Study on Atezolizumab with Etoposide and Platinum for Small Cell Bladder Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05312671

Provider View

This clinical trial is testing a combination of the immunotherapy drug atezolizumab with chemotherapy drugs platinum and etoposide to see if it can help control small cell bladder cancer before surgery.

Patient Parameters

Program Overview

The purpose of this study is to find out if using atezolizumab together with chemotherapy drugs platinum and etoposide can effectively treat small cell bladder cancer that is locally advanced. The main goal is to see how well this combination works in eliminating cancer before surgery.

Description

This study involves patients aged 18 and older who have a specific type of bladder cancer called small cell or neuroendocrine carcinoma. Participants will receive a combination of the immunotherapy drug atezolizumab and chemotherapy drugs platinum and etoposide. The treatment is given in cycles every 21 days, and patients will undergo surgery to remove the cancer after completing the treatment cycles. After surgery, patients may continue receiving atezolizumab to help prevent the cancer from returning, for up to one year or until it is no longer beneficial. The study aims to determine if this combination treatment can improve outcomes for patients with this type of bladder cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with invasive bladder cancer with small cell or neuroendocrine features, with or without urothelial cancer.
  • Medically fit to receive chemotherapy, immunotherapy, and surgery.
  • Aged 18 years or older.
  • Good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Adequate blood cell counts and organ function as determined by specific blood tests.
  • Negative tests for HIV, hepatitis B, and hepatitis C, or these conditions are well-controlled.
  • Women of childbearing potential must agree to use effective contraception during and after treatment.
  • Men must agree to use contraception and refrain from donating sperm during and after treatment.
  • Willing to provide informed consent and comply with study requirements.

Exclusion Criteria

  • Have received prior treatment for small cell bladder cancer.
  • Have another active cancer, except for certain non-threatening types.
  • Have cancer that has spread to the brain or other parts of the body.
  • Have uncontrolled pain or high calcium levels related to the tumor.
  • Have a history of autoimmune diseases or immune deficiencies, with some exceptions.
  • Have significant lung or heart diseases.
  • Have had major surgery or severe infections recently.
  • Are pregnant or breastfeeding, or plan to become pregnant during or shortly after the study.
  • Have received certain vaccines or treatments recently that may interfere with the study.
  • Have allergies to any of the study drugs or their components.

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