Study on Encapsulated Rapamycin (eRapa) for Preventing Bladder Cancer Recurrence

Sponsor: Rapamycin Holdings, Inc. dba Emtora Biosciences

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04375813

Provider View

This clinical trial is testing whether a drug called encapsulated rapamycin (eRapa) can help prevent bladder cancer from coming back in patients with non-muscle invasive bladder cancer. The study will compare eRapa to a placebo over one year to see if it reduces cancer relapse and improves immune function, cognition, and physical health without affecting quality of life.

Patient Parameters

Program Overview

The purpose of this study is to find out if taking encapsulated rapamycin (eRapa) can help prevent bladder cancer from returning in patients who have non-muscle invasive bladder cancer (NMIBC). The study will last for one year and will compare eRapa to a placebo (a pill with no active drug) to see if it can lower the risk of cancer coming back. Researchers will also look at whether eRapa can improve immune system function, mental abilities, and physical health without negatively impacting how patients feel about their quality of life.

Description

This study is a phase II trial, meaning it is testing the effectiveness and safety of eRapa in a larger group of patients. Participants will be randomly assigned to receive either a low dose of eRapa or a placebo, taken Monday through Friday for one year, or until their cancer returns. Patients will have regular check-ups, including bladder exams every three months for the first two years, then every six months for the next two years, and once in the fifth year. Some patients may also receive standard BCG immune therapy alongside the study treatment. Throughout the study, participants will complete surveys about their health and quality of life, and undergo tests to check their cognitive and physical abilities. Blood samples will be collected regularly to monitor safety, immune response, and rapamycin levels. Participants will be followed for up to five years after joining the study.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with non-muscle invasive bladder cancer within the last 90 days.
  • Able to understand and agree to participate in the study.
  • 18 years or older.
  • Not taking oral glucocorticoids (a type of steroid medication).
  • No active, uncontrolled infections.
  • No other active cancers, except for certain skin cancers or early-stage cancers that are in remission.
  • Patients with localized prostate cancer under active surveillance are eligible.
  • Not pregnant or nursing, and willing to use effective birth control during the study.
  • All visible bladder tumors must have been removed within the last 90 days, or a recent exam must show no visible tumors.
  • For patients with T1 disease, recent imaging must show no spread to lymph nodes or other areas, and a re-exam must confirm the cancer is not more advanced than T1.
  • No previous treatment with intravesical BCG.

Exclusion Criteria

  • Have muscle-invasive bladder cancer (stage T2 or higher).
  • Unable to understand or agree to participate in the study.
  • Under 18 years old.
  • Currently taking oral glucocorticoids.
  • Have another cancer that requires active treatment, except for certain skin cancers.
  • At risk of pregnancy and not willing or able to use effective birth control during the study, or currently nursing.
  • Recent imaging shows cancer has spread to lymph nodes or other areas.
  • Previous treatment with intravesical BCG.
  • Previous treatment with Rapamycin.

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