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nivolumab plus ipilimumab (n=303) vs. pemetrexed plus platin (n=302)
randomized controlled trial
nivolumab plus ipilimumab
nivolumab (3 mg/kg intravenous infusion once every 2 weeks) plus ipilimumab (1 mg/kg intravenous infusion once every 6 weeks).
cisplatin or carboplatin plus pemetrexed
intravenous infusion of cisplatin (75 mg/m²) or carboplatin (area under the concentrationtimecurve 5 mg/mL per min) plus pemetrexed (500 mg/m²) every 3 weeks for a maximum of six cycles.
both treatment groups were pretreated with folic acid (350–1000 μg orally daily) and vitamin B12(1000 μg intramuscularly) 1 week before administration.Dose reductions were permitted for chemotherapy, but not for nivolumab or ipilimumab; cross-over is not allowed in this study
malignant mesothelioma (mMS) - 1st line (L1)
open label
103 hospitals across 21 countries
P3/ two sided and one interim analysis for OS. No formal statistical testing or allocation of alpha values for progression-free survival, objective response rate, and disease control rate
AI1 stop : Nivolumab in combination with ipilimumab significantly improved overall survival (OS) in treatment-naïve patients with unresectable malignant pleural mesothelioma (MPM) who were treated in the phase 3 CheckMate 743 clinical trial.
nivolumab alone (n=211) vs. placebo (n=111)
randomized controlled trial
nivolumab
nivolumab at a dose of 240 mg as a 30-min intravenous (IV) infusion, on day 1 ± 2 Q2W
placebo
placebo : sterile 0.9% sodium chloride as a 30-min IV infusion
There will be no dose escalations or reductions allowed.
malignant mesothelioma (mMS) - 2nd line (L2)
double-blind
approximately 25 UK centres
P3/
Results showed that the trial met both its coprimary end points of overall survival (OS) and progression-free survival (PFS)
tremelimumab (n=382) vs. placebo (n=189)
randomized controlled trial
tremelimumab
tremelimumab (intravenous infusion at 10 mg/kg) , every 4 weeks for seven doses as induction treatment, followed by maintenance dosing every 12 weeks
placebo
tremelimumab matching placebo, every 4 weeks for seven doses as induction treatment, followed by maintenance dosing every 12 weeks
cross over was permitted for placebo arm in accordance with protocol eligibility criteria.No dose reductions were allowed
malignant mesothelioma (mMS) - 2nd line (L2)
Patients with any histological subtypes of malignant mesothelioma (epithelioid,sarcomatoid, and biphasic) were allowed to participate.
double-blind
105 study centres across 19 countries
A hierarchical gate-keeping strategy was applied in this study, OS then secondary endpoint
Tremelimumab did not significantly prolong overall survival compared with placebo in patients with previously treated malignant mesothelioma.
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