What side effects are associated with this type of intervention?

Common treatments for bladder cancer, including mTOR pathway inhibitors like rapamycin, often have side effects such as mouth sores, infections, fatigue, and gastrointestinal issues. Chemotherapy can cause neutropenia, nausea, hair loss, and increased risk of infection. Radiation therapy may lead to skin irritation, bladder irritation, and fatigue. These treatments aim to manage cancer but come with a range of potential adverse effects that need to be monitored and managed by healthcare providers.

What prior FDA approvals exist?

FDA-approved treatments for bladder cancer include a variety of chemotherapeutic agents and immunotherapies. While specific mTOR inhibitors like eRapa (encapsulated rapamycin) are being studied, other treatments such as atezolizumab and pembrolizumab, which are immune checkpoint inhibitors, have been approved for advanced urothelial carcinoma. These drugs target the PD-1/PD-L1 pathway to enhance the body's immune response against cancer cells. Additionally, enfortumab vedotin, an antibody-drug conjugate, has been approved for patients who have previously received platinum-based chemotherapy and PD-1/PD-L1 inhibitors.

What other types of research exist?

Promising novel alternatives to eRapa for bladder cancer patients include immune checkpoint inhibitors such as pembrolizumab and atezolizumab, which have shown efficacy in advanced urothelial carcinoma. Additionally, antibody-drug conjugates like enfortumab vedotin and sacituzumab govitecan are emerging as effective treatments. These therapies target specific cancer pathways and have demonstrated significant clinical benefits in recent trials.

← Back to Search

eRapa for Bladder Cancer Prevention

Phase 2

Recruiting

Led By Robert S Svatek, MD, MSCI

Research Sponsored by Rapamycin Holdings, Inc. dba Emtora Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years or older

Patients must not be taking oral glucocorticoids at the time of registration

Must not have

Another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin)

Taking oral glucocorticoids at the time of registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Summary

This study is evaluating whether a drug which is used to prevent organ rejection in transplant patients may also help prevent cancer from returning.

Who is the study for?

This trial is for adults over 18 with non-muscle invasive bladder cancer diagnosed within the last 90 days. They must not be pregnant, nursing, or taking oral glucocorticoids and should agree to use contraception. Those with localized prostate cancer under surveillance may join, but those with muscle-invasive bladder cancer or other active cancers (except certain skin cancers) cannot.

What is being tested?

The study tests if eRapa can prevent bladder cancer from coming back compared to a placebo. Participants will take the treatment for one year in this phase II trial where neither they nor the doctors know who's getting eRapa or placebo. The trial also looks at how eRapa affects immunity, cognition, physical function, and quality of life.

What are the potential side effects?

While specific side effects are not listed here, rapamycin can typically cause mouth sores, diarrhea, nausea; affect blood counts and cholesterol levels; increase infection risk; and potentially impact kidney function among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I am not taking oral glucocorticoids.

Select...

I have never had BCG treatment directly into my bladder.

Select...

I do not have any ongoing, untreated infections.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any active cancer except for skin cancer.

Select...

I am currently taking oral glucocorticoids.

Select...

I am unable to understand and agree to the study's details on my own.

Select...

I have received BCG treatment directly into my bladder in the past.

Select...

My bladder cancer has grown into the muscle layer or beyond.

Select...

I have been treated with Rapamycin before.

Select...

I am 17 years old or younger.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Cognitive Function

Change in Handgrip Strength

Change in Short Physical Performance Battery

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active Study Drug GroupActive Control1 Intervention

Patients will be given 0.5mg eRapa (encapuslated rapamycin) orally each weekday (Monday-Friday) for one year.

Group II: Placebo GroupPlacebo Group1 Intervention

Patients will be given a placebo (visually identical to the eRapa (encapsulated rapamycin)) orally each weekday (Monday-Friday) for one year.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bladder cancer treatments often target specific pathways to inhibit tumor growth and progression. One such pathway is the mTOR (mechanistic target of rapamycin) pathway, which is crucial for cell growth, proliferation, and survival. Inhibitors like rapamycin (and its encapsulated form, eRapa) work by blocking this pathway, thereby slowing down or stopping cancer cell growth. This is particularly important for bladder cancer patients as it offers a targeted approach to treatment, potentially reducing tumor size and preventing relapse. Other common treatments include chemotherapy, which uses drugs to kill rapidly dividing cells, and immunotherapy, which boosts the body's immune system to fight cancer cells. Understanding these mechanisms helps patients and doctors make informed decisions about the most effective treatment strategies.

New treatments for bladder cancer: when will we make progress?