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nivolumab plus ipilimumab (n=425) vs. sunitinib (n=422)
randomized controlled trial
nivolumab plus ipilimumab
nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks
sunitinib
sunitinib 50 mg once daily for 4 weeks, followed by 2 weeks off before continuation of treatment
after the primary end point had been met, permitted crossover from the sunitinib group to thenivolumab-plus-ipilimumab group
metastatic/advanced RCC (mRCC) - 1st line (L1)
patients with intermediate or poor prognostic risk, Additional key inclusion criteria were measurable disease according to RECIST, and a Karnofsky performance-status score of at least 70
open-label
175 sites in 28 countries
P3 / two-sided test procedure with two interim analysis. Repartition alpha between coprimary endpoints (interims analysis) and hierarchy on secondary endpoints (AI positive)
The results suggest that the superior efficacy of nivolumab plus ipilimumab over sunitinib was maintained in intermediate-risk or poor-risk and intention-to-treat patients with extended follow-up, and show the long-term benefits of nivolumab plus ipilimumab in patients with previously untreated advanced renal cell carcinoma across all risk categories.
nivolumab plus ipilimumab (n=125) vs. sunitinib (n=124)
randomized controlled trial
nivolumab plus ipilimumab
nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks
sunitinib
sunitinib 50 mg once daily for 4 weeks, followed by 2 weeks off before continuation of treatment
after the primary end point had been met, permitted crossover from the sunitinib group to thenivolumab-plus-ipilimumab group
metastatic/advanced RCC (mRCC) - 1st line (L1)
patients with favorable prognostic risk, Additional key inclusion criteria were measurable disease according to RECIST, and a Karnofsky performance-status score of at least 70
open-label
175 sites in 28 countries
P3 / two-sided test procedure with two interim analysis. Repartition alpha between coprimary endpoints (interims analysis) and hierarchy on secondary endpoints (AI positive)
The results suggest that the superior efficacy of nivolumab plus ipilimumab over sunitinib was maintained in intermediate-risk or poor-risk and intention-to-treat patients with extended follow-up, and show the long-term benefits of nivolumab plus ipilimumab in patients with previously untreated advanced renal cell carcinoma across all risk categories.
nivolumab plus ipilimumab (n=550) vs. sunitinib (n=546)
randomized controlled trial
nivolumab plus ipilimumab
nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks
sunitinib
sunitinib 50 mg once daily for 4 weeks, followed by 2 weeks off before continuation of treatment
after the primary end point had been met, permitted crossover from the sunitinib group to thenivolumab-plus-ipilimumab group
metastatic/advanced RCC (mRCC) - 1st line (L1)
patients with intermediate, poor or favorable prognostic risk. Additional key inclusion criteria were measurable disease according to RECIST, and a Karnofsky performance-status score of at least 70
open-label
175 sites in 28 countries
P3 / two-sided test procedure with two interim analysis. Repartition alpha between coprimary endpoints (interims analysis) and hierarchy on secondary endpoints (AI positive)
The results suggest that the superior efficacy of nivolumab plus ipilimumab over sunitinib was maintained in intermediate-risk or poor-risk and intention-to-treat patients with extended follow-up, and show the long-term benefits of nivolumab plus ipilimumab in patients with previously untreated advanced renal cell carcinoma across all risk categories.
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