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Cancer Vaccine

TARA-002 for Bladder Cancer (ADVANCED-2 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Protara Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease

Male or female subjects 18 years of age or older at the time of signing the informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 3 to month 24

Awards & highlights

ADVANCED-2 Trial Summary

This trial is researching a new treatment for adults with high-grade bladder cancer. It will examine the safety and effectiveness of intravesical treatment with TARA-002.

Who is the study for?

Adults over 18 with high-grade non-muscle invasive bladder cancer who can't get BCG therapy or haven't had it in the last 24 months, or those not responding to BCG after adequate treatment. Excluded are those with certain types of bladder cancer, a history of more advanced cancer, penicillin allergy, and nodal/metastatic disease.Check my eligibility

What is being tested?

The study tests TARA-002's safety and effectiveness against bladder cancer when put directly into the bladder. It's for patients who've either never had BCG therapy or didn't respond well to it. The trial has two groups based on their previous response to BCG.See study design

What are the potential side effects?

While specific side effects aren't listed here, intravesical treatments like TARA-002 may cause discomfort during administration, urinary symptoms such as frequency and urgency, possible allergic reactions in case of sensitivities to components.

ADVANCED-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My bladder cancer is confirmed to be high-grade but not muscle-invasive.

Select...

I am 18 years or older and can give informed consent.

ADVANCED-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 3 to month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 3 to month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3 to month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cohort A: Incidence of high-grade Complete Response at any time after treatment with TARA-002

Cohort A: Incidence of high-grade Complete Response at any time by subgroup (BCG naive and BCG exposed > 24 months) after treatment with TARA-002

Cohort B: Incidence of high-grade Complete Response at any time after treatment with TARA-002

Secondary outcome measures

Cohort A: Change from baseline in inflammatory urine cytokines levels (including IL-6, IL-8, IFN-γ, and TNF-α) after treatment with TARA-002

Cohort A: Incidence and severity of AEs, TEAEs, SAEs and TESAEs after treatment with TARA-002

Cohort A: Quality of Life based on the EORTC questionnaire QLQ-C30

+17 more

ADVANCED-2 Trial Design

1Treatment groups

Experimental Treatment

Group I: TARA-002Experimental Treatment1 Intervention

TARA-002 is a lyophilized biological preparation for instillation containing cells of Streptococcus pyogenes (Group A, type 3) Su strain treated with benzylpenicillin.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Protara TherapeuticsLead Sponsor

4 Previous Clinical Trials

148 Total Patients Enrolled

Chief Scientific Operations OfficerStudy DirectorProtara Therapeutics

4 Previous Clinical Trials

148 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently opportunities to join this trial?

"Affirmative. Clinicaltrials.gov reflects that this clinical trial is actively recruiting participants, having been posted on September 15th 2023 and modified most recently on the 21st of the same month. 102 patients are being accepted at 5 separate locations."

Answered by AI

What is the scope of participants in this clinical study?

"Protara Therapeutics, the sponsor of this study, is recruiting 102 qualified participants from medical centres such as Carolina Urologic Research Center in Myrtle Beach and Urology Associates PC in Nashville."

Answered by AI

How many health care facilities are currently hosting this experiment?

"Patients are being enrolled in this trial at Carolina Urologic Research Center, Myrtle Beach, SC; Urology Associates PC, Nashville, TN.; Virginia Urology. Richmond VA., plus two other sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose Expansion, Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer

2023. "Dose Expansion, Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05951179.

All > Bladder Cancer