IMvigor211 (IC2/3), trial summary    PDF trial summary

A randomised clinical trial investigating the effect of atezolizumab versus chemotherapy in patients with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen

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NCT02302807    



Studied treatment atezolizumab
Control treatment chemotherapy



Patients patients with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen
Group sizes467 / 464

IC2/3 patients as planned as step 1 of the hierarchical testing



Blindness open label Inclusion period
Follow-up duration Centers
Lost to FU geographical localisation global
Primary endpoint overall survival Design Parallel groups
HypotheseSuperiority

sequential testing of IC2/3 population in first then IC1/2/3 population; and finaly all-comers population



EndpointX1N1X0N0TE95% CI OS - 118 - 116 0,87[0,63; 1,21] PFS - 118 - 116 no data ORR - 118 - 116 no data CR - 118 - 116 no data0,22,01,0

the trial failed to shown any statitically significant results on any of the 3 planned comparisons. This trial is completly negative and failed to show that atezolizumab increases overall survival

Links

Press release

ClinicalTrial.gov record NCT02302807



Registering number NCT02302807 (see trial on clinicaltrials.gov)
Code Name

Comment: The sponsor has revealed that its phase III IMVigor 211 failed to meet the primary endpoint of extending overall survival compared with chemotherapy,