IMVIGOR-130 (monotherapy), 0 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of atezolizumab versus control in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma

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NCT02807636    
1st line



Studied treatment Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
Control treatment Placebo+Gemcitabine+Carboplatin/Cisplatin

3rd arm with Atezolizumab Monotherapy



Patients Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
Group sizes-9 / -9



Blindness open-design Inclusion period
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint Design



EndpointX1N1X0N0TE95% CI OS - -9 - -9 no data CR - -9 - -9 no data PFS - -9 - -9 no data ORR - -9 - -9 no data grade 3-4 treatment-related adverse events - -9 - -9 no data0,22,01,0

the Data Monitoring Committees’ (DMC) early reviews found patients in the monotherapy arms with PD-L1 low status had decreased survival compared to patients who received cisplatin- or carboplatin-based chemotherapy

Links

FDA alert

ClinicalTrial.gov record NCT02807636



Registering number NCT02807636 (see trial on clinicaltrials.gov)
Code Name

Comment: the Data Monitoring Committees’ (DMC) early reviews found patients in the monotherapy arms with PD-L1 low status had decreased survival compared to patients who received cisplatin- or carboplatin-based chemotherapy