Studio Clinico
Patologia: Carcinoma della vescica
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: Sì
Fase di studio: III
Linee di trattamento: Adiuvante/neoadiuvante
Criteri di inclusione:
- Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology
- Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of the chest/abdomen/pelvis
- Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND)
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have adequate organ function
Criteri di esclusione:
- Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions
- Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
- Has ≥N2 disease or metastatic disease (M1) as identified by imaging
- Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol
- Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder
- Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC
- Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention
- Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection. Hepatitis B infection or known active Hepatitis C infection
- Has a known psychiatric or substance abuse disorder
- Has had an allogenic tissue/solid organ transplant
- Has ongoing sensory or motor neuropathy Grade 2 or higher
- Has active keratitis (superficial punctate keratitis) or corneal ulcerations
- Has a history of uncontrolled diabetes defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7% to <8% with associated diabetes symptoms
Trattamento sperimentale:
Experimental: Pembro + Enfortumab Vedotin
Trattamento di controllo:
NA
Centri partecipanti
Nord Italia
Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
Oncologia Medica 1
A.O.U San Luigi Gonzaga
Regione Gonzole 10 - 10043 Orbassano - TO
AOUI Verona - Borgo Trento
Piazzale Aristide Stefani 1 - 37126 Verona - VR
Centro Italia
Ospedale Riuniti Umberto I - Lancisi-Salesi
Via Conca 71 - 60020 Ancona - AN
Sud Italia e isole
Santa Maria delle Grazie - Pozzuoli
Via Domitiana - 80078 La Schiana - Pozzuoli - NA
Informazioni Generali
Protocollo
Numero di iscrizione a registro: 2020-003106-31
Data di inserimento: 16.06.2022
Promotore
Merck Sharp & Dohme LLC
CRO
/
Principal Investigator ITALIA
Riferimento: Dr. Info non disponibile
Telefono: 00000
Email: nd@nd.it
Localita: nd