A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Persistent or Recurrent Following BCG Induction (MK-3475-676 / KEYNOTE-676)
Studio Clinico
Patologia: Carcinoma della vescica
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: Sì
Fase di studio: III
Richiesta mandatoria di tessuto: Sì
Linee di trattamento: Seconda linea
Criteri di inclusione:
• Has histologically-confirmed diagnosis of non-muscle invasive (T1, high grade Ta and/or CIS) transitional cell carcinoma (TCC) of the bladder
• Has been treated with one adequate course of BCG induction therapy for the treatment of HR NMIBC
• Following adequate BCG induction therapy, must have persistent or recurrent HR NMIBC
• Has undergone cystoscopy/ transurethral resection of bladder tumor (TURBT) to remove all resectable disease
• Has provided tissue for biomarker analysis
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Has adequate organ function
• Male participants must agree to use approved contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period
• Female participants who are not pregnant, not breastfeeding, and either not a woman of child bearing potential (WOCBP) or are a WOCBP who agrees to use approved contraception during the treatment period and for at least 120 days after the last dose of study treatment
Criteri di esclusione:
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
Trattamento sperimentale:
Pembrolizumab +BCG
Trattamento di controllo:
BCG
Centri partecipanti
Nord Italia
Ospedale di Bolzano
Via Lorenz Boehler 5 - 39100 Bolzano - BZ
IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
Riferimento: Dr.ssa Elena Verzoni
Telefono: 0223904449
Email: elena.verzoni@istitutotumori.mi.it
Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
Riferimento: Prof. Andrea Necchi
Telefono: 0226435789
Email: necchi.andrea@unisr.it
AO - Ordine Mauriziano
Largo Turati 62 - 10128 Torino - TO
Riferimento: Prof. Massimo Di Maio
Telefono: 0115082032
Email: massimo.dimaio@unito.it
AOUI Verona - Borgo Trento
Piazzale Aristide Stefani 1 - 37126 Verona - VR
Riferimento: Dr. Andrea Zivi
Email: oncologia.gu.verona@aovr.veneto.it
Centro Italia
Istituto Toscano Tumori Ospedale San Donato
Via Pietro Nenni 20 - 52100 Arezzo - AR
Riferimento: Dr.ssa Alketa Hamzaj
Telefono: 0575255452
Email: alketa.hamzaj@uslsudest.toscana.it
Ospedale Clinicizzato SS Annunziata
Via Dei Vestini 5 - 66013 Chieti - CH
AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI
Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
Riferimento: Prof. Giampaolo Tortora
Telefono: 0630155202
Email: oncomedsperimentali@policlinicogemelli.it
Sud Italia e isole
Ospedale Buccheri La Ferla
Via M. Marine 197 - 90123 Palermo - PA
Informazioni Generali
Protocollo
Numero di iscrizione a registro: 2018-001967-22
Data di inserimento: 30.09.2019
Data di aggiornamento: 27.03.2023
Promotore
Merck Sharp & Dohme Corp.
CRO
NA
Principal Investigator ITALIA
Ospedale Policlinico San Martino, Genova
Riferimento: Prof. Carlo Terrone
Telefono: 00000
Email: carlo.terrone@uniupo.it
Localita: Genova