BCG Response Prediction for Bladder Cancer

Recruiting at 4 trial locations

Overseen By Charles Rosser, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Oral glucocorticoids

Disqualifiers: Tuberculosis, Radical cystectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a urine-based test to predict the response of bladder cancer patients to intravesical BCG treatment, a therapy delivered directly to the bladder. Currently, about half of the patients do not respond to BCG, necessitating additional treatments or surgery. The trial seeks participants with bladder cancer who have recently had visible tumors removed and are scheduled for BCG therapy soon. This trial could help personalize treatment plans, enhancing their effectiveness for individuals. As a Phase 2 trial, the research focuses on evaluating the test's effectiveness in an initial, smaller group, potentially offering participants a more tailored treatment approach.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be taking oral glucocorticoids or planning to receive other cancer therapies while participating.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that administering BCG directly into the bladder is generally safe, though it can cause some side effects. Common issues include bladder irritation, feeling unwell, and fever. While these effects are not unusual, serious problems are rare. Approximately 8% of patients may need to stop treatment due to side effects. Although reports of severe infections exist, they are uncommon. Overall, most people tolerate BCG well, but awareness of these possible side effects is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Intravesical BCG is unique because it uses a live, weakened strain of bacteria to stimulate the immune system to fight bladder cancer. Unlike standard treatments like surgery or chemotherapy, BCG works by directly triggering the body's own defenses right inside the bladder. Researchers are excited about this treatment because it targets cancer cells more precisely, potentially reducing side effects and enhancing the body's natural ability to prevent cancer recurrence.

What evidence suggests that intravesical BCG might be an effective treatment for predicting treatment response?

Research shows that intravesical BCG (Bacillus Calmette-Guerin) is important for treating bladder cancer that hasn't spread into the muscle. Studies have found that about 50-70% of high-risk patients may experience cancer recurrence within five years. Despite these challenges, BCG therapy often prevents the cancer from worsening. While it doesn't work for everyone, it remains a crucial option for effectively managing bladder cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Charles Rosser, MD

Principal Investigator

Nonagen Bioscience Corporation

Hideki Furuya, PhD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder diagnosed within 90 days prior to scheduled BCG

Patients must have had all grossly visible papillary tumors removed within 30 days prior to scheduled BCG or cystoscopy confirming no grossly visible papillary tumors within 30 days prior to scheduled BCG

Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of nodal involvement or metastatic disease (CT scan or MRI scan) within 90 days prior to scheduled BCG

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravesical BCG treatment

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intravesical BCG

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Nonagen Bioscience Corporation

Industry Sponsor

Trials

5

Recruited

2,300+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

University of Rochester

Collaborator

Trials

883

Recruited

555,000+

Kyoto University

Collaborator

Trials

38

Recruited

26,500+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.4604

Subsequent treatments and outcomes in bacillus Calmette- ... Overall, 11,116 pts (48%) received > = 7 BCG doses and 1,094 pts recurred with CIS within 12 months of last BCG dose. Among them, 486 pts (44.4 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8764004/

Intravesical Bacillus Calmette-Guerin (BCG) Therapy for ... Intravesical BCG therapy is an integral part of management of non-muscle invasive bladder cancers. Our aim is to analyze the non-muscle invasive bladder cancer ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2588931125000811

Oncological Outcomes in Bacillus Calmette-Guérin–naïve ... Despite the efficacy of BCG therapy, 50–70% of HR-NMIBC cases recur within 5 yr, and 20–40% progress to muscle-invasive bladder cancer following ...

4. frontiersin.org frontiersin.org/journals/urology/articles/10.3389/fruro.2024.1309532/full

Outcomes of intravesical Bacillus Calmette-Guerin in ... After a median follow-up time of 37 months, 55% developed recurrence (29% non-muscle invasive, 32% muscle-invasive disease, 8% distant ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2777975

High-Risk Non–Muscle-Invasive Bladder Cancer Treated ... A total of 392 patients (95%) received adequate induction BCG therapy, and 152 (37%) received adequate BCG therapy. For all patients with high- ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39539079/

Safety profiles of intravesical Bacillus Calmette-Guerin in ... A comprehensive evaluation of intravesical BCG, including the safety profile and adverse events (AEs), is essential.

7. fda.gov fda.gov/media/76396/download

BCG Live Package Insert BCG is capable of dissemination when administered by the intravesical route, and serious infections, including fatal infections, have been reported in patients.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2405579420300073

Intravesical Bacillus Calmette-Guérin (BCG) treatment's ... A total of five patients were found to have a severe BCG related complication, with fever, chills, and irritative urinary signs being the most frequent ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4630183/

Managing the adverse events of intravesical bacillus ... The incidence of bladder irritation, general malaise, and fever is very high, while severe complications remain rare. Approximately 8% of patients have to stop ...

10. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e16584

Treatment patterns with intravesical bacillus Calmette ... Intravesical BCG is the recommended first-line treatment for high-risk NMIBC patients, with a recommended minimum 1-year duration consisting of 6 doses of ...