Study on Copanlisib and Avelumab as Maintenance Therapy for Advanced Bladder Cancer

Sponsor: VA Office of Research and Development

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05687721

Provider View

This clinical trial is exploring a new treatment approach for patients with advanced bladder cancer who have responded well to initial chemotherapy. The study involves using a combination of a standard immunotherapy drug, avelumab, and a study drug, copanlisib, to maintain cancer control.

Patient Parameters

Program Overview

The study aims to find out if combining the immunotherapy drug avelumab with a study drug called copanlisib can help keep advanced bladder cancer under control after initial chemotherapy. Patients who have not shown cancer progression after chemotherapy may be eligible to participate. The treatment involves receiving both drugs through an IV, with avelumab given every two weeks and copanlisib given on specific days of a four-week cycle. Participants will be monitored for any changes in their cancer status.

Description

In this study, patients with advanced bladder cancer who have completed chemotherapy will be evaluated to see if their cancer has not progressed. If eligible, they will receive a combination of avelumab, a standard immunotherapy, and copanlisib, a study drug. Both drugs are given through an IV. Avelumab is administered every two weeks, while copanlisib is given on days 1, 8, and 15 of a four-week cycle. The study will monitor patients for any changes in their cancer and overall health.

Eligibility Criteria

Inclusion Criteria

  • Must be male or female, aged 18 or older.
  • Have a confirmed diagnosis of advanced bladder cancer.
  • Completed initial chemotherapy 4 to 10 weeks ago without cancer progression.
  • Eligible to receive avelumab as maintenance therapy.
  • Recent imaging tests completed within 28 days before starting the study.
  • Provide a tumor sample from a recent biopsy or surgery.
  • Have a life expectancy of at least 3 months.
  • Be in relatively good health with a performance status score of 2 or better.
  • Have adequate blood cell counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Men must agree to use effective contraception.
  • Willing to sign informed consent and comply with study requirements.
  • Have controlled diabetes and blood pressure.

Exclusion Criteria

  • Cancer progression after initial chemotherapy.
  • Recent major surgery or radiation therapy.
  • Participation in another investigational study within the last 4 weeks.
  • Previous treatment with certain cancer drugs.
  • Active brain metastases requiring steroids.
  • Other recent cancers, except for certain skin cancers or early-stage cancers.
  • Active autoimmune diseases requiring treatment.
  • Severe allergies to study drugs.
  • Uncontrolled diabetes or high blood pressure.
  • Active infections or recent vaccinations.
  • Pregnant or breastfeeding women, or those not using effective contraception.
  • History of noncompliance with medical treatments.
  • Unable to comply with study procedures.

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