Study on Lurbinectedin With or Without Avelumab for Small Cell Bladder Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06228066

Provider View

This clinical trial is exploring whether the drugs Lurbinectedin and Avelumab, used separately or together, can help treat small cell carcinoma of the bladder (SCCB) and other similar aggressive cancers of the urinary tract.

Patient Parameters

Program Overview

Small cell carcinoma of the bladder (SCCB) and other high-grade neuroendocrine tumors (HGNET) of the urinary tract are rare but aggressive cancers. People diagnosed with these cancers typically have a survival rate of about 1 year. Lurbinectedin and Avelumab are drugs approved for other cancers, and researchers are testing if they can help people with SCCB or HGNET. The study aims to see how effective Lurbinectedin is, with or without Avelumab, in treating these cancers.

Description

Small cell carcinoma of the bladder (SCCB) is a rare and aggressive type of bladder cancer. High-grade neuroendocrine tumors (HGNET) of the urinary tract are also rare and include small cell and large cell neuroendocrine carcinomas. These cancers often respond well to initial chemotherapy but tend to return quickly. Lurbinectedin is a drug that targets cancer cell growth and has shown promise in treating small cell lung cancer. Avelumab is an immune therapy drug that helps the body's immune system fight cancer. This study is testing if these drugs can be effective for SCCB and HGNET.

The study is open to adults aged 18 and older with SCCB or HGNET that has returned and spread after treatment. Participants will receive Lurbinectedin, and those who haven't been treated with immune therapy drugs like Avelumab before may receive both drugs. Treatment is given every 3 weeks and can continue for up to 10 years if it helps. Participants will have regular check-ups, including blood tests, scans, and possibly biopsies, to monitor their health and the treatment's effects. If treatment stops, follow-up visits will occur 14, 30, and 90 days after the last dose, with additional visits over 5 to 10 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of metastatic small cell carcinoma of the bladder (SCCB) or other high-grade neuroendocrine tumors (HGNETs) of the urinary tract.
  • Cancer must have spread or shown new growth.
  • Must have at least one measurable tumor.
  • Must have received, be ineligible for, or refused prior chemotherapy with platinum/etoposide.
  • Must have good organ and bone marrow function, as shown by specific blood test results.
  • Women of childbearing potential must agree to use effective birth control during and after the study.
  • Men must agree to use effective birth control during and after the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Have received investigational drugs, chemotherapy, or immunotherapy within 14 days before starting the study.
  • Have been treated with Lurbinectedin before.
  • Have severe allergic reactions to similar drugs.
  • Have untreated or symptomatic brain metastases.
  • Have active autoimmune diseases that could worsen with Avelumab, except for certain conditions like controlled diabetes or thyroid disorders.
  • Are on high-dose steroids or other immunosuppressive drugs.
  • Have had an organ transplant.
  • Have received a live vaccine within 30 days before starting the study.
  • Are pregnant or have severe uncontrolled illnesses.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.