ServiziMenu principale

<< Torna a "Tutti gli studi"

MK3475-B15 - A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)

Studio Clinico

Patologia: Carcinoma della vescica

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

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

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

Riferimento: Dr.ssa Valentina Guadalupi
Telefono: 0223903811
Email: valentina.guadalupi@istitutotumori.mi.it

 

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

Riferimento: Prof. Andrea Necchi
Email: necchi.andrea@unisr.it

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
Oncologia Medica 1

Riferimento: Dr. Marco Maruzzo
Email: marco.maruzzo@iov.veneto.it

 

A.O.U San Luigi Gonzaga
Regione Gonzole 10 - 10043 Orbassano - TO

Riferimento: Prof.ssa Consuelo Buttigliero
Email: consuelo.buttigliero@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

Ospedale Riuniti Umberto I - Lancisi-Salesi
Via Conca 71 - 60020 Ancona - AN

Riferimento: Prof.ssa Rossana Berardi
Telefono: 0715964169
Email: Rossana.Berardi@ospedaliriuniti.marche.it

 

Sud Italia e isole

A.O. per l’Emergenza Cannizzaro di Catania
Via Messina 829 - 95126 Catania - CT

Riferimento: Dr.ssa Giuseppa Scandurra
Telefono: 0957262518
Email: giusy.scandurra@gmail.com

 

Santa Maria delle Grazie - Pozzuoli
Via Domitiana - 80078 La Schiana - Pozzuoli - NA

Riferimento: Dr. Gaetano Facchini
Telefono: 3493150098
Email: gaetano.facchini@aslnapoli2nord.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2020-003106-31

Data di inserimento: 16.06.2022

Data di aggiornamento: 02.10.2023

Promotore

Merck Sharp & Dohme LLC

CRO

/

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd

 

<< Torna a "Tutti gli studi"

Apri