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A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma and Complete Radiological Response After Surgical Resection or Local Ablation (MK-3475-937 / KEYNOTE-937)

Studio Clinico

Patologia: Epatocarcinoma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Adiuvante/neoadiuvante

Criteri di inclusione: 

- Has a diagnosis of HCC by radiological criteria and/or pathological confirmation.
- Has an eligibility scan (CT of the chest, triphasic CT scan or MRI of the abdomen, and CT or MRI of the pelvis) confirming complete radiological response ≥4 weeks after complete surgical resection or local ablation. Randomization needs to occur within 12 weeks of the date of surgical resection or local ablation.
- Has no radiologic evidence of disease prior to enrollment.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 within 7 days prior to Cycle 1, Day 1.
- Has a Child-Pugh class A liver score (5 to 6 points) within 7 days prior to Cycle 1, Day 1.
- Has alpha fetoprotein (AFP) concentration lower than 400 ng/mL within 28 days prior to Cycle 1, Day 1.
- Has controlled hepatitis B (Hep B).
- Has recovered adequately from toxicity and/or complications from the local intervention (surgical resection or local ablation) prior to starting study treatment.
- If male, contraceptive use should be consistent with local regulations.
- If female, is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); or 2) Is a WOCBP and using a contraceptive method that is highly effective or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (a WOCBP must have a negative pregnancy test within 72 hours before the first dose of study treatment).
- If undergoing surgical resection, has submitted a tumor tissue sample during Screening.
- Has adequate organ function.

Criteri di esclusione: 

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Trattamento sperimentale: 

Pembrolizumab

Trattamento di controllo: 

Placebo

Centri partecipanti

Nord Italia

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO

Riferimento: Prof. Giovanni Brandi
Telefono: 0512143838
Email: giovanni.brandi@unibo.it

 

IRCCS Ca' Granda Ospedale Maggiore Policlinico
Via Francesco Sforza 35 - 20122 Milano - MI
N.B.: Arruolamento pazienti non ancora attivo

Riferimento: Prof. Pietro Lampertico
Telefono: 0255035432
Email: pietro.lampertico@unimi.it

 

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

Riferimento: Dr. Vincenzo Mazzaferro
Telefono: 0223902338
Email: vincenzo.mazzaferro@istitutotumori.mi.it

 

AO - Ordine Mauriziano
Largo Turati 62 - 10128 Torino - TO

Riferimento: Prof. Massimo Di Maio
Telefono: 0115082032
Email: massimo.dimaio@unito.it

 

Centro Italia

AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI

Riferimento: Prof. Lorenzo Antonuzzo
Telefono: 0557947298
Email: antonuzzol@aou-careggi.toscana.it

 

AOU Pisana - Santa Chiara
Via Roma 67 - 56126 Pisa - PI

Riferimento: Prof. Gianluca Masi
Telefono: 050992070
Email: g.masi@ao-pisa.toscana.it

 

Sud Italia e isole

ASL Napoli 1 Centro - Ospedale del Mare
Via Enrico Russo - 80147 Napoli - NA

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2018-004800-20

Data di inserimento: 27.02.2020

Data di aggiornamento: 09.05.2022

Promotore

Merck Sharp & Dohme Corp.

CRO

NA

Principal Investigator ITALIA

Azienda Ospedaliero Universitaria Pisana - Stabilimento di Santa Chiara

Riferimento: Prof. Gianluca Masi

Telefono: 050992070

Email: g.masi@ao-pisa.toscana.it

Localita: Pisa

 

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