A phase 3, 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
- Conditions
- Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC)Cancer
- Registration Number
- ISRCTN76448481
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 27
1. Be 18 or more years of age at the time of informed consent.
2. Have a histologically confirmed diagnosis (within 90 days of randomisation) of intermediate-risk non-muscle invasive bladder cancer (IR-NMIBC) with at least one of the protocol-defined criteria fulfilled.
3. Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumour tissue testing (from transurethral resection of bladder tumour [TURBT] tissue), as determined by central or local testing.
4. 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 randomised into that arm.
5. Visible papillary disease must be fully resected prior to randomisation and absence of disease must be documented at Screening cystoscopy. The same method for visualising disease at Screening cystoscopy should be used throughout for the participant (white light versus enhanced assessment method).
6. 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.
7. Have an Easter Cooperative Oncology Group (ECOG) performance status of 0 to 2.
8. Have an estimated glomerular filtration rate (eGFR), based on the Modification of Diet in Renal Disease (MDRD) 4-variable formula of greater than 30 millilitres (mL) per minute (min).
9. Meet the protocol-defined hepatic function criteria.
10. Participants should have adequate bone marrow function, as defined within the protocol.
11. While on study treatment and for 6 months after the last dose of study treatment, a participant must not breastfeed or be pregnant, not donate gametes (i.e., eggs or sperm) or freeze for future use for the purposes of assisted reproduction, and wear an external condom, as applicable. If of childbearing potential, participants must have a negative highly sensitive pregnancy test at Screening and within 24 hours before the first dose of study treatment, and agree to further pregnancy tests, and practice at least 1 highly effective method of contraception (if oral contraceptives are used, a barrier method of contraception must also be used). If a participant’s partner is of childbearing potential, the partner must practice a highly effective method of contraception unless the participant is vasectomised.
12. Must sign an informed consent form (ICF; or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study and agree to store samples for research when appropriate.
13. Be willing and able to adhere to the lifestyle restrictions specified in the protocol.
1. Known allergies, hypersensitivity, or intolerance to any study component or its Excipients.
2. Presence of any bladder or urethral anatomic feature 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.
3. Polyuria with recorded 24-hour urine volumes greater than 4000 millilitres (mL).
4. Current indwelling urinary catheters, however, intermittent catheterisation is acceptable.
5. Had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (transurethral resection of bladder tumour [TURBT] is not considered major surgery).
6. Has active bladder stones or persistent risk of bladder stones.
7. Concurrent urinary tract infection (UTI) as defined in the study protocol.
8. Any cardiovascular dysfunction as defined in the study protocol.
9. Histologically confirmed diagnosis of high-risk (HR) non-muscle invasive bladder cancer (NMIBC) or muscle-invasive bladder cancer (MIBC), locally advanced, non-resectable, or metastatic urothelial carcinoma at any time prior to enrolment.
10. Has or had urothelial carcinoma (UC) outside of the urinary bladder or has a histological variant of UC.
11. HIV-positive participants with AIDS-related symptoms.
12. Received an investigational treatment for bladder cancer after TURBT for the current NMIBC diagnosis or within 4 weeks or the agent/therapy washout period, whichever is longer, before the planned first dose of study treatment, or is currently enrolled in an investigational study.
13. Received adjuvant induction intravesical chemotherapy within 6 months of current diagnosis.
14. Received prior intravesical treatment with immunotherapy including BCG within 2 years prior to randomisation.
15. Received prior treatment with an fibroblast growth factor receptor (FGFR) inhibitor.
16. Not recovered from adverse events (AEs) associated with any prior surgery or prior anticancer therapy (except toxicities which are not clinically significant).
17. Symptomatic, active infection requiring systemic therapy.
18. Evidence of current bladder perforation by cystoscopy or imaging.
19. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.
20. The participant is unable to comply with the requirements of the protocol, including any factors that are likely to affect the participant’s return for scheduled visits and follow-up.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method