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SunRISe-4 - A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy.

Studio Clinico

Patologia: Carcinoma della vescica

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: II Randomizzato

Linee di trattamento: Adiuvante/neoadiuvante

Criteri di inclusione: 

- Histologically proven, cT2-T4a N0, M0 infiltrating urothelial carcinoma of the bladder. Initial diagnosis must have been within 120 days of randomization date. Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial predominance. However, the presence of small cell or neuroendocrine variants will make a participant ineligible
- Participants with no residual tumor, or intravesical tumor size of less than or equal to (<=)3 centimeter (cm) following transurethral resection of bladder tumor (TURBT) are eligible; debulking TURBT for any residual disease is encouraged but not mandated. Participants with persistent tumors greater than (>)3 cm at screening must undergo a second debulking, re-staging TURBT. Participants will be ineligible if any individual tumor is >3 cm after debulking TURBT
- Deemed eligible for and willing to undergo RC by the operating urologist
- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1
- Thyroid function tests within normal range or stable on hormone supplementation per investigator assessment. Investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal tests results
- All adverse events associated with any prior surgery must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (<) 2 prior to randomization.

Criteri di esclusione: 

- Must not have received prior systemic chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to starting study treatment
- Participants must not have evidence of cT4b, or N1-3, or M1 disease based on central radiology staging (chest, abdomen, and pelvis must be performed using computed tomography [CT] or magnetic resonance imaging [MRI]) within 42 days prior to randomization
- 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-200
- Prior systemic chemotherapy for urothelial cell carcinoma of the bladder at any time
- Currently participating or has participated in a study of an investigational agent and received study therapy or investigational device within 4 weeks prior to enrollment
- Participants with evidence of bladder perforation during diagnostic cystoscopy. Participant is eligible if perforation has resolved prior to dosing.

Trattamento sperimentale: 

Cohort 1: TAR-200 + Cetrelimab
Cohort 2: Cetrelimab

Trattamento di controllo: 

-

Obiettivi primari dello studio: 

The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.

Centri partecipanti

Nord Italia

Azienda Sanitaria 3 genovese - Villa Scassi
Corso Scassi 1 - 16149 Genova-Sanpierdarena - GE

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI

 

Ospedale di Carpi e Mirandola
Via G. Molinari 2 - 41012 Carpi - MO
Ospedale Civile Ramazzini

 

AOU Città della Salute e della Scienza di Torino
Corso Bramante 88 - 10126 Torino - TO

 

Centro Italia

AOU Pisana - Santa Chiara
Via Roma 67 - 56126 Pisa - PI

 

Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM

 

Sud Italia e isole

A.O.S.G. Moscati
Contrada Amoretta - 83100 Avellino - AV

 

Santa Maria delle Grazie - Pozzuoli
Via Domitiana - 80078 La Schiana - Pozzuoli - NA
ASL Napoli 2 Nord

 

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2020-005565-13 - NCT04919512

Data di inserimento: 11.01.2024

Promotore

Janssen Research & Development, LLC

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd

 

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