Bladder (Urothelial, Transitional Cell) Cancer, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ, Non-Muscle Invasive Bladder Carcinoma
Conditions
Keywords
BCG-naive, Non-muscle invasive bladder Cancer, bladder cancer, carcinoma in situ
Brief summary
The goal of this clinical trial is to learn if TARA-002 can treat high-grade non-muscle invasive bladder cancer (NMIBC) in BCG-naïve adults 18 years of age or older. The main questions it aims to answer are: * Can the study drug help participants with this type of cancer? * Is the study drug safe? * What are the side effects of the study drug? Researchers will compare TARA-002 to chemotherapy to see if TARA-002 works to treat NMIBC.
Interventions
DRUGTARA-002
Participants will receive 6 weekly instillations of TARA-002. Participants confirmed to have a CR at Week 12 will enter the maintenance treatment period and will receive 3 additional weekly instillations of TARA-002 every 3 months up to Month 19, and then 3 weekly doses at Month 25. Participants who are eligible for reinduction at Week 12 will receive 6 additional weekly instillations of TARA-002. Participants who undergo reinduction and are confirmed to have a CR at Week 24 will enter the maintenance regimen treatment period and will receive 3 weekly instillations of TARA-002 every 3 months up to Month 19, and then 3 weekly doses at Month 25.
DRUGInvestigator's Choice of Intravesical Chemotherapy
Participants will receive 6 weekly instillations of Investigator's choice of intravesical chemotherapy. Participants confirmed to have a CR at Week 12 will enter the maintenance regimen treatment period and will receive one intravesical instillation of Investigator's choice of intravesical chemotherapy every 1 month up to Month 25.
Sponsors
Protara Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants receiving Investigator's choice of intravesical chemotherapy who are treatment failures and have CIS (±Ta) at any response assessment are eligible for crossover to TARA-002, provided they still meet all other study-specified eligibility requirements.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female participants 18 years of age or older at the time of signing informed consent * Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry * Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease * Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis, or participants who received ≤2 doses of BCG within the 24 months prior to the most recent CIS diagnosis
Exclusion criteria
* Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory * Central confirmed variant histology * Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment * Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past) * Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history For more information on eligibility criteria, please contact the Sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of high-grade complete response | Month 6 | Incidence of high-grade complete response of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy determined by cystoscopy, urine cytology, and bladder biopsy (if applicable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of high-grade complete response | Up to Month 60 | Duration of high-grade complete response of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
| Treatment emergent adverse events | Up to Month 60 | Incidence and severity of treatment emergent adverse events (TEAEs) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
| Treatment emergent serious adverse events | Up to Month 60 | Incidence and severity of treatment emergent serious adverse events (TESAEs) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
| High-grade complete response rate | At Months 3, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 | High-grade complete response rate of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy determined by cystoscopy, urine cytology, and bladder biopsy (if applicable) |
| High-grade complete response rate (CIS only) | Month 6 | High-grade complete response rate of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy determined by cystoscopy, urine cytology, and bladder biopsy (if applicable) in sub-group of participants with CIS only |
| Event-free survival | Up to Month 60 | Event-free survival (EFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
| Recurrence-free survival | Up to Month 60 | Recurrence-free survival (RFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
| Progression-free survival | Up to Month 60 | Progression-free survival (PFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
| Disease-specific progression-free survival | Up ro Month 60 | Disease-specific progression-free survival (DSPFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
| Overall survival | Up to Month 60 | Overall survival (OS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
| Disease-specific survival | Up to Month 60 | Disease-specific survival (DSS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
| Time to cystectomy | Up to Month 60 | Time to cystectomy of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
| Time to recurrence delayed cystectomy | Up to Month 60 | Time to recurrence delayed cystectomy of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
| Time to progression | Up to Month 60 | Time to progression of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
| Time to disease worsening | Up to Month 60 | Time to disease worsening of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
Countries
Ukraine, United States
Contacts
CONTACTChief R&D Officer
Outcome results
None listed