drugset / Trial / NCT03737123

Trial of Atezolizumab Plus Chemotherapy After Progression on PD-1 or PD-L1 in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma

NCT03737123 ↗

NaSingle-groupOpen-labelTreatment

Summary

This is a single arm phase II study assessing the activity of atezolizumab in combination with carboplatin + gemcitabine or docetaxel compared to historical controls of chemotherapy only in metastatic or recurrent urothelial carcinoma subjects. Subjects that received a PD 1 or PD-L1 inhibitor with no prior platinum chemotherapy for metastatic disease will be treated with atezolizumab + carboplatin + gemcitabine on trial. Subjects that received sequential or concurrent PD1/PDL1 inhibitor and carboplatin-based regimen will be treated with atezolizumab + docetaxel on trial.

Timeline

Start
2018-12-19
Primary completion
2022-03-08
Completion
2022-05-18

Outcome

Outcome not reported

Stopped (Enrollment): “Lack of accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Carboplatin Small molecule — Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous

Indications