CheckMate-214, 2017 trial summary

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

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NCT02231749    N Engl J Med 2018;378:1277-1290  



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



EndpointX1N1X0N0TE95% CI PFS - -9 - -9 0,82[0,64; 1,05] ORR - -9 - -9 no data OS - -9 - -9 0,68[0,49; 0,95]0,22,01,0

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

press release

ASCO post

abstract ASCO

ESMO

press release

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news

ESMO

ClinicalTrial.gov record NCT02231749



Registering number NCT02231749 (see trial on clinicaltrials.gov)
Code Name