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

NCT03737123 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-09-13

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Indiana University School of Medicine

    collaborator OTHER

  • Nabil Adra

    lead OTHER

Principal Investigators

  • Nabil Adra, MD · Indiana University Melvin and Bren Simon Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2022-03-08
Completion
2022-05-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03737123 on ClinicalTrials.gov