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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:
Researchers will compare TARA-002 to chemotherapy to see if TARA-002 works to treat NMIBC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TARA-002 (Arm A) | Experimental |
| |
| Investigator's choice of intravesical chemotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TARA-002 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of high-grade complete response | 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) | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of high-grade complete response | Duration of high-grade complete response of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy | Up to Month 60 |
| Treatment emergent adverse events |
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Inclusion Criteria:
Exclusion Criteria:
For more information on eligibility criteria, please contact the Sponsor.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chief R&D Officer | Contact | 16468440337 | clinicaltrials@protaratx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Valley Urology Center of Arizona | Recruiting | Queen Creek | Arizona | 85140 | United States |
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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.
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|
| Investigator's Choice of Intravesical Chemotherapy | Drug | 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. |
|
Incidence and severity of treatment emergent adverse events (TEAEs) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy
| Up to Month 60 |
| Treatment emergent serious adverse events | Incidence and severity of treatment emergent serious adverse events (TESAEs) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy | Up to Month 60 |
| High-grade complete response rate | 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) | At Months 3, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 |
| High-grade complete response rate (CIS only) | 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 | Month 6 |
| Event-free survival | Event-free survival (EFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy | Up to Month 60 |
| Recurrence-free survival | Recurrence-free survival (RFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy | Up to Month 60 |
| Progression-free survival | Progression-free survival (PFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy | Up to Month 60 |
| Disease-specific progression-free survival | Disease-specific progression-free survival (DSPFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy | Up ro Month 60 |
| Overall survival | Overall survival (OS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy | Up to Month 60 |
| Disease-specific survival | Disease-specific survival (DSS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy | Up to Month 60 |
| Time to cystectomy | Time to cystectomy of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy | Up to Month 60 |
| Time to recurrence delayed cystectomy | Time to recurrence delayed cystectomy of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy | Up to Month 60 |
| Time to progression | Time to progression of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy | Up to Month 60 |
| Time to disease worsening | Time to disease worsening of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy | Up to Month 60 |
| Arkansas Urology | Recruiting | Little Rock | Arkansas | 72211 | United States |
|
| Michael Oefelein Clinical Trials | Recruiting | Bakersfield | California | 93301 | United States |
| Renown Regional Medical Center | Recruiting | St Louis | Missouri | 63110 | United States |
|
| START - Carolinas | Recruiting | Myrtle Beach | South Carolina | 29572 | United States |
|
| Arensia Kapitanivka - PPDS | Recruiting | Kapitanivka | 08111 | Ukraine |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D002278 | Carcinoma in Situ |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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