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

Phase 3Not Yet RecruitingNCT07480356

Protara Therapeutics284 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

284

Conditions

Bladder (Urothelial, Transitional Cell) Cancer Non-Muscle Invasive Bladder Carcinoma Non-muscle Invasive Bladder Cancer With Carcinoma in Situ

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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)

Time frame: Month 6

Secondary Outcomes

Duration of high-grade complete response

Duration of high-grade complete response of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: Month 6

Event-free survival

Event-free survival (EFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

Time frame: Up to Month 60

Recurrence-free survival

Recurrence-free survival (RFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

Time frame: Up to Month 60

Progression-free survival

Progression-free survival (PFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

Time frame: 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

Time frame: Up ro Month 60

Overall survival

Overall survival (OS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

Time frame: Up to Month 60

Disease-specific survival

Disease-specific survival (DSS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

Time frame: Up to Month 60

Time to cystectomy

Time to cystectomy of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

Time frame: 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

Time frame: Up to Month 60

Time to progression

Time to progression of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

Time frame: Up to Month 60

Time to disease worsening

Time to disease worsening of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

Time frame: Up to Month 60

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts