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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Nabil Adra
Study ID
NCT03737123
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 19, 2018
Status verified
Aug 2023
Primary completion
Mar 8, 2022
Completion
May 18, 2022

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chemotherapy and Atezolizumab
    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.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From C1D1 until progression or death or up to a maximum of 26 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Indiana University Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Nebraska Methodist HosptialOmahaNebraska68114-
University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87102-
University of Cincinnati Cancer InstituteCincinnatiOhio45267-

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