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 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)
mML - 2nd line (L2), ipilimumab alone vs. all, 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]
KEYNOTE-006 (2 week), 2015 (REV) 1.59 [1.19; 2.11]
KEYNOTE-006 (3 week), 2015 (REV) 1.45 [1.10; 1.91]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.96 [0.77; 1.20]
MDX010 Ipi vs gp100, 2010 0.66 [0.51; 0.86]
1.11 [0.85 ; 1.47 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 5 85% 2,652 low not evaluable deaths (OS) (extension)detailed results KEYNOTE-006 (2 week), 2015 (REV) 1.47 [1.15; 1.88]
KEYNOTE-006 (3 week), 2015 (REV) 1.47 [1.15; 1.87]
1.47 [1.24 ; 1.75 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,112 moderate not evaluable PFS (extension)detailed results KEYNOTE-006 (2 week), 2015 (REV) 1.64 [1.34; 2.01]
KEYNOTE-006 (3 week), 2015 (REV) 1.64 [1.34; 2.01]
1.64 [1.42 ; 1.89 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,112 moderate not evaluable progression or deaths (PFS)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1.12 [0.83; 1.52]
KEYNOTE-006 (2 week), 2015 (REV) 1.72 [1.38; 2.16]
KEYNOTE-006 (3 week), 2015 (REV) 1.72 [1.39; 2.13]
1.53 [1.20 ; 1.95 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 3 67% 1,839 moderate 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]
KEYNOTE-006 (2 week), 2015 (REV) 0.27 [0.17; 0.41]
KEYNOTE-006 (3 week), 2015 (REV) 0.28 [0.18; 0.43]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2.03 [1.03; 4.02]
MDX010 Ipi vs gp100, 2010 8.24 [1.85; 36.76]
0.82 [0.34 ; 1.96 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 5 92% 2,652 low not evaluable AE (any grade)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.51 [0.14; 1.83]
MDX010 Ipi vs gp100, 2010 0.99 [0.24; 4.05]
0.69 [0.27 ; 1.78 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 2 0% 774 low not evaluable AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.01 [0.68; 1.51]
MDX010 Ipi vs gp100, 2010 0.95 [0.59; 1.55]
0.99 [0.73 ; 1.34 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 2 0% 774 low not evaluable STRAE (any grade)detailed results KEYNOTE-006 (2 week), 2015 (REV) 1.49 [0.92; 2.42]
KEYNOTE-006 (3 week), 2015 (REV) 1.59 [0.97; 2.60]
1.54 [1.09 ; 2.17 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate not evaluable STRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
1.08 [0.07 ; 17.38 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate not evaluable TRAE (any grade)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.42 [0.31; 0.57]
KEYNOTE-006 (2 week), 2015 (REV) 0.62 [0.41; 0.93]
KEYNOTE-006 (3 week), 2015 (REV) 0.86 [0.58; 1.28]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.50 [0.29; 0.86]
MDX010 Ipi vs gp100, 2010 1.09 [0.60; 1.98]
0.64 [0.45 ; 0.90 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 5 69% 2,567 low not evaluable TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.37 [0.25; 0.54]
KEYNOTE-006 (2 week), 2015 (REV) 1.19 [0.77; 1.85]
KEYNOTE-006 (3 week), 2015 (REV) 1.22 [0.78; 1.90]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.86 [0.50; 1.48]
MDX010 Ipi vs gp100, 2010 1.41 [0.69; 2.88]
0.90 [0.52 ; 1.54 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 5 84% 2,567 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]
KEYNOTE-006 (2 week), 2015 (REV) 0.54 [0.02; 16.23]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
0.56 [0.14 ; 2.32 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 3 0% 1,793 low 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]
KEYNOTE-006 (2 week), 2015 (REV) 1.35 [0.71; 2.53]
KEYNOTE-006 (3 week), 2015 (REV) 0.81 [0.46; 1.44]
0.78 [0.44 ; 1.39 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 3 74% 1,793 moderate 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]
KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
0.45 [0.30 ; 0.66 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 3 0% 1,793 low not evaluable Abdominal pain TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
1.08 [0.07 ; 17.38 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate 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]
MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17]
0.70 [0.10 ; 5.04 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 3 0% 1,500 low not evaluable Alopecia TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
1.08 [0.07 ; 17.38 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate not evaluable Anaemia TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 0.54 [0.05; 6.00]
KEYNOTE-006 (3 week), 2015 (REV) 2.17 [0.07; 64.92]
0.86 [0.12 ; 6.13 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate not evaluable Arthralgia TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
1.08 [0.07 ; 17.38 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate not evaluable Asthenia TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 2.18 [0.20; 24.20]
KEYNOTE-006 (3 week), 2015 (REV) 4.35 [0.20; 97.02]
2.83 [0.42 ; 18.94 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate not evaluable Chills TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
1.08 [0.07 ; 17.38 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate not evaluable Colitis TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.46 [0.21; 1.04]
KEYNOTE-006 (2 week), 2015 (REV) 5.18 [1.73; 15.52]
KEYNOTE-006 (3 week), 2015 (REV) 2.92 [1.20; 7.11]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.73 [0.67; 4.49]
MDX010 Ipi vs gp100, 2010 14.85 [0.83; 264.38]
2.17 [0.78 ; 6.04 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 5 77% 2,567 low not evaluable Constipation TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
1.08 [0.07 ; 17.38 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate not evaluable Cough TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
1.08 [0.07 ; 17.38 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate not evaluable Decreased appetite TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
1.08 [0.07 ; 17.38 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate not evaluable Diabetes TRAE (grade 3-4)detailed results KEYNOTE-006 (3 week), 2015 (REV) 0.54 [0.02; 16.17]
0.54 [0.02 ; 16.17 ] KEYNOTE-006 (3 week), 2015 (REV) 1 0% 533 NA not evaluable Diarrhoea TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.54 [0.31; 0.95]
KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.38; 3.15]
KEYNOTE-006 (3 week), 2015 (REV) 2.57 [0.66; 10.04]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.25 [0.47; 3.34]
MDX010 Ipi vs gp100, 2010 6.29 [0.75; 52.98]
1.22 [0.59 ; 2.51 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 5 56% 2,567 low serious Dry skin TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
1.08 [0.07 ; 17.38 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate not evaluable Dyspnoea TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 2.18 [0.07; 65.16]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.07; 17.40]
1.43 [0.17 ; 12.30 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate 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]
MDX010 Ipi vs gp100, 2010 10.44 [0.56; 193.00]
1.92 [0.29 ; 12.94 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 3 80% 1,500 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 Fatigue TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 3.28 [0.34; 31.78]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.22; 5.41]
1.57 [0.42 ; 5.83 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate 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]
MDX010 Ipi vs gp100, 2010 10.83 [1.37; 85.84]
1.36 [0.42 ; 4.35 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 3 80% 1,500 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 Headache TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
1.08 [0.07 ; 17.38 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate not evaluable Hepatitis TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.40 [0.08; 2.07]
KEYNOTE-006 (2 week), 2015 (REV) 0.36 [0.04; 3.48]
KEYNOTE-006 (3 week), 2015 (REV) 0.21 [0.02; 1.84]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.45 [0.05; 43.54]
MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17]
0.41 [0.14 ; 1.15 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 5 0% 2,567 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]
MDX010 Ipi vs gp100, 2010 0.16 [0.01; 3.32]
0.25 [0.03 ; 2.01 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 2 0% 774 low 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 Hyperthyroidism TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 2.18 [0.07; 65.16]
KEYNOTE-006 (3 week), 2015 (REV) 2.17 [0.07; 64.92]
2.17 [0.20 ; 24.03 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate not evaluable Hypophysitis TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.70 [0.26; 1.85]
KEYNOTE-006 (2 week), 2015 (REV) 4.37 [0.20; 97.37]
KEYNOTE-006 (3 week), 2015 (REV) 2.17 [0.20; 24.11]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2.93 [0.41; 21.02]
MDX010 Ipi vs gp100, 2010 4.08 [0.18; 91.29]
1.22 [0.56 ; 2.63 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 5 0% 2,567 low serious Hypothyroidism TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.50 [0.02; 15.01]
KEYNOTE-006 (2 week), 2015 (REV) 0.54 [0.02; 16.23]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.45 [0.05; 43.54]
MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17]
0.83 [0.17 ; 4.10 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 5 0% 2,567 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]
KEYNOTE-006 (2 week), 2015 (REV) 4.37 [0.20; 97.37]
KEYNOTE-006 (3 week), 2015 (REV) 2.17 [0.20; 24.11]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.45 [0.05; 43.54]
MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17]
0.86 [0.21 ; 3.56 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 5 21% 2,567 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]
KEYNOTE-006 (2 week), 2015 (REV) 4.37 [0.20; 97.37]
KEYNOTE-006 (3 week), 2015 (REV) 2.17 [0.20; 24.11]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.72 [0.03; 16.16]
MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17]
0.71 [0.18 ; 2.78 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 5 29% 2,567 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]
KEYNOTE-006 (2 week), 2015 (REV) 2.18 [0.07; 65.16]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.07; 17.40]
1.06 [0.17 ; 6.53 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 3 0% 1,793 moderate not evaluable Myalgia TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.07; 17.46]
KEYNOTE-006 (3 week), 2015 (REV) 2.17 [0.07; 64.92]
1.43 [0.17 ; 12.31 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate not evaluable Myositis TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
1.08 [0.07 ; 17.38 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate not evaluable Nausea TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
1.08 [0.07 ; 17.38 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate not evaluable Nephritis TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 2.18 [0.07; 65.16]
KEYNOTE-006 (3 week), 2015 (REV) 2.17 [0.07; 64.92]
2.17 [0.20 ; 24.03 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate 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 Neutropenia TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
1.08 [0.07 ; 17.38 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate 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 Paraesthesia TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 2.18 [0.07; 65.16]
KEYNOTE-006 (3 week), 2015 (REV) 2.17 [0.07; 64.92]
2.17 [0.20 ; 24.03 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate 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]
KEYNOTE-006 (2 week), 2015 (REV) 2.18 [0.07; 65.16]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.07; 17.40]
0.61 [0.11 ; 3.47 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 3 0% 1,793 moderate 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]
KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
1.39 [0.16 ; 11.91 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 3 0% 1,793 moderate not evaluable Pruritus TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 1.01 [0.14; 7.18]
KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.45 [0.05; 43.54]
MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17]
1.09 [0.28 ; 4.24 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 5 0% 2,567 low not evaluable Pyrexia TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
1.08 [0.07 ; 17.38 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate not evaluable Rash TRAE (grade 3-4)detailed results Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV) 0.40 [0.08; 2.07]
KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.58 [0.07; 4.98]
MDX010 Ipi vs gp100, 2010 2.02 [0.07; 60.83]
0.62 [0.20 ; 1.89 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 5 0% 2,567 low serious 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]
MDX010 Ipi vs gp100, 2010 4.08 [0.18; 91.29]
0.79 [0.33 ; 1.93 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 3 0% 1,500 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]
KEYNOTE-006 (2 week), 2015 (REV) 1.09 [0.02; 54.94]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
1.39 [0.16 ; 11.91 ] Ascierto (ipi 10 vs 3 mg/kg), 2017 (REV), KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 3 0% 1,793 moderate not evaluable Vitiligo TRAE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2.91 [0.06; 147.31]
MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17]
1.71 [0.11 ; 27.50 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 2 0% 774 low not evaluable Vomiting TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 0.54 [0.02; 16.23]
KEYNOTE-006 (3 week), 2015 (REV) 1.08 [0.02; 54.74]
0.73 [0.06 ; 9.52 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate not evaluable Weight decreased TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 (REV) 2.18 [0.07; 65.16]
KEYNOTE-006 (3 week), 2015 (REV) 2.17 [0.07; 64.92]
2.17 [0.20 ; 24.03 ] KEYNOTE-006 (2 week), 2015 (REV), KEYNOTE-006 (3 week), 2015 (REV) 2 0% 1,067 moderate 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]
MDX010 Ipi vs gp100, 2010 0.28 [0.06; 1.36]
0.51 [0.15 ; 1.75 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 2 15% 774 low not evaluable Anaemia AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.06 [0.33; 3.38]
MDX010 Ipi vs gp100, 2010 0.35 [0.11; 1.12]
0.61 [0.20 ; 1.81 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 2 43% 774 low not evaluable Constipation AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2.95 [0.59; 14.78]
MDX010 Ipi vs gp100, 2010 3.07 [0.32; 29.91]
2.99 [0.80 ; 11.14 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 2 0% 774 low not evaluable Cough AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.45 [0.05; 43.54]
MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17]
1.24 [0.09 ; 16.24 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 2 0% 774 low 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]
MDX010 Ipi vs gp100, 2010 0.50 [0.09; 2.76]
0.71 [0.22 ; 2.29 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 2 0% 774 low not evaluable Diarrhoea AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.21 [0.49; 2.98]
MDX010 Ipi vs gp100, 2010 7.40 [0.90; 60.98]
2.30 [0.42 ; 12.63 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 2 58% 774 low not evaluable Dyspnoea AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.04 [0.37; 2.94]
MDX010 Ipi vs gp100, 2010 0.83 [0.25; 2.80]
0.95 [0.43 ; 2.08 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 2 0% 774 low not evaluable Fatigue AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.40 [0.62; 3.18]
MDX010 Ipi vs gp100, 2010 2.36 [0.71; 7.87]
1.65 [0.84 ; 3.25 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 2 0% 774 low not evaluable Headache AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 2.20 [0.49; 9.98]
MDX010 Ipi vs gp100, 2010 1.01 [0.20; 5.09]
1.53 [0.51 ; 4.62 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 2 0% 774 low not evaluable Nausea AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.46 [0.36; 5.93]
MDX010 Ipi vs gp100, 2010 1.01 [0.20; 5.09]
1.25 [0.43 ; 3.59 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 2 0% 774 low not evaluable Pyrexia AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 0.72 [0.03; 16.16]
MDX010 Ipi vs gp100, 2010 0.25 [0.01; 5.58]
0.42 [0.05 ; 3.82 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 2 0% 774 low not evaluable Vomiting AE (grade 3-4)detailed results MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV) 1.25 [0.32; 4.90]
MDX010 Ipi vs gp100, 2010 1.01 [0.20; 5.09]
1.14 [0.40 ; 3.25 ] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 (REV), MDX010 Ipi vs gp100, 2010 2 0% 774 low not evaluable 0.0 5.0 1.0 relative treatment effect www.metaEvidence.org 2024-06-14 19:07 +02:00
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: 286,69,129
- treatments: 329,558
