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Cancer Vaccine

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

Phase 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

Must not have

Any history of ≥ T2 bladder cancer that existed at any point in time in the subject's history

Predominant (defined as > 50%) adenocarcinoma, squamous cell carcinoma, or histological variants including plasmacytoid, sarcomatoid, or squamous components according to central review

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to month 60

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had bladder cancer that was larger than a T2 tumor at some point.

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My cancer is mostly made up of a specific type of cell.

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I have never had cancer spread to my lymph nodes or other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to month 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to month 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to month 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

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

Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-NMIBC24

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TARA-002

2023

Completed Phase 1

~10

0 / 5Eligibility criteria met