All patients
Age < 65y (younger) Age > 65y BRAF mutant BRAF wild type ECOG 0 ECOG 1 Gender, female Gender, male LDH > ULN LDH ≤ULN previous systemic treatment (%) previous systemic treatment NO (%) stage IIIa stage IIIb stage IIIc stage M0/M1A/M1B stage M1C stage M1C (with brain metastasis)
Top evidence (RCT only, high risk of bias excluded)
Best available evidence (possibly low or very low)
All RCTs
All studies (RCT+OBS)
melanoma (ML), ipilimumab alone vs. ipilimumab based treatment, meta-analysis of study results Outcome TE 95% CI n k I2 ROB Pub. bias deaths (OS)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1.19 [1.00; 1.42]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.96 [0.77; 1.20]
1.08 [0.88 ; 1.33 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2 54% 1,267 low not evaluable progression or deaths (PFS)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1.12 [0.83; 1.52]
1.12 [0.83 ; 1.52 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 727 NA not evaluable DCRdetailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.84 [0.61; 1.16]
0.84 [0.61 ; 1.16 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 727 NA not evaluable objective responses (ORR)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.76 [0.50; 1.17]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2.03 [1.03; 4.02]
1.20 [0.46 ; 3.12 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2 82% 1,267 low not evaluable AE (any grade)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.51 [0.14; 1.83]
0.51 [0.14 ; 1.83 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1 0% 511 NA not evaluable AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.01 [0.68; 1.51]
1.01 [0.68 ; 1.51 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1 0% 511 NA not evaluable TRAE (any grade)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.42 [0.31; 0.57]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.50 [0.29; 0.86]
0.44 [0.33 ; 0.57 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2 0% 1,237 low not evaluable TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.37 [0.25; 0.54]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.86 [0.50; 1.48]
0.55 [0.24 ; 1.25 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2 84% 1,237 low not evaluable TRAE leading to death (grade 5)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.50 [0.09; 2.75]
0.50 [0.09 ; 2.75 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable TRAE leading to discontinuation (any grade)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.51 [0.36; 0.72]
0.51 [0.36 ; 0.72 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable TRAE leading to discontinuation (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.44 [0.30; 0.66]
0.44 [0.30 ; 0.66 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Adrenal insufficiency TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.50 [0.02; 15.01]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.72 [0.03; 16.16]
0.61 [0.06 ; 6.07 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2 0% 1,237 low not evaluable Colitis TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.46 [0.21; 1.04]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.73 [0.67; 4.49]
0.87 [0.24 ; 3.18 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2 77% 1,237 low not evaluable Diarrhoea TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.54 [0.31; 0.95]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.25 [0.47; 3.34]
0.75 [0.34 ; 1.65 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2 53% 1,237 low not evaluable Endocrine disorders TRAE (grade 3-4) detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.43 [0.19; 1.01]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 3.73 [0.99; 14.11]
1.19 [0.15 ; 9.79 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2 86% 1,237 low not evaluable Eye disorders TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 2.01 [0.07; 60.22]
2.01 [0.07 ; 60.22 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Febrile neutropenia TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.25 [0.01; 5.57]
0.25 [0.01 ; 5.57 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Gastrointestinal disorders TRAE (grade 3-4) detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.55 [0.34; 0.88]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.34 [0.62; 2.92]
0.81 [0.34 ; 1.94 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2 73% 1,237 low not evaluable Guillain-Barré syndrome TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.25 [0.01; 5.57]
0.25 [0.01 ; 5.57 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Hepatitis TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.40 [0.08; 2.07]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.45 [0.05; 43.54]
0.51 [0.12 ; 2.24 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2 0% 1,237 low not evaluable Hepatobiliary disorders TRAE (grade 3-4) detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.36 [0.02; 6.86]
0.36 [0.02 ; 6.86 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1 0% 511 NA not evaluable Hypersensitivity TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.17 [0.01; 3.33]
0.17 [0.01 ; 3.33 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Hypophysitis TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.70 [0.26; 1.85]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2.93 [0.41; 21.02]
1.10 [0.30 ; 4.05 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2 39% 1,237 low not evaluable Hypothyroidism TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.50 [0.02; 15.01]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.45 [0.05; 43.54]
0.85 [0.08 ; 9.44 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2 0% 1,237 low not evaluable Increase AST TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.12 [0.02; 0.99]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.45 [0.05; 43.54]
0.29 [0.03 ; 2.88 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2 32% 1,237 low not evaluable Increased ALT TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.16 [0.04; 0.73]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.72 [0.03; 16.16]
0.22 [0.06 ; 0.84 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2 0% 1,237 low not evaluable Increased lipase level TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.50 [0.02; 15.01]
0.50 [0.02 ; 15.01 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Infusion-related reactions TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.25 [0.01; 5.57]
0.25 [0.01 ; 5.57 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Maculopapular rash TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.50 [0.02; 15.01]
0.50 [0.02 ; 15.01 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Nervous system disorders TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.12 [0.01; 2.36]
0.12 [0.01 ; 2.36 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Pancreatitis TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.50 [0.02; 15.01]
0.50 [0.02 ; 15.01 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Pancytopenia TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.50 [0.02; 15.01]
0.50 [0.02 ; 15.01 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Pericarditis TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.50 [0.02; 15.01]
0.50 [0.02 ; 15.01 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Peripheral neuropathy TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.25 [0.01; 5.57]
0.25 [0.01 ; 5.57 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Pneumonitis TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.12 [0.01; 2.36]
0.12 [0.01 ; 2.36 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Polymyalgia Rheumatica TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 2.01 [0.07; 60.22]
2.01 [0.07 ; 60.22 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Pruritic rash TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 2.01 [0.07; 60.22]
2.01 [0.07 ; 60.22 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Pruritus TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1.01 [0.14; 7.18]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.45 [0.05; 43.54]
1.10 [0.20 ; 6.04 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2 0% 1,237 low not evaluable Rash TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.40 [0.08; 2.07]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.58 [0.07; 4.98]
0.46 [0.12 ; 1.69 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2 0% 1,237 low not evaluable Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.12 [0.01; 2.36]
0.12 [0.01 ; 2.36 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Skin and subcutaneous tissue disorders TRAE (grade 3-4) detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.71 [0.22; 2.27]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.64 [0.14; 3.00]
0.69 [0.27 ; 1.73 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2 0% 1,237 low not evaluable Thyroiditis TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.50 [0.02; 15.01]
0.50 [0.02 ; 15.01 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Uveitis TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 2.01 [0.07; 60.22]
2.01 [0.07 ; 60.22 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1 0% 726 NA not evaluable Vitiligo TRAE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2.91 [0.06; 147.31]
2.91 [0.06 ; 147.31 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1 0% 511 NA not evaluable Abdominal pain AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.97 [0.19; 4.85]
0.97 [0.19 ; 4.85 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1 0% 511 NA not evaluable Anaemia AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.06 [0.33; 3.38]
1.06 [0.33 ; 3.38 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1 0% 511 NA not evaluable Constipation AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2.95 [0.59; 14.78]
2.95 [0.59 ; 14.78 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1 0% 511 NA not evaluable Cough AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.45 [0.05; 43.54]
1.45 [0.05 ; 43.54 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1 0% 511 NA not evaluable Decreased appetite AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.97 [0.19; 4.85]
0.97 [0.19 ; 4.85 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1 0% 511 NA not evaluable Diarrhoea AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.21 [0.49; 2.98]
1.21 [0.49 ; 2.98 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1 0% 511 NA not evaluable Dyspnoea AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.04 [0.37; 2.94]
1.04 [0.37 ; 2.94 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1 0% 511 NA not evaluable Fatigue AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.40 [0.62; 3.18]
1.40 [0.62 ; 3.18 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1 0% 511 NA not evaluable Headache AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2.20 [0.49; 9.98]
2.20 [0.49 ; 9.98 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1 0% 511 NA not evaluable Nausea AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.46 [0.36; 5.93]
1.46 [0.36 ; 5.93 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1 0% 511 NA not evaluable Pyrexia AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.72 [0.03; 16.16]
0.72 [0.03 ; 16.16 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1 0% 511 NA not evaluable Vomiting AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.25 [0.32; 4.90]
1.25 [0.32 ; 4.90 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1 0% 511 NA not evaluable 0.0 5.0 1.0 relative treatment effect www.metaEvidence.org 2024-11-05 18:39 +01:00
TE: relative treatment effect (measured by a risk ratio, an odds ratio or an hazard ratio depending on what is reported in the papers);
k: number of studies; n: total number of patients;
ROB: risk of bias (ROB 2.0); Pub. bias: publication bias; OBS: observational studies; RCT: randomized clinical trials
pathologies: 2,283,284,70,235,285,68,127,128,286,69,129
- treatments: 329,558
