NCT03737123

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

A Phase II Trial of Atezolizumab Plus Chemotherapy After Progression on PD-1 or PD-L1 Inhibitor in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma: HCRN GU17-295

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Nabil Adra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Carboplatin	Carboplatin AUC 4 IV Day 1 of each 21 day cycle
DRUG	Gemcitabine	Gemcitabine 1,000 mg/m2 IV Day 1 and Day 8 of each 21 day cycle
DRUG	Atezolizumab	Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle
DRUG	Docetaxel	Docetaxel 75 mg/m2 IV Day 1 of each 21 day Cycle.

Timeline

• Start date: 2018-12-19
• Primary completion: 2022-03-08
• Completion: 2022-05-18
• First posted: 2018-11-09
• Last updated: 2023-09-13
• Results posted: 2023-09-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study