Study on Avelumab and Radiation for Muscle-Invasive Bladder Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03747419

Provider View

This clinical trial is exploring whether adding the immunotherapy drug Avelumab to standard radiation treatment can help treat muscle-invasive bladder cancer more effectively.

Patient Parameters

Program Overview

The purpose of this study is to see if combining Avelumab, an immunotherapy drug, with standard radiation treatment can better control muscle-invasive bladder cancer. Avelumab is designed to help the immune system fight cancer cells and is already approved for other types of cancer. This study will test its effectiveness when used with radiation for bladder cancer. Researchers will also look at participants' overall health and quality of life during and after treatment, and see if certain biological markers are linked to treatment outcomes.

Description

This is a Phase II clinical trial, which means it is testing the safety and effectiveness of a new treatment approach. The study is investigating whether Avelumab, an immunotherapy drug, can be safely combined with radiation therapy to treat muscle-invasive bladder cancer. While radiation is a standard treatment for this type of cancer, using Avelumab with radiation is still being studied. Avelumab has been approved for other cancers, such as advanced Merkel cell carcinoma and certain bladder cancers that have not responded to chemotherapy. The study aims to determine if this combination can improve treatment outcomes and will also assess participants' health and quality of life during the study. Researchers will also explore if specific biomarkers are associated with better treatment results.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with muscle-invasive bladder cancer within the last 6 months.
  • Unable to receive cisplatin-based chemotherapy due to specific health conditions or personal choice.
  • Aged 18 years or older.
  • In good general health with a performance status that allows for daily activities.
  • Life expectancy of more than one year.
  • Normal organ and bone marrow function.
  • Kidney function with creatinine clearance above 30 mL/min.
  • Women of childbearing age must have a negative pregnancy test.
  • Agree to use effective birth control during the study and for 30 days after the last dose of Avelumab.
  • Able to start treatment within 1-8 weeks after the most recent bladder surgery.
  • Willing to sign an informed consent form.

Exclusion Criteria

  • Previous intravenous therapy for bladder cancer.
  • Previous radiation treatment to the pelvic area.
  • Presence of small cell cancer in the bladder.
  • Currently receiving other cancer treatments.
  • Using immunosuppressive medications, except for certain low-dose steroids.
  • History of another cancer within the last 5 years, except for certain skin cancers or localized prostate cancer.
  • Evidence of cancer spread to lymph nodes or other organs.
  • Significant heart disease or recent heart attack or stroke.
  • Severe allergic reactions to similar drugs.
  • Breastfeeding women unwilling to stop during treatment.
  • Positive for HIV or AIDS.
  • Active autoimmune disease that could worsen with treatment.
  • Active infection requiring IV antibiotics.
  • Recent vaccination with live vaccines.
  • Major surgery within the last 30 days, except for bladder surgery.
  • Active hepatitis B or C infection.
  • Previous organ transplant.
  • Unwilling to stop using herbal remedies that affect the immune system.
  • Severe ongoing side effects from previous treatments.
  • Other serious medical or psychiatric conditions that could interfere with the study.
  • Pregnant women.

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