Informations générales (source: ClinicalTrials.gov)
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 (IR-NMIBC) and Susceptible FGFR Alterations (MoonRISe-1)
Interventional
Phase 3
Janssen Research & Development, LLC (Voir sur ClinicalTrials)
avril 2024
juin 2028
29 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bichat | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital La Pitié-Salpêtrière | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Rangueil - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Chu Rennes Hopital Pontchaillou - 35000 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Clinique de la Croix du Sud - 31130 - Quint-Fonsegrives - France | Contact (sur clinicalTrials) | ||||
| Hôpital Edouard Herriot - 69003 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Louis - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Hospital Center University De Lille - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli Calmettes - 13009 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Polyclinique de Limoges - Francois Chenieux - 87000 - Limoges - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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)
- 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
- 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)
- 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
- 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)