Non-muscle Invasive Bladder CancerPhase 2ADVANCED-2NCT05951179
Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
A Phase 2 study testing TARA-002 in people with Non-muscle Invasive Bladder Cancer, run by Protara Therapeutics at 78 sites in 7 countries.
Trial summary
TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-muscle Invasive Bladder Cancer
- What is being tested?
- TARA-002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 78 sitesin 7 countries
- Study dates
- 15 Sep 2023to Mar 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 (Cohort A). Participants with CIS (± Ta/T1) who are BCG unresponsive.
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
78 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
78 sites in 7 countries
United States44 sites, 36 recruiting
- Withdrawn
Amarillo Urology Research
Amarillo, Texas, 79106
- Recruiting
Urology Partners of North Texas
Arlington, Texas, 76017
Use Central Contact
- Recruiting
Colorado University - Anshutz
Aurora, Colorado, 80045
Use Central Contact
- Recruiting
Urology Austin, LLC
Austin, Texas, 78745
Use Central Contact
- Recruiting
Michael Oefelein Clinical Trials
Bakersfield, California, 93301
Use Central Contact
- Recruiting
Minnesota Urology, Woodbury
Bloomington, Minnesota, 55425
Use Central Contact
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Use Central Contact
- Recruiting
Cleveland Clinic Main Campus, Cleveland
Cleveland, Ohio, 44195
Use Central Contact
- Recruiting
AdventHealth Medical Group Urology of Denver
Denver, Colorado, 80211
Use Central Contact
- Withdrawn
University of Florida Health Jacksonville
Gainesville, Florida, 32611
- Terminated
AccuMed Research Associates
Garden City, New York, 11530
- Recruiting
Urology Centers of Alabama
Homewood, Alabama, 35209
Use Central Contact
- Recruiting
Houston Metro Urology
Houston, Texas, 77027
Use Central Contact
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Use Central Contact
- Withdrawn
Clinical Trial Network
Houston, Texas, 77074
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Use Central Contact
- Recruiting
Southern Urology
Lafayette, Louisiana, 70508
Use Central Contact
- Recruiting
Comprehensive Urologic Care
Lake Barrington, Illinois, 60010
Use Central Contact
- Recruiting
Advanced Urology
Lakewood, Colorado, 80228
Use Central Contact
- Recruiting
Arkansas Urology
Little Rock, Arkansas, 72211
Use Central Contact
- Recruiting
Urology Associates of Denver
Lone Tree, Colorado, 80124
Use Central Contact
- Terminated
Urology Group of Southern California
Los Angeles, California, 90017
- Recruiting
Conrad Person Clinic
Memphis, Tennessee, 38128
Use Central Contact
- Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Use Central Contact
- Recruiting
Urology Associates PC
Nashville, Tennessee, 37209
Use Central Contact
- Recruiting
Laura & Isaac Perlmutter Cancer Center - NYU Langone Health
New York, New York, 10016
Use Central Contact
- Recruiting
University of California Irvine Medical Center
Orange, California, 92697
Use Central Contact
- Recruiting
Mayo Clinic
Phoenix, Arizona, 85054
Use Central Contact
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Use Central Contact
- Recruiting
Greater Boston Urology, LLC
Plymouth, Massachusetts, 02360
Use Central Contact
- Recruiting
East Valley Urology Center of Arizona
Queen Creek, Arizona, 85140
Use Central Contact
- Recruiting
Virginia Urology
Richmond, Virginia, 23235
Use Central Contact
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Use Central Contact
- Recruiting
University of Rochester, Department of Urology
Rochester, New York, 14642
Use Central Contact
- Recruiting
UT Health San Antonio
San Antonio, Texas, 78229
Use Central Contact
- Withdrawn
Genesis Research
San Diego, California, 92123
- Withdrawn
Ochsner Health LSU - Regional Urology
Shreveport, Louisiana, 71105
- Recruiting
Spokane Urology
Spokane, Washington, 99202
Use Central Contact
- Recruiting
Renown Regional Medical Center
St Louis, Missouri, 63110
Use Central Contact
- Recruiting
Specialty Clinic Research of St. Louis
St Louis, Missouri, 63141
Use Central Contact
- Recruiting
Associated Medical Professionals of NY, PLLC
Syracuse, New York, 13210
Use Central Contact
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Use Central Contact
- Withdrawn
University of Toledo
Toledo, Ohio, 43606
- Recruiting
Genesis Research LLC
Torrance, California, 90505
Use Central Contact
Japan12 sites, 12 recruiting
- Recruiting
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki-shi, Hyōgo, 660-8550
Use Central Contact
- Recruiting
Toho University Medical Center Sakura Hospital
Fuji-shi, Shizuoka, 417-8567
Use Central Contact
- Recruiting
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Use Central Contact
- Recruiting
Funabashi Municipal Medical Center
Funabashi-shi, Chiba, 273-8588
Use Central Contact
- Recruiting
Hitachi General Hospital
Hitachi-shi, Ibaraki, 317-0077
Use Central Contact
- Recruiting
Komaki City Hospital
Komaki-shi, Aichi-ken, 485-0044
Use Central Contact
- Recruiting
Japanese Red Cross Aichi Medical Center Nayoya Daiichi
Nagoya, Aichi-ken, 435-8511
Use Central Contact
- Recruiting
Niigata Cancer Center Hospital
Niigata, Niigata, 961-8566
Use Central Contact
- Recruiting
Japanese Red Cross Osaka Hospital
Osaka, Osaka, 543-855
Use Central Contact
- Recruiting
Fuji City General Hospital
Sakura-shi, Chiba, 285-8741
Use Central Contact
- Recruiting
Toyama University Hospital
Toyama, Toyama, 930-0152
Use Central Contact
- Recruiting
Yokohama Municipal Citizen's Hospital
Yokohama, Kanagawa, 221-0855
Use Central Contact
Brazil8 sites, 8 recruiting
- Recruiting
Hospital de Clinicas da UNICAMP
Campinas, São Paulo, 13083-970
Use Central Contact
- Recruiting
Instituto Dor de Pesquisa e Ensino
Jardim Paulista, São Paulo, 01401-002
Use Central Contact
- Recruiting
Kyushu University Hospital
Nova Lima, Minas Gerais, 34006-059
Use Central Contact
- Recruiting
Office of Lucas Nougeria MA
Nova Lima, Minas Gerais, 34006-059
Use Central Contact
- Recruiting
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-070
Use Central Contact
- Recruiting
Nucleo de Pesquisa Clinica do Rio Grande so Sul
Porto Alegre, Rio Grande do Sul, 90430-001
Use Central Contact
- Recruiting
Centro de Urologia Avancada
Porto Alegre, Rio Grande do Sul, 91350-200
Use Central Contact
- Recruiting
Faculdade de Medicina ABC-CEPHO
Santo André, São Paulo, 09060-650
Use Central Contact
Argentina7 sites, 7 recruiting
- Recruiting
Hospital Italiano de Buenos Aires (HIBA)
Buenos Aires, C1199ABB
Use Central Contact
- Recruiting
Hospital Britanico de Buenos Aires
Buenos Aires, C1280
Use Central Contact
- Recruiting
Centro Argentino de Urologia
CABA, C1419
Use Central Contact
- Recruiting
Hospital Sirio Libanes
CABA, C1419
Use Central Contact
- Recruiting
Centro Urologico Profesor Bengio SA
Córdoba, X5000KPH
Use Central Contact
- Recruiting
CEMAIC
Córdoba, X5088
Use Central Contact
- Recruiting
Clinica Privada Independencia
Munro, 1605
Use Central Contact
Canada5 sites, 2 recruiting
- Terminated
Exdeo Clinical Research Inc
Abbotsford British Columbia, British Columbia, V2T 1X8
- Withdrawn
Jonathan Giddes Medicine Professional Corporation
Brampton, Ontario, L6T 4S5
- Recruiting
The Research Institute of the McGill University Health Centre
Montreal, Quebec, H3H 2R9
Use Central Contact
- Withdrawn
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
- Recruiting
UHN Princess Margaret Cancer Centre Princess Margaret Hospital
Toronto, Ontario, M5G 1Z5
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Kanagawa, 807561
Use Central Contact
Ukraine1 site, 1 recruiting
- Recruiting
Arensia Kapitanivka - PPDS
Kapitanivka, 08111
Use Central Contact
About this study
Official title: A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer
TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1).
The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and efficacy of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a).
Read more
This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease, defined as disease present at last tumor evaluation (within 3 months) prior to signing the ICF.
Participants will be enrolled into one of 2 cohorts:
Cohort A:
- Participants with CIS (± Ta/T1) who are BCG naive, or
- Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis
Cohort B:
- Participants who are BCG unresponsive
- Conditions
- Non-muscle Invasive Bladder Cancer
- Being tested
- TARA-002
- Keywords
- Non-muscle invasive bladder Cancer, bladder cancer, high grade Ta, high grade NMIBC, carcinoma in situ
- Medical subject headings
- 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-002Biological
All participants will receive 6 weekly instillations of TARA-002 at the established RP2D (First Treatment Period). Participants who are eligible for reinduction after the First Treatment Period will receive 6 additional weekly doses of TARA-002 instillation as part of the Second Treatment Period. Participants confirmed to have a complete response after the First Treatment Period will receive 3 additional weekly doses of TARA-002 instillation as maintenance during the Second Treatment Period. All eligible participants will receive 3 weekly doses of TARA-002 instillation as part of the Third Treatment Period (maintenance) at Months 6, 9, 12, 15, 18 and 24. Following the Third Treatment Period, all participants will continue to the Follow up Period from Month 27 until Month 60.
| Study group | Role | What they receive |
|---|---|---|
| TARA-002 | Experimental | TARA-002 is a lyophilized biological preparation for instillation containing cells of Streptococcus pyogenes (Group A, type 3) Su strain. Receives: Biological: TARA-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort A and B: Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002
Measured: Month 3 to Month 60
Secondary outcomes (17)
Cohort A: Incidence of high-grade Complete Response at any time by subgroup (BCG naive and BCG exposed > 24 months) according to central pathology after treatment with TARA-002
Measured: Month 3 to Month 60
Cohort A and B: Duration of high-grade Complete Response rate at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002
Measured: Month 3 to Month 60
Cohort A and B: High-grade Complete Response rate at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002
Measured: Month 3 to Month 60
Cohort A and B: Duration of Complete Response (all recurrent bladder cancer, including low grade Ta) after treatment with TARA-002
Measured: Month 3 to Month 60
Cohort A and B: Complete Response rate (all recurrent bladder cancer, including low grade Ta) at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002
Measured: Month 3 to Month 60
Cohort A and B: Progression free survival after treatment with TARA-002
Measured: 60 months
Cohort A and B: Disease-specific progression free survival after treatment with TARA-002
Measured: 60 months
Cohort A and B: Overall survival after treatment with TARA-002
Measured: 60 months
Cohort A and B: Disease specific survival after treatment with TARA-002
Measured: 60 months
Cohort A and B: Time to cystectomy after treatment with TARA-002
Measured: 60 months
Cohort A and B: Time to recurrence delayed cystectomy after treatment with TARA-002
Measured: 60 months
Cohort A and B: Time to progression after treatment with TARA-002
Measured: 60 months
Cohort A and B: Time to disease worsening after treatment with TARA-002
Measured: 60 months
Cohort A and B: Incidence and severity of AEs, TEAEs, SAEs and TESAEs after treatment with TARA-002
AE = adverse event; TEAE = treatment emergent adverse event; SAE = serious adverse event; TESAE = treatment emergent serious adverse event
Measured: Day 1 to Month 60
Cohort A and B: Change from baseline in urine pharmacodynamic biomarker levels (including IL-6, IL-8, IFN-γ, and TNF-α) after treatment with TARA-002
Measured: Day 1 to Day 72
Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-NMIBC24
EORTC = European Organization for Research and Treatment of Cancer; QLQ-NMIBC24 = Questionnaire for Patients with NMIBC
Measured: Day 1 to Month 24
Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-C30
EORTC = European Organization for Research and Treatment of Cancer; QLQ-C30 = Questionnaire for Patients with Cancer
Measured: Day 1 to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start15 Sep 2023
- Primary completionOct 2031 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-muscle Invasive Bladder 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive 6 weekly instillations of TARA-002 at the established RP2D (First Treatment Period). Participants who are eligible for reinduction after the First Treatment Period will receive 6 additional weekly doses of TARA-002 instillation as part of the Second Treatment Period. Participants confirmed to have a complete response after the First Treatment Period will receive 3 additional weekly doses of TARA-002 instillation as maintenance during the Second Treatment Period. All eligible participants will receive 3 weekly doses of TARA-002 instillation as part of the Third Treatment Period (maintenance) at Months 6, 9, 12, 15,18, and 24. Following the Third Treatment Period, all participants will continue to the Follow up Period from Month 27 until Month 60.
- Masking
- None (open label)
- Enrolment
- 131 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Protara Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Scientific Operations Officer, Study director, Protara Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951179
- Sponsor's protocol ID
- TARA-002-101-Ph2
- Acronym
- ADVANCED-2
- Status last verified
- Jan 2026
- First submitted
- 29 Jun 2023
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT05951179
- Acronym / sponsor ID
- ADVANCED-2 / TARA-002-101-Ph2
- Conditions
- Non-muscle Invasive Bladder Cancer
- Keywords
- Non-muscle invasive bladder Cancer, bladder cancer, high grade Ta, high grade NMIBC, carcinoma in situ
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 131 participants (estimated)
- Lead sponsor
- Protara TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1).
The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and efficacy of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a).
This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease, defined as disease present at last tumor evaluation (within 3 months) prior to signing the ICF.
Participants will be enrolled into one of 2 cohorts:
Cohort A:
- Participants with CIS (± Ta/T1) who are BCG naive, or
- Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis
Cohort B:
- Participants who are BCG unresponsive
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive 6 weekly instillations of TARA-002 at the established RP2D (First Treatment Period). Participants who are eligible for reinduction after the First Treatment Period will receive 6 additional weekly doses of TARA-002 instillation as part of the Second Treatment Period. Participants confirmed to have a complete response after the First Treatment Period will receive 3 additional weekly doses of TARA-002 instillation as maintenance during the Second Treatment Period. All eligible participants will receive 3 weekly doses of TARA-002 instillation as part of the Third Treatment Period (maintenance) at Months 6, 9, 12, 15,18, and 24. Following the Third Treatment Period, all participants will continue to the Follow up Period from Month 27 until Month 60.
| Arm | Type | Receives |
|---|---|---|
| TARA-002 | Experimental | Biological: TARA-002TARA-002 is a lyophilized biological preparation for instillation containing cells of Streptococcus pyogenes (Group A, type 3) Su strain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (Cohort A). Participants with CIS (± Ta/T1) who are BCG unresponsive.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TARA-002All participants will receive 6 weekly instillations of TARA-002 at the established RP2D (First Treatment Period). Participants who are eligible for reinduction after the First Treatment Period will receive 6 additional weekly doses of TARA-002 instillation as part of the Second Treatment Period. Participants confirmed to have a complete response after the First Treatment Period will receive 3 additional weekly doses of TARA-002 instillation as maintenance during the Second Treatment Period. All eligible participants will receive 3 weekly doses of TARA-002 instillation as part of the Third Treatment Period (maintenance) at Months 6, 9, 12, 15, 18 and 24. Following the Third Treatment Period, all participants will continue to the Follow up Period from Month 27 until Month 60. | Biological | TARA-002 |
Primary outcome
Cohort A and B: Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002
Time frame: Month 3 to Month 60
17 secondary outcomes
Cohort A: Incidence of high-grade Complete Response at any time by subgroup (BCG naive and BCG exposed > 24 months) according to central pathology after treatment with TARA-002
Time frame: Month 3 to Month 60
Cohort A and B: Duration of high-grade Complete Response rate at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002
Time frame: Month 3 to Month 60
Cohort A and B: High-grade Complete Response rate at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002
Time frame: Month 3 to Month 60
Cohort A and B: Duration of Complete Response (all recurrent bladder cancer, including low grade Ta) after treatment with TARA-002
Time frame: Month 3 to Month 60
Cohort A and B: Complete Response rate (all recurrent bladder cancer, including low grade Ta) at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002
Time frame: Month 3 to Month 60
Cohort A and B: Progression free survival after treatment with TARA-002
Time frame: 60 months
Cohort A and B: Disease-specific progression free survival after treatment with TARA-002
Time frame: 60 months
Cohort A and B: Overall survival after treatment with TARA-002
Time frame: 60 months
Cohort A and B: Disease specific survival after treatment with TARA-002
Time frame: 60 months
Cohort A and B: Time to cystectomy after treatment with TARA-002
Time frame: 60 months
Cohort A and B: Time to recurrence delayed cystectomy after treatment with TARA-002
Time frame: 60 months
Cohort A and B: Time to progression after treatment with TARA-002
Time frame: 60 months
Cohort A and B: Time to disease worsening after treatment with TARA-002
Time frame: 60 months
Cohort A and B: Incidence and severity of AEs, TEAEs, SAEs and TESAEs after treatment with TARA-002
Time frame: Day 1 to Month 60
Cohort A and B: Change from baseline in urine pharmacodynamic biomarker levels (including IL-6, IL-8, IFN-γ, and TNF-α) after treatment with TARA-002
Time frame: Day 1 to Day 72
Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-NMIBC24
Time frame: Day 1 to Month 24
Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-C30
Time frame: Day 1 to Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chief Scientific Operations Officer study director
Protara Therapeutics
78 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TARA-002 in people with Non-muscle Invasive Bladder Cancer, run by Protara Therapeutics at 78 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in United States, Japan, Brazil, Argentina, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chief Scientific Operations Officer (16468440337, clinicaltrials@protaratx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort A and B: Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002 (time frame: Month 3 to Month 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.