A Phase III, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations
Study Identifier:
42756493BLC3004
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
Study Contact Information:
Recruitment Complete
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Study Summary
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.
To evaluate TAR-210, an erdafitinib intravesical drug-releasing system, versus intravesical chemotherapy in patients with fibroblast growth factor receptors (FGFR)-altered intermediate-risk NMIBC
Main objective:
To compare DFS between Group A and Group B.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
III
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruitment Complete
Requirements information
Inclusion criteria
- 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. Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy Can have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment Have an Eastern Cooperative Oncology Group performance status of 0 to 2 CFDA Be 18 years or older at the time of informed consent. 2 Patients with histologically confirmed intermediate-risk non-muscle invasive bladder cancer (IR-NMIBC) who meet at least one of the required criteria and have one or more of the required risk factors. 3 Patients with a predisposing fibroblast growth factor receptor (FGFR) mutation or fusion must be tested by urine testing or tumor histology (central or local testing). 4 Participants had to be willing to undergo all study procedures and receive assigned treatment, including intravesical chemotherapy instillations if randomized to that treatment group. 5 Visible papillary disease must have been completely resected before randomization, and the absence of disease must have been documented on screening cystoscopy. 6 Previous or concurrent second malignancies (other than the study disease) were permitted if their natural history or treatment was unlikely to interfere with the safety of any study endpoint or the effectiveness of the study treatment. 7 The Eastern Cooperative Oncology Group (ECOG) score was 0 to 2. 8 The estimated glomerular filtration rate (eGFR) calculated according to the Modification of Diet in Renal Disease (MDRD4) variable formula was greater than (>) 30 milliliters per minute (mL/min). 9 The results of liver function tests met the requirements. 10 Participants' bone marrow function should meet the requirements. 11 While receiving study treatment and for 6 months after the last dose of study treatment, participants must: - not breastfeed or become pregnant, - not donate gametes (i.e. eggs or sperm) or freeze them for future use in assisted reproduction, - wear external condoms, - if of childbearing potential: o have a negative high-sensitivity pregnancy test at Screening and within 24 hours before the first dose of study treatment and agree to further pregnancy testing, o use at least one highly effective method of contraception, - if the participant's partner is of childbearing potential, the partner must use a highly effective method of contraception unless the participant has had a vasectomy. 12 An informed consent form (ICF) must be signed, indicating that the participant understands the purpose of the study and the required procedures, is willing to participate in the study, and agrees to store the sample for research when appropriate. 13 Be willing and able to adhere to the lifestyle restrictions specified in the program.
Exclusion criteria
- 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 Had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (TURBT is not considered major surgery) CFDA Known allergy or intolerance to any of the study ingredients or their excipients. 2Any bladder or urethral anatomical features may prevent safe insertion, placement, or removal of TAR-210 or bladder chemotherapy instillation via a urethral catheter. 3Polyuria, 24-hour recorded urine volume greater than 4000 ml. 4An indwelling urinary catheter is currently in place, but intermittent catheterization is acceptable. 5Have had major surgery or trauma and/or have not fully recovered within 4 weeks before first use of this medication. 6Have active bladder stones or are at persistent risk for bladder stones, such as severe bladder outlet obstruction or residual urine volume greater than 350 mL after urination. 7Complicated urinary tract infection (UTI) is defined as a symptomatic infection with a positive urine culture. 8History of cardiovascular disease within 3 months before first receiving study treatment. 9Patients with histologically confirmed high-risk non-muscle invasive bladder cancer (HR NMIBC) or muscle invasive bladder cancer (MIBC), locally advanced, unresectable or metastatic urothelial carcinoma at any time before enrollment. 10Have or have had extravesical urothelial carcinoma (UC) or a histologic variant of UC. 11Human immunodeficiency virus (HIV) positive and with symptoms associated with acquired immunodeficiency syndrome (AIDS). 12Patients who have been diagnosed with bladder cancer after transurethral resection of bladder tumors (TURBT) or have received investigational treatment for bladder cancer within 4 weeks prior to the first planned dose of study treatment or during the agent/treatment washout period (whichever is longer) or are currently receiving investigational treatment. 13Received intravesical adjuvant/induction chemotherapy within 6 months of current diagnosis. 14Receipt of intravesical immunotherapy, including Bacillus Calmette-Guerin (BCG), within 2 years before randomization. 15Have received previous treatment with FGFR inhibitors. 16No recovery from any previous surgery or previous anticancer treatment-related adverse events (AEs). 17Symptomatic, active infection requiring systemic therapy. 18Bladder perforation is detected by cystoscopy or imaging studies. 19Any circumstances in which the researcher believes that participation in the project is not in the best interest of the participant, or which may prevent, limit, or confound the protocol-mandated assessment. 20The participant is unable to comply with the protocol requirements.
- Substudy:
- - Previous diagnosis of histologically confirmed urothelial bladder carcinoma at any time prior to current qualifying diagnosis
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Neal Shore
Status
Recruiting
Condition(s) Treated at Site
Bladder