Ongoing Clinical Trials for Bladder Cancer Stage I With Cancer In Situ
There is currently 1 ongoing clinical trial for bladder cancer stage I with cancer in situ. This trial is investigating TARA-002, an immunotherapy treatment administered directly into the bladder, for patients with high-grade non-muscle invasive disease. The study is taking place in multiple countries including Romania and Spain.
Clinical trial locations
- Romania
- Spain
Study on the Safety and Effectiveness of TARA-002 for Adults with High-Grade Non-Muscle Invasive Bladder Cancer
This clinical trial is studying TARA-002, a new treatment made from inactivated bacteria called Streptococcus pyogenes. The treatment is placed directly into the bladder through a procedure called intravesical instillation. The study aims to find out how safe this treatment is and how well it works against high-grade non-muscle invasive bladder cancer.
Main inclusion criteria:
- Patients must be at least 18 years old, male or female
- Must have confirmed diagnosis of high-grade non-muscle invasive bladder cancer with active disease present
- For one group of participants: cancer cannot be treated with BCG therapy, or no BCG received for 24 months before diagnosis
- For another group: cancer did not respond to BCG treatment within 12 months after completing therapy
- Must not have received other investigational treatments for at least 6 weeks before joining the study
- Must be able to perform daily activities reasonably well (ECOG status 0, 1, or 2)
- Both male and female participants must use reliable birth control during the study and for 4 weeks after treatment ends
- Female participants of childbearing age must have a negative pregnancy test
- Unvaccinated patients must test negative for COVID-19 before starting treatment
Main exclusion criteria:
- Patients whose cancer has spread into the muscle layer of the bladder
- Patients outside the specified age range for the study
- Those unable to undergo necessary procedures like cystoscopy, bladder biopsy, or urine cytology testing
- Members of vulnerable populations requiring special protection
Focus and goal of the trial:
The study evaluates both the safety and effectiveness of TARA-002 in treating this type of bladder cancer. Participants receive the medication directly into their bladder and are carefully monitored through regular medical evaluations. The trial includes cystoscopy procedures that allow doctors to examine the inside of the bladder, bladder biopsies to collect tissue samples for testing, and urine tests to track how the treatment is working.
The study follows a structured timeline starting with an initial treatment phase where TARA-002 is administered according to a specific schedule. During the treatment administration phase, patients receive multiple doses while undergoing regular monitoring. Throughout the monitoring and evaluation phase, doctors track the treatment’s impact on the cancer and watch for any side effects. The study measures complete response rates at various time points and assesses how long any positive responses last. A follow-up phase continues after treatment ends to check for long-term effects, cancer recurrence, and changes in quality of life.
Investigational drug:
TARA-002 is an immunotherapy medication prepared from lyophilized powder for injection. It works by stimulating the immune system to attack cancer cells in the bladder. The treatment is administered directly into the bladder through intravesical instillation, allowing the medication to come into direct contact with cancer cells in the bladder lining. As an immunotherapy agent, TARA-002 aims to enhance the body’s natural defenses against cancer rather than directly attacking cancer cells like traditional chemotherapy.
Summary
Currently, there is one active clinical trial available for patients with bladder cancer stage I with cancer in situ. This trial is being conducted in Romania and Spain, making it accessible to patients in these European countries. The study focuses exclusively on TARA-002, representing a novel immunotherapy approach for patients whose cancer has not responded to or cannot be treated with standard BCG therapy. The trial design includes two distinct patient groups: those who are BCG-unresponsive or BCG-ineligible, reflecting the real-world challenge of treating high-grade non-muscle invasive bladder cancer when first-line therapy fails or is not an option. The study emphasizes comprehensive monitoring through regular bladder examinations and laboratory tests to ensure patient safety while evaluating treatment effectiveness.