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A Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy Versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer - MK-3475-866 (KEYNOTE-866)

Studio Clinico

Patologia: Carcinoma della vescica

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico


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
- Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.

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.

Trattamento sperimentale: 

Pembrolizumab + Gemcitabine + Cisplatin + Surgery

Participants received 4 preoperative cycles of pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative pembrolizumab.

Trattamento di controllo: 

Placebo + Gemcitabine + Cisplatin + Surgery

Participants received 4 preoperative cycles of placebo to pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative placebo to pembrolizumab.

Obiettivi primari dello studio: 

Pathologic Complete Response (pCR) Rate [ Time Frame: Up to approximately 15 Weeks (Time of surgery) ]
  pCR rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0pT0N0) in examined tissue from RC and PLND, as assessed by blinded independent central review (BICR).

Event-Free Survival (EFS) [ Time Frame: Up to approximately 71 months ]
  EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence based on BICR assessments, or death due to any cause.

Centri partecipanti

Nord Italia

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

Riferimento: Dr.ssa Elena Verzoni
Telefono: 0223904449


A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO


Centro Italia

Azienda Ospedaliera San Camillo Forlanini
Via Portuense 332 - 00149 Roma - RM


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

Telefono: 0630155202


AO S. Maria Terni
Via Tristano di Joannuccio 1 - 05100 Terni - TR

Riferimento: Dr. Sergio Bracarda
Telefono: 0744205631


Sud Italia e isole

AOU Policlinico Vittorio Emanuele PO G. Rodolico
Via S. Sofia 78 - 95123 Catania - CT

Riferimento: Dr. Hector Soto Parra
Telefono: 0953781496


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

Riferimento: Dr.ssa Rosa Tambaro
Telefono: 0352673694

Informazioni Generali


Numero di iscrizione a registro: 2018-003808-39

Data di inserimento: 21.04.2021


Merck Sharp & Dohme Corp.



Principal Investigator ITALIA

Istituto Nazionale Tumori - IRCCS Fondazione Pascale, Napoli

Riferimento: Dr.ssa Rosa Tambaro

Telefono: 0352673694


Localita: Napoli


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