ServiziMenu principale

<< Torna a "Tutti gli studi"

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 (KEYNOTE-676)

Studio Clinico

Patologia: Carcinoma della vescica

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

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 A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE
Clinica Urologica

Riferimento: Prof. Carlo Terrone
Email: carlo.terrone@uniupo.it

 

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI

 

AOUI Verona - Borgo Trento
Piazzale Aristide Stefani 1 - 37126 Verona - VR

 

Centro Italia

AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI

 

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM

 

Sud Italia e isole

Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA

 

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

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

 

<< Torna a "Tutti gli studi"