A randomised clinical trial investigating the effect of nivolumab + ipilimumab versus sunitinib in intermediate and poor-risk patients previously untreated advanced or metastatic renal cell carcinoma
Studied treatment | nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by Opdivo 3 mg/kg every 2 weeks |
Control treatment | sunitinib 50 mg once daily for 4 weeks, followed by 2 weeks off before continuation of treatment |
Patients | intermediate and poor-risk patients previously untreated advanced or metastatic renal cell carcinoma |
Group sizes | -9 / -9 |
Blindness | open-label | Inclusion period | |
Follow-up duration | Centers | ||
Lost to FU | geographical localisation | ||
Primary endpoint | ORR, PFS, OS | Design | Parallel groups |
phase 3
Motzer RJ, Tannir NM, McDermott DF, Arén Frontera O, Melichar B, Choueiri TK, Plimack ER, Barthélémy P, Porta C, George S, Powles T, Donskov F, Neiman V, Kollmannsberger CK, Salman P, Gurney H, Hawkins R, Ravaud A, Grimm MO, Bracarda S, Barrios CH, Tomita Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med 2018;378:1277-1290 [PMID: 29562145] link to pdf add to Mendeley
Links
ClinicalTrial.gov record NCT02231749
All trials of nivolumab + ipilimumab
Appears in following systematic reviews: