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%)
JAVELIN Renal 101( PDL1>1%), 2019 NCT02684006
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%)