Bladder (Urothelial, Transitional Cell) CancerPhase 3ADVANCED-3NCT07480356
Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer
A Phase 3 study testing TARA-002 and Investigator's Choice of Intravesical Chemotherapy in people with Bladder (Urothelial, Transitional Cell) Cancer and Non-Muscle Invasive Bladder Carcinoma, run by Protara Therapeutics at 11 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer, Non-Muscle Invasive Bladder Carcinoma, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
- What is being tested?
- TARA-002 and Investigator's Choice of Intravesical Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 29 May 2026to Nov 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
United States9 sites, 9 recruiting
- Recruiting
Urology Partners of North Texas
Arlington, Texas, 76017
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- Recruiting
Urology of Greater Atlanta - Sandy Springs
Atlanta, Georgia, 30319
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- Recruiting
Urology Austin, LLC
Austin, Texas, 78745
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- Recruiting
Michael Oefelein Clinical Trials
Bakersfield, California, 93301
- Recruiting
Houston Metro Urology
Houston, Texas, 77027
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- Recruiting
Arkansas Urology
Little Rock, Arkansas, 72211
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- Recruiting
START - Carolinas
Myrtle Beach, South Carolina, 29572
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- Recruiting
East Valley Urology Center of Arizona
Queen Creek, Arizona, 85140
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- Recruiting
Renown Regional Medical Center
St Louis, Missouri, 63110
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Ukraine2 sites, 2 recruiting
- Recruiting
Arenia - Ivano-Frankivsk
Ivano-Frankivsk, 76018
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- Recruiting
Arensia Kapitanivka - PPDS
Kapitanivka, 08111
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About this study
Official title: A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-Grade Non-Muscle Invasive Bladder Cancer
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.
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Non-Muscle Invasive Bladder Carcinoma, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
- Being tested
- TARA-002, Investigator's Choice of Intravesical Chemotherapy
- Keywords
- BCG-naive, Non-muscle invasive bladder Cancer, bladder cancer, carcinoma in situ
- Medical subject headings
- Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms, Carcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TARA-002Drug
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.
Investigator's Choice of Intravesical ChemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| TARA-002 (Arm A) | Experimental | Not described Receives: Drug: TARA-002 |
| Investigator's choice of intravesical chemotherapy | Active comparator | Not described Receives: Drug: Investigator's Choice of Intravesical Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Month 6
Secondary outcomes (15)
Duration of high-grade complete response
Duration of high-grade complete response of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy
Measured: Up to Month 60
Treatment emergent adverse events
Incidence and severity of treatment emergent adverse events (TEAEs) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy
Measured: 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
Measured: 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)
Measured: 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
Measured: Month 6
Event-free survival
Event-free survival (EFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy
Measured: Up to Month 60
Recurrence-free survival
Recurrence-free survival (RFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy
Measured: Up to Month 60
Progression-free survival
Progression-free survival (PFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy
Measured: 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
Measured: Up ro Month 60
Overall survival
Overall survival (OS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy
Measured: Up to Month 60
Disease-specific survival
Disease-specific survival (DSS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy
Measured: Up to Month 60
Time to cystectomy
Time to cystectomy of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy
Measured: 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
Measured: Up to Month 60
Time to progression
Time to progression of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy
Measured: Up to Month 60
Time to disease worsening
Time to disease worsening of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy
Measured: Up to Month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start29 May 2026
- Primary completionApr 2028 (estimated)
- Study completionNov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder (Urothelial, Transitional Cell) CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Protara Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480356
- Sponsor's protocol ID
- TARA-002-301
- Acronym
- ADVANCED-3
- Status last verified
- Jun 2026
- First submitted
- 13 Mar 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No