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nivolumab alone (n=316) vs. ipilimumab alone (n=315)
randomized controlled trial
nivolumab
nivolumab at a dose of 3 mg per kilogram every 2 weeks (plus ipilimumab-matched placebo)
ipilimumab
ipilimumab at a dose of 3 mg per kilogram every 3 weeks for four doses (plus nivolumab-matched placebo)
mML - L1 - all population
Other eligibility criteria included known BRAF V600 mutation status
double-blind
137 cancer centres in 21 countries
P3/ two sided test procedure without interim analysis (but OS prolonged) (efficacy endpoints were based on the intent-to-treat population and formal co-primary endpoint analyses were conducted at two different prespecified time points (separately for progression-free survival and overall survival) per the study protocol, as described previously)3 arms // repartition : OS 0.02/ARM (N vs I, NI vs I), PFS 0.005/ARM (N vs I, NI vs I), and hierarchical testing procedure for ORR with PFS results (N vs I, NI vs I)
Nivolumab alone or combined with ipilimumab improved progression-free survival (no threshold), as compared with ipilimumab, among previously untreated patients with metastatic melanoma
nivolumab alone (n=210) vs. dacarbazine (n=208)
randomized controlled trial
nivolumab
Nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks, plus a dacarbazine-matched placebo every 3 weeks
dacarbazine
1000 mg of dacarbazine per square meter of body-surface area every 3 weeks, plus a nivolumab-matched placebo every 2 weeks.
Treatment continued until there was disease progression, as assessed by the investigator, or an unacceptable level of toxic effects. As a result, the monitoring committee recommended that the study be unblinded and amended to allow patients enrolled in the dacarbazine group to receive nivolumab.
mML - L1 - BRAF wild
exclusion criteria were active brain metastases, ans patients who had received adjuvant therapy previously were not excluded.
double-blind
Europe, Israel, Australia, Canada, and South America
P3/ two sided test procedure with interim analysis. Hierarchy OS then PFS then ORR
Nivolumab was associated with significant improvements in overall survival and progression-free survival, as compared with dacarbazine, among previously untreated patients who had metastatic melanoma without a BRAF mutation
nivolumab alone (n=272) vs. Standard of Care (SoC) (n=133)
randomized controlled trial
nivolumab
nivolumab 3 mg/kg every 2 weeks until progression or unacceptable toxic effects. We allowed treatment with nivolumab beyond progression for patients experiencing clinical benefit and tolerating the drug as established by the investigator.
chemotherapy (investigator’s choice)
dacarbazine 1000 mg/m² every 3 weeks or paclitaxel 175 mg/m² combined with carboplatin area under the curve 6 every 3 weeks). (dacarbazine,33.8%; paclitaxel,42.9%) Treatment was given open-label because of the choices available to the investigators in the ICC group
We did not allow dose reductions with nivolumab treatment (dose reductions for chemotherapy were per institutional standards of care); however, we allowed dose delays
mML - L2 - all population
patients with active brain metastases and individuals who had had previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies;were excluded
open-label
90 sites in 14 countries
P3/ two sided test procedure with one interim analysis. Repartition between coprimary endpoint, and hierarchy for secondary endpoints
Nivolumab demonstrated higher, more durable responses but no difference in survival compared with ICC.
nivolumab alone (n=453) vs. Ipilimumab (10 mg/kg) (n=453)
randomized controlled trial
nivolumab
nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks
ipilimumab
ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses and then every 12 weeks
traetment along with corresponding matching placebo
mML - NA - all population
double-blind
130 centers in 25 countries
P3/ two sided test procedure with one interim analysis. The critical hazard ratio was 0.78 with an adjusted alpha level of 0.0244 (two-sided). (no other strategy in SAP)
Among patients undergoing resection of stage IIIB, IIIC, or IV melanoma, adjuvant therapy with nivolumab resulted in significantly longer recurrence-free survival and a lower rate of grade 3 or 4 adverse events than adjuvant therapy with ipilimumab
nivolumab alone (n=59) vs. placebo (n=52)
randomized controlled trial
nivolumab
nivolumab monotherapy group (3 mg/kg of intravenous nivolumab every 2 weeks plus ipilimumab-matching placebo during weeks 1–12)
placebo
double-matching placebo group
mML - NA - all population
double-blind
20 german academic medical centres
P2/ two sided and one interim analysis. Repartition alpha between two arms (0.025/arm) (nivolumab plus ipilimumab and nivolumab versus placebo) no statistical plan for the comparaison between nivolumab plus ipilimumab and nivolumab )
Adjuvant therapy with nivolumab alone or in combination with ipilimumab increased recurrence-free survival significantly compared with placebo in patients with stage IV melanoma with no evidence of disease
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