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atezolizumab alone (n=-9) vs. placebo (n=-9)
randomized controlled trial
Atezolizumab
Placebo
metastatic/advanced RCC (mRCC) - (neo)adjuvant(NA)
double-blind
nivolumab alone (n=-9) vs. nivolumab plus ipilimumab (n=-9)
randomized controlled trial
Nivolumab plus ipilimumab
Placebo
metastatic/advanced RCC (mRCC) - (neo)adjuvant(NA)
double-blind
Phase 3 CheckMate -914 trial, evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab), as adjuvant treatment of localized renal cell carcinoma or RCC, did not meet the primary endpoint.
pembrolizumab alone (n=496) vs. placebo (n=498)
randomized controlled trial
pembrolizumab
pembrolizumab: IV 200 mg every 3 weeks
placebo
placebo: IV every 3 weeks
metastatic/advanced RCC (mRCC) - (neo)adjuvant(NA)
Exclusion criteria: no prior systemic therapy
double-blind
213 sites in 21 countries (Asia, Australia, Europe, North and South America)
P3 / DFS at 0.025 at 1-sided (with 1IA: p=0.0122, final: p=0.0214), if significant then OS at 0.025 at 1-sided(with 3IA, 1st: p=0.0011, 2nd=0.0055, 3rd: p=0.0138 and final: p=0.0200)
atezolizumab alone (n=103) vs. sunitinib (n=101)
randomized controlled trial
atezolizumab
atezolizumab 1,200mg fixed intravenous dose every three weeks
sunitinib
sunitinib 50mg/d orally for four weeks followed by two weeks of rest
3 bras : atezolizumab, atezolizumab and bevacizumab, sunitinib, patients randomized to atezolizumab monotherapy or sunitinib had the option to cross over and receive the atezolizumab bevacizumab combination in some regions
metastatic/advanced RCC (mRCC) - 1st line (L1)
patients had a Karnofsky performance score ≥ 70, . Patients were required to have adequate hematologic and end-organ function.
open-label
96 institution
P2/interim analysis planned but no treshhold, no stratistic plan found (no protocol)
Overall, data from IMmotion150 suggest (did not demonstrare PFS benefit) that atezolizumab plus bevacizumab may particularly enhance PFS benefit in patients with pre-existing antitumor immunity (as determined by a high Teff score and PD-L1 IC expression) compared with sunitinib
atezolizumab plus bevacizumab (n=101) vs. sunitinib (n=101)
randomized controlled trial
atezolizumab with bevacizumab
atezolizumab 1,200mg fixed intravenous dose bevacizumab 15mg/kg every three weeks
sunitinib
sunitinib 50mg/d orally for four weeks followed by two weeks of rest
3 bras : atezolizumab, atezolizumab and bevacizumab, sunitinibpatients randomized to atezolizumab monotherapy or sunitinib had the option to cross over and receive the atezolizumab bevacizumab combination in some regions
metastatic/advanced RCC (mRCC) - 1st line (L1)
patients had a Karnofsky performance score ≥ 70, . Patients were required to have adequate hematologic and end-organ function.
open-label
96 institution
P2/interim analysis planned but no treshhold, no stratistic plan found (no protocol)
Overall, data from IMmotion150 suggest (did not demonstrare PFS benefit) that atezolizumab plus bevacizumab may particularly enhance PFS benefit in patients with pre-existing antitumor immunity (as determined by a high Teff score and PD-L1 IC expression) compared with sunitinib
atezolizumab plus bevacizumab (n=454) vs. sunitinib (n=461)
randomized controlled trial
atezolizumab plus bevacizumab
atezolizumab 1200 mg intravenously then bevacizumab 15 mg/kg intravenous infusions once every 3 weeks.
Sunitinib
sunitinib 50 mg once daily orally for 4 weeks, followed by 2 weeks of rest
No prespecified crossover was planned per protocol. Patients could continue atezolizumab plus bevacizumab or sunitinib
metastatic/advanced RCC (mRCC) - 1st line (L1)
Patients were excluded if they had received previous systemic treatment or if they had untreated brain metastases.
open label
152 sites across 21 countries
P3 / two-sided test procedure with two interim analysis. AI 1 (12 months) repartition between coprmary endpoints (0.04 PFS and 0.01 OS) and then hierarchy with OS (PDL1>1%)
Atezolizumab plus bevacizumab did not significantly prolonged progression-free survival versus sunitinib in patients with metastatic renal cell carcinoma but showed a favourable safety profile.
avelumab plus axitinib (n=442) vs. sunitinib (n=444)
randomized controlled trial
Avelumab plus Axitinib
Avelumab was administered at a dose of 10 mg per kilogram of body weight as a 1-hour intravenous infusion every 2 weeks, Axitinib was administered orally at a starting dose of 5 mg twice daily on a continuous dosing schedule.An antihistamine and acetaminophen were administered approximately 30 to 60 minutes before each infusion.
Sunitinib
Sunitinib was administered at a dose of 50 mg orally once daily for 4 weeks of an 6-week cycle.
Dose reductions of avelumab were not permitted, but subsequent infusions could be omitted in response to persisting toxic effects. Dose escalations and reductions of axitinib and dose reductions of sunitinib are described in the protocol
metastatic/advanced RCC (mRCC) - 1st line (L1)
patients with IMDC and MSKCC prognostic risk groups were included.Key exclusioncriteria included active central nervous system metastases
open label
144 sites in 21 countries
P3 /one sided test procedure with one interim analysis . Repartition between coprimary endpoints (0.004/0.021) and hierarchical testing procedure with secondary endpoints
Progression-free survival was significantly longer with avelumab plus axitinib than withsunitinib among patients who received these agents as first-line treatment for advancedrenal-cell carcinoma (ITT and PDL1>1%)
nivolumab plus cabozantinib (n=323) vs. sunitinib (n=328)
randomized controlled trial
Nivolumab and Cabozantinib
nivolumab 240 mg every 2 weeks plus oral cabozantinib 40 mg daily
Sunitinib
oral sunitinib 50 mg daily in cycles of 4 weeks on therapy/2 weeks off therapy
metastatic/advanced RCC (mRCC) - 1st line (L1)
Patients had any InternationalMetastatic Renal-Cell Carcinoma DatabaseConsortium (IMDC) prognostic risk score18,19 anda Karnofsky performance-status score of at least70 (on a scale from 0 to 100
open label
125 sites in 18 countries
P3/ two sided and two interim analyses (OS). If the between-group difference inprogression-free survival was significant, analysisof overall survival would be performed at an overall alpha level of 0.05 (0.011 at the first interim, 0.025at the second interim, and 0.041 at the finalanalysis with an O’Brien and Fleming alphaspending function). and then ORR with the use of a hierarchicaltesting procedure.
Nivolumab plus cabozantinib had significant benefits over sunitinib with respect to progression-free survival, overall survival, and likelihood of response in patients with previously untreated advanced renal-cell carcinoma.
pembrolizumab plus axitinib (n=432) vs. sunitinib (n=429)
randomized controlled trial
pembrolizumab plus axitinib
pembrolizumab was administred at a dose of 200 mg once every 3 weeks. Axitinib was administered orally at a dose of 5 mg twice daily, the dose could be increased to 7 mg,then 10 mg, twice daily if safety criteria were met and reduced to 3 mg, then 2 mg, twice daily to manage toxic effects
sunitinib
Sunitinib was administered orally at a dose of 50 mg daily for the first 4 weeks of each 6-week cycle the dose could be reduced to 37.5 mg, then 25 mg, for the first 4 weeks of each 6-week cycle to manage toxic effects.
metastatic/advanced RCC (mRCC) - 1st line (L1)
First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma
open-label
129 sites in 16 countries
P3 / one-sided test procedure with TWO interim analysis. Repartition between coprimary endpoints, and hierarchy with ORR
Among patients with previously untreated advanced renal-cell carcinoma, treatmentwith pembrolizumab plus axitinib resulted in significantly longer overall survival andprogression-free survival, as well as a higher objective response rate, than treatmentwith sunitinib.
pembrolizumab plus lenvatinib (n=355) vs. sunitinib (n=357)
randomized controlled trial
lenvatinib plus pembrolizumab
LENVIMA (20 mg orally once daily) in combination with KEYTRUDA (200 mg intravenously every three weeks)
sunitinib
Sunitinib (50 mg orally once daily for four weeks on treatment, followed by two weeks off treatment)
3 arms : lenvatinib plus pembrolizumab, lenvatinib plus everolimus and sunitinib
metastatic/advanced RCC (mRCC) - 1st line (L1)
Karnofsky performance-status scoreof at least 70
open label
200 sites in 20 countries
P3/ two sided and two interim analysis. A sequential approach for multiple comparisons was used to adjust for multiplicity and to control the familywise error rate for progression-free survival and overall survival and the percentage of patients with an objective responseat the alpha of 0.0499 (two-sided) in comparisonsof each combination regimen with sunitinib.
The combination of pembrolizumab (Keytruda) plus lenvatinib (Lenvima) significantly improved progression-free survival (PFS), overall survival (OS), and the objective response rate (ORR) compared with sunitinib (Sutent) as first line in patient with advancedrenal cell carcinoma
atezolizumab plus cabozantinib (n=263) vs. cabozantinib (n=259)
randomized controlled trial
atezolizumab plus cabozantinib
atezolizumab (1200 mg intravenously every 3 weeks) plus cabozantinib (60 mg orally once daily)
cabozantinib alone
cabozantinib (60 mg orally once daily) cabozantinib (60 mg orally once daily)
metastatic/advanced RCC (mRCC) - 2nd line (L2)
open-label
135 study sites in 15 countries in Asia, Europe, North America, and South America
nivolumab alone (n=410) vs. everolimus (n=411)
randomized controlled trial
nivolumab
3 mg of nivolumab per kilogram of body weight intravenously every 2 weeks
everolimus
10-mg everolimus tablet orally once daily
Dose modifications were not permitted for nivolumab but were permitted for everolimus
metastatic/advanced RCC (mRCC) - 2nd line (L2)
Key exclusion criteria were metastasis to the central nervous system, previous treatment with an mTOR inhibitor. All patients had a Karnofsky performance status of at least 70 at the time of study entry
open-label
146 sites in 24 countries in North America, Europe, Australia, South America, and Asia;
P3 / two-sided test procedure with one interim analysis. Hierarchical statistical testing procedure (OS then PFS)
Among patients with previously treated advanced renal-cell carcinoma, overall survival was significantly longer and fewer grade 3 or 4 adverse events occurred with nivolumab than with everolimus.
atezolizumab plus bevacizumab (n=276) vs. sunitinib (n=277)
randomized controlled trial
atezolizumab plus bevacizumab
atezolizumab 1200 mg intravenously then bevacizumab 15 mg/kg intravenous infusions once every 3 weeks.
Sunitinib
sunitinib 50 mg once daily orally for 4 weeks, followed by 2 weeks of rest
No prespecified crossover was planned per protocol. Patients could continue atezolizumab plus bevacizumab or sunitinib
mRCC - L1 - PDL1 negative
Patients were excluded if they had received previous systemic treatment or if they had untreated brain metastases.
open label
152 sites across 21 countries
P3 / two-sided test procedure with two interim analysis. AI 1 (12 months) repartition between coprmary endpoints (0.04 PFS and 0.01 OS) and then hierarchy with OS (PDL1>1%)
Atezolizumab plus bevacizumab did not significantly prolonged progression-free survival versus sunitinib in patients with metastatic renal cell carcinoma but showed a favourable safety profile. exploratory results for this arm
atezolizumab alone (n=54) vs. sunitinib (n=60)
randomized controlled trial
atezolizumab
atezolizumab 1,200mg fixed intravenous dose every three weeks
sunitinib
sunitinib 50mg/d orally for four weeks followed by two weeks of rest
3 bras : atezolizumab, atezolizumab and bevacizumab, sunitinibpatients randomized to atezolizumab monotherapy or sunitinib had the option to cross over and receive the atezolizumab bevacizumab combination in some regions
mRCC - L1 - PDL1 positive
patietns had a Karnofsky performance score ≥ 70, . Patients were required to have adequate hematologic and end-organ function.
open-label
96 institution
P2/interim analysis planned but no treshhold, no stratistic plan found (no protocol)
Overall, data from IMmotion150 suggest (did not demonstrare PFS benefit) that atezolizumab plus bevacizumab may particularly enhance PFS benefit in patients with pre-existing antitumor immunity (as determined by a high Teff score and PD-L1 IC expression) compared with sunitinib
atezolizumab plus bevacizumab (n=50) vs. sunitinib (n=60)
randomized controlled trial
atezolizumab with bevacizumab
atezolizumab 1,200mg fixed intravenous dose bevacizumab 15mg/kg every three weeks
sunitinib
sunitinib 50mg/d orally for four weeks followed by two weeks of rest
3 bras : atezolizumab, atezolizumab and bevacizumab, sunitinibpatients randomized to atezolizumab monotherapy or sunitinib had the option to cross over and receive the atezolizumab bevacizumab combination in some regions
mRCC - L1 - PDL1 positive
they had a Karnofsky performance score ≥ 70, . Patients were required to have adequate hematologic and end-organ function.
open-label
96 institution
P2/interim analysis planned but no treshhold, no stratistic plan found (no protocol)
Overall, data from IMmotion150 suggest (did not demonstrare PFS benefit) that atezolizumab plus bevacizumab may particularly enhance PFS benefit in patients with pre-existing antitumor immunity (as determined by a high Teff score and PD-L1 IC expression) compared with sunitinib
atezolizumab plus bevacizumab (n=178) vs. sunitinib (n=184)
randomized controlled trial
atezolizumab plus bevacizumab
atezolizumab 1200 mg intravenously then bevacizumab 15 mg/kg intravenous infusions once every 3 weeks.
Sunitinib
sunitinib 50 mg once daily orally for 4 weeks, followed by 2 weeks of rest
No prespecified crossover was planned per protocol. Patients could continue atezolizumab plus bevacizumab or sunitinib
mRCC - L1 - PDL1 positive
Patients were excluded if they had received previous systemic treatment or if they had untreated brain metastases.
open label
152 sites across 21 countries
P3 / two-sided test procedure with two interim analysis. AI 1 (12 months) repartition between coprmary endpoints (0.04 PFS and 0.01 OS) and then hierarchy with OS (PDL1>1%)
Atezolizumab plus bevacizumab did not significantly prolonged progression-free survival versus sunitinib in patients with metastatic renal cell carcinoma but showed a favourable safety profile. exploratory results for this arm
avelumab plus axitinib (n=270) vs. sunitinib (n=290)
randomized controlled trial
Avelumab plus Axitinib
Avelumab was administered at a dose of 10 mg per kilogram of body weight as a 1-hour intravenous infusion every 2 weeks, Axitinib was administered orally at a starting dose of 5 mg twice daily on a continuous dosing schedule.An antihistamine and acetaminophen were administered approximately 30 to 60 minutes before each infusion.
Sunitinib
Sunitinib was administered at a dose of 50 mg orally once daily for 4 weeks of an 6-week cycle.
Dose reductions of avelumab were not permitted, but subsequent infusions could be omitted in response to persisting toxic effects. Dose escalations and reductions of axitinib and dose reductions of sunitinib are described in the protocol
mRCC - L1 - PDL1 positive
patients with IMDC and MSKCC prognostic risk groups were included.Key exclusioncriteria included active central nervous system metastases
open label
144 sites in 21 countries
P3 /one sided test procedure with one interim analysis . Repartition between coprimary endpoints (0.004/0.021) and hierarchical testing procedure with secondary endpoints
Progression-free survival was significantly longer with avelumab plus axitinib than withsunitinib among patients who received these agents as first-line treatment for advancedrenal-cell carcinoma (ITT and PDL1>1%)
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