high-risk stage III melanoma who had not received previous systemic therapy for melanoma 475 / 476 low conclusif demonstrated 28 % decrease in deaths (OS) (PE) demonstrated 25 % decrease in RFS/DFS (PE) demonstrated 24 % decrease in MFS (PE) suggested 27 % decrease in deaths (OS) (extension) more... MDX010 Ipi vs gp100, 2010 NCT00094653 RCT mML - L2 - all population ipilimumab gp100 patients with previously treated metastatic melanoma and had received a previous therapeutic regimen 137 / 136 low conclusif demonstrated 34 % decrease in deaths (OS) (PE) Ascierto (ipi 10 vs 3 mg/kg), 2017 NCT01515189 RCT mML - L2 - all population ipilimumab 10 mg Ipilimumab 3 mg Patients with untreated or previously treated unresectable stage III or IV melanoma, without previous treatment with BRAF inhibitors or immune checkpoint inhibitors, 365 / 362 low conclusif demonstrated 16 % decrease in deaths (OS) (PE)