RecruitingPhase 2NCT05312671

Atezolizumab Plus Etoposide and Platinum in Small Cell Bladder Cancer

Atezolizumab With Platinum and Etoposide Chemotherapy Followed by Cystectomy for Patients With Localized Small Cell Neuroendocrine Bladder Cancer

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

63 participants

Start Date

Jun 27, 2022

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer Urothelial Carcinoma Bladder Small Cell Neuroendocrine Carcinoma of Bladder

Summary

This is a single arm, Phase II trial involving the use of atezolizumab plus platinum and etoposide for patients with locally advanced urothelial cancer. The primary goal of this trial is to assess the pathologic complete response rate at cystectomy in patients after being treated with a combination therapy of atezolizumab, platinum, and etoposide.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of atezolizumab (an immunotherapy drug) with etoposide and platinum-based chemotherapy for people with small cell bladder cancer — a rare and aggressive type of bladder cancer. The goal is to find a more effective treatment for this difficult-to-treat disease. **You may be eligible if...** - You have been confirmed by biopsy to have invasive bladder cancer with small cell or high-grade neuroendocrine features (with or without urothelial cancer) - Your cancer is localized (stage cT1–T4a, N1 or lower — has not spread widely) - You are medically fit enough to receive chemotherapy - Tumor tissue is available for testing **You may NOT be eligible if...** - Your cancer has spread beyond what the study defines as localized disease - You have serious heart, liver, kidney, or immune conditions that prevent treatment - You have previously received certain immunotherapy or chemotherapy regimens that conflict with study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab

Atezolizumab 20 mL (1200 mg) on Day 1, once every 3 weeks for up to 20 cycles (each cycle = 21 days)

DRUGCarboplatin

Carboplatin AUC 5 IV on Day 1, once every 3 weeks for first 4 cycles (each cycle = 21 days).

DRUGCisplatin

Cisplatin 70 mg/m2 IV on Day 1, once every 3 weeks for first 4 cycles (each cycle = 21 days).

DRUGEtoposide

Etoposide 100 mg/m2 IV on Days 1 - 3 every cycle for the first 4 cycles (each cycle = 21 days)

PROCEDURECystectomy

Cystectomy should be performed within 42 days after completion of last administered study therapy of induction phase (first 4 cycles of chemotherapy).