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nivolumab plus ipilimumab (n=95) vs. ipilimumab alone (n=47)
randomized controlled trial
nivolumab and ipilimumab
nivolumab (1 mg per kilogram) and ipilimumab (3 mg per kilogram of body weight) combined once every 3 weeks for four doses followed by nivolumab (3 mg per kilogram) every 2 weeks until the occurrence of disease progression or unacceptable toxic effects
ipilimumab
ipilimumab (3 mg per kilogram of body weight) combined once every 3 weeks, nivolumab was replaced with matched placebo during both the combination and maintenance portions of the trial.
After the fourth dose of both agents, ipilimumab was discontinued, and thereafter (maintenance phase), nivolumab was administered as a single agent at a dose of 3 mg per kilogram over a period of 60 minutes, once every 2 weeks.
mML - L1 - all population
Other inclusion criteria included a known BRAF V600 mutation status and the availability for immunohistochemical assessment of PD-1 ligand (PD-L1) expression.
double-blind
United States and France
P2/ two sided test procedure without interim analysis. The primary end point was the rate of investigator-assessed, confirmed objective response among patients with BRAF V600 wild-type tumors. In order to preserve an experiment-wide type I error rate of 5%, a hierarchical testing approach was applied to key secondary end points safety in all randomized population (BRAF mutant and wild type). A hierarchical testing approach was applied to key secondary end points : ORR WT then ORR ITT then PFS WT then PFS ITTNo statistical analysis planned for BRAF mutant population
The objective-response rate and the progression-free survival among patients with advanced melanoma who had not previously received treatment were significantly greater with nivolumab combined with ipilimumab than with ipilimumab monotherapy. (in BRAFwild and all population)
nivolumab plus ipilimumab (n=314) vs. ipilimumab alone (n=315)
randomized controlled trial
nivolumab plus ipilimumab
nivolumab at a dose of 1 mg per kilogram of body weight every 3 weeks plus ipilimumab at adose of 3 mg per kilogram every 3 weeks for four doses, followed by nivolumab at a dose of3 mg per kilogram every 2 weeks
ipilimumab
ipilimumab at a dose of 3 mg per kilogram every 3 weeks for four doses (plus nivolumab-matched placebo).
Treatment was continued until disease progression, the occurrence of unacceptable toxicevents, or withdrawal of consent.
mML - L1 - all population
Adults, with 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 plus ipilimumab (n=314) vs. nivolumab alone (n=316)
randomized controlled trial
nivolumab plus ipilimumab
nivolumab at a dose of 1 mg per kilogram of body weight every 3 weeks plus ipilimumab at adose of 3 mg per kilogram every 3 weeks for four doses, followed by nivolumab at a dose of3 mg per kilogram every 2 weeks
nivolumab
nivolumab at a dose of 3 mg per kilogram every 2 weeks (plus ipilimumab-matched placebo);
Treatment was continued until disease progression, the occurrence of unacceptable toxicevents, or withdrawal of consent.
mML - L1 - all population
Adults, with 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: hierarchical testing procedure and repartition : OS 0.02/ARM (N vs I, NI vs I), PFS 0.005/ARM (N vs I, NI vs I), ORR (N vs I, NI vs I) => exploratory for NI vs N
Nivolumab alone or combined with ipilimumab improved progression-free survival (no threshold), as compared with ipilimumab, among previously untreated patients with metastatic melanoma
nivolumab plus ipilimumab (n=23) vs. ipilimumab alone (n=10)
randomized controlled trial
nivolumab and ipilimumab
nivolumab (1 mg per kilogram) and ipilimumab (3 mg per kilogram of body weight) combined once every 3 weeks for four doses followed by nivolumab (3 mg per kilogram) every 2 weeks until the occurrence of disease progression or unacceptable toxic effects
ipilimumab
ipilimumab (3 mg per kilogram of body weight) combined once every 3 weeks, nivolumab was replaced with matched placebo during both the combination and maintenance portions of the trial.
After the fourth dose of both agents, ipilimumab was discontinued, and thereafter (maintenance phase), nivolumab was administered as a single agent at a dose of 3 mg per kilogram over a period of 60 minutes, once every 2 weeks.
mML - L1 - BRAF mutant
Other inclusion criteria included a known BRAF V600 mutation status and the availability for immunohistochemical assessment of PD-1 ligand (PD-L1) expression
double-blind
United States and France
P2/ two sided test procedure without interim analysis. The primary end point was the rate of investigator-assessed, confirmed objective response among patients with BRAF V600 wild-type tumors. In order to preserve an experiment-wide type I error rate of 5%, a hierarchical testing approach was applied to key secondary end points. a hierarchical testing approach was applied to key secondary end points : ORR WT then ORR ITT then PFS WT then PFS ITTNo statistical analysis planned for BRAF mutant population
The objective-response rate and the progression-free survival among patients with advanced melanoma who had not previously received treatment were significantly greater with nivolumab combined with ipilimumab than with ipilimumab monotherapy.
nivolumab plus ipilimumab (n=72) vs. ipilimumab alone (n=37)
randomized controlled trial
nivolumab and ipilimumab
nivolumab (1 mg per kilogram) and ipilimumab (3 mg per kilogram of body weight) combined once every 3 weeks for four doses followed by nivolumab (3 mg per kilogram) every 2 weeks until the occurrence of disease progression or unacceptable toxic effects
ipilimumab
ipilimumab (3 mg per kilogram of body weight) combined once every 3 weeks, nivolumab was replaced with matched placebo during both the combination and maintenance portions of the trial.
After the fourth dose of both agents, ipilimumab was discontinued, and thereafter (maintenance phase), nivolumab was administered as a single agent at a dose of 3 mg per kilogram over a period of 60 minutes, once every 2 weeks.
mML - L1 - BRAF wild
Other inclusion criteria included a known BRAF V600 mutation status, and the availability for immunohistochemical assessment of PD-1 ligand (PD-L1) expression.
double-blind
United States and France
P2/ two sided test procedure without interim analysis. The primary end point was the rate of investigator-assessed, confirmed objective response among patients with BRAF V600 wild-type tumors. In order to preserve an experiment-wide type I error rate of 5%, a hierarchical testing approach was applied to key secondary end points. A hierarchical testing approach was applied to key secondary end points : ORR WT then ORR ITT then PFS WT then PFS ITTNo statistical analysis planned for BRAF mutant population
The objective-response rate and the progression-free survival among patients with advanced melanoma who had not previously received treatment were significantly greater with nivolumab combined with ipilimumab than with ipilimumab monotherapy. (in BRAFwild and all population)
nivolumab plus ipilimumab (n=-9) vs. nivolumab alone (n=-9)
randomized controlled trial
nivolumab plus ipilimumab
240 mg of nivolumab intravenously every 2 weeks and 1 mg/kg of ipilimumab every 6 weeks for up to 1 year.
nivolumab
480 mg of nivolumab every 4 weeks for up to 1 year.
mML - NA - all population
double-blind
P3/
Qualitative results realeased in BMS news in october 2020 : Statistically significant benefit was not reached for the co-primary endpoint of recurrence-free survival (RFS) in patients whose tumors expressed PD-L1 <1% (2019 results) and in the all-comer (intent-to-treat) (2020 results).
nivolumab plus ipilimumab (n=56) vs. nivolumab alone (n=59)
randomized controlled trial
nivolumab plus ipilimumab
nivolumab plus ipilimumab group (1 mg/kg of intravenous nivolumab every 3 weeks plus 3 mg/kg of intravenous ipilimumab every 3 weeks for four doses, followed by 3 mg/kg of nivolumab every 2 weeks)
nivolumab
3 mg/kg of nivolumab every 2 weeks (plus ipilimumab-matching placebo during weeks 1–12
For patients with disease recurrence receiving nivolumab-matching placebo plus ipilimumabmatching placebo, crossover to nivolumab was allowed
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 )
exploratory results only
nivolumab plus ipilimumab (n=56) vs. placebo (n=52)
randomized controlled trial
nivolumab plus ipilimumab
nivolumab plus ipilimumab group (1 mg/kg of intravenous nivolumab every 3 weeks plus 3 mg/kg of intravenous ipilimumab every 3 weeks for four doses, followed by 3 mg/kg of nivolumab every 2 weeks)
placebo
double-matching placebo group
For patients with disease recurrence receiving nivolumab-matching placebo plus ipilimumabmatching placebo, crossover to nivolumab was allowed
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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