Health TrialsbyHealthPanel

A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

ConditionNon-Muscle Invasive Bladder Neoplasms
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

About this trial

The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Main study only: Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent, b. Ta LG/G2: primary or recurrent and c. Greater than or equal to (>=) 1 of the following risk factors: i. Multiple Ta LG tumors, ii. Solitary LG tumor >= 3 cm, iii. Early recurrence (less than [<] 1 year), iv. Frequent recurrence (greater than [>] 1 per year), v. Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor)

Substudy only: Have a histologically confirmed new diagnosis (within 90 days of randomization) of IR-NMIBC for whom MMC is deemed the therapy of choice according to local standard of care with at least 1 of the following criteria fulfilled: a. Ta LG/G1, b. Ta LG/G2, and >=1 of the following risk factors: i) Multiple Ta LG tumors, ii) Solitary LG tumor >=3 cm

Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing

Participants must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence/progression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm.

Disqualifiers

Known allergies, hypersensitivity, or intolerance to any study component or its excipients, including: a. Erdafitinib excipients; b.TAR-210 drug delivery system constituent materials ; c. urinary placement catheter materials; d. MMC or chemically related drugs; e. Gemcitabine or chemically related drugs

Presence of any bladder or urethral anatomic feature (that is, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-210 or passage of a urethral catheter for intravesical chemotherapy

Polyuria with recorded 24-hour urine volumes > 4000 milliliters (mL)

Current indwelling urinary catheters, however, intermittent catheterization is acceptable

Trial design

Design model

Parallel

Treatments tested in this trial

  • TAR-210

    Combination product

    TAR-210 will be administered intravesically.

  • Gemcitabine

    Drug

    Gemcitabine will be administered intravesically.

  • MMC

    Drug

    MMC will be administered intravesically.

Treatment groups

641 Participants
are divided into 4 treatment groups
Group A: Main Study: Group A: TAR-210Experimental treatment 1 intervention
Group B: Main Study: Group B: MMC or GemcitabineActive comparator 2 interventions
Group C: Substudy: Group A: TAR-210Experimental treatment 1 intervention
Group D: Substudy: Group B: MMCActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Disease Free Survival (DFS)

DFS is measured as the time from randomization to the date of the first documented recurrence of Ta non-muscle invasive bladder cancer (NMIBC) of any grade, disease progression, or death due to any cause, whichever occurs first.

Time frame
From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months)

Secondary outcomes

1

Time to next Treatment (TTNT)

TTNT is measured as the time from randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer.

Time frame
From randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer (approximately 4 years and 2 months)
2

High Grade Recurrence-free Survival (HG RFS)

HG RFS is measured as the time from randomization to the date of first documented evidence of HG NMIBC or death, whichever occurs first

Time frame
From randomization to the date of first documented evidence of HG NMIBC or death (approximately 4 years and 2 months)
3

Progression Free Survival (PFS)

PFS is measured as the time from randomization to the date of first documented evidence of disease progression or death, whichever occurs first.

Time frame
From randomization to the date of first documented disease progression or death (approximately 4 years and 2 months)
4

Number of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment

Number of diagnostic and therapeutic invasive urological interventions after study treatment, that is, endoscopic procedures (e.g., cystoscopies, transurethral resection of bladder tumors (TURBTs), ureteroscopies, urethral interventions, urethral stricture/bladder neck incision), catheterization (intravesical, suprapubic), intravesical treatments, major surgeries (e.g., radical cystectomy, simple cystectomy, urethroplasty) will be reported.

Time frame
From study treatment completion up to trial discontinuation (approximately 4 years and 2 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Janssen Research & Development, LLC

Lead sponsor

Source ClinicalTrials.gov
Apply now