Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in Participants With High-risk Non-muscle-invasive Bladder Cancer With Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)
Interventional
Phase 3
Janssen Research & Development, LLC (Voir sur ClinicalTrials)
septembre 2025
mars 2032
14 octobre 2026
The main purpose of this study is to compare the disease-free survival (the length of
time after randomization that a participant survives without any signs or symptoms of the
cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated
participants receiving treatment with TAR-210 versus investigator's choice of
intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer
(HR-NMIBC).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Yohann LORIOT | 13/10/2026 23:25:34 | Contacter | ||
Critères
Tous
- Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC
(defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if
urothelial differentiation is predominant. However, neuroendocrine, and small cell
variants will be excluded
- 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
- All visible tumor completely resected prior to randomization. Urine cytology must
not be positive or suspicious for high grade UC before randomization. For
participants with lamina propria invasion (T1) on the screening biopsy/TURBT,
muscularis propria must be present to rule out MIBC
- Participants must have had either: a. Adequate Induction (5 of 6 doses) and either 2
of 3 doses of Maintenance or 2 of 6 doses of second Induction of BCG with high-grade
T1 disease at first disease assessment after induction or high-grade Ta/any T1
disease within 6 months after last BCG (BCG-unresponsive population); b. had
adequate induction (5 or 6 doses) with or without maintenance BCG with high-grade
Ta/any T1 disease within 12 months after last BCG excluding BCG-unresponsive
(BCG-experienced population); or c. been unable to complete an induction course of
BCG with at least 5 doses due to grade >= 2 toxicity requiring BCG discontinuation
(BCG intolerant population)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1,
or 2
- Must be ineligible for or refusing radical cystectomy (RC)
Exclusion criteria:
- Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC
recurrence to randomization. Additionally, presence or history of histologically
confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic
urothelial carcinoma (that is [i.e.], T2, T3, T4, N+, and/or M+)
- Active malignancies (i.e., progressing or requiring treatment change in the last 24
months) other than the disease being treated under study. Allowed recent second or
prior malignancies: a. Any malignancy that was not progressing nor requiring
treatment change in the last 12 months; b. Malignancies treated within the last 12
months and considered at very low risk for recurrence for example (e.g.):
non-melanoma skin cancers (treated with curative therapy or localized melanoma
treated with curative surgical resection alone), non-invasive cervical cancer,
breast cancer (adequately treated lobular CIS or ductal CIS, localized breast cancer
and receiving antihormonal agents), localized prostate cancer ([N0, M0] with a
Gleason score less than or equal to [<=] 7a, treated locally only [radical
prostatectomy/radiation therapy/focal treatment]) and other malignancy that is
considered at minimal risk of recurrence
- Presence of any bladder or urethral anatomic feature that, in the opinion of the
investigator, may prevent the safe placement, indwelling use, or removal of TAR 210
- A history of clinically significant polyuria with recorded 24 hour urine volumes
greater than (>) 4,000 milliliters (mL)
- Indwelling catheters are not permitted; however, intermittent catheterization is
acceptable