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Studio di fase III, randomizzato, in doppio cieco volto a confrontare trastuzumab più chemioterapia e pembrolizumab con trastuzumab più chemioterapia e placebo come trattamento in prima linea in soggetti con adenocarcinoma gastrico avanzato o adenocarcinoma della giunzione gastro-esofagea HER2-positivo - KEYNOTE-811

Studio Clinico

Patologia: Neoplasie dello stomaco

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Monocentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: No

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2 positive gastric or GEJ adenocarcinoma
- HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with in-situ hybridization positive (ISH+) or fluorescent in-situ hybridization (FISH), as assessed by central review on primary or metastatic tumor
- Has measurable disease as defined by RECIST 1.1 as determined by the site investigator
- Male participants must agree to use approved contraception
- Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the first dose of trial treatment
- Has a life expectancy of greater than 6 months
- Has adequate organ function

Criteri di esclusione: 

- Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ cancer
- Has had major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment
- Has had radiotherapy within 14 days of randomization
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
- Has a known history of active tuberculosis (TB; Mycobacterium tuberculosis)
- Has an active infection requiring systemic therapy
- Has poorly controlled diarrhea
- Accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment. If the participant is receiving diuretic drugs for other reasons, it is acceptable
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
- Has peripheral neuropathy > Grade 1
- Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization or treatment allocation
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 7 months after the last dose of trial treatment
- Has active or clinically significant cardiac disease
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab, trastuzumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum-containing products
- Has had an allogeneic tissue/solid organ transplant
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, Cluster of Differentiation 137 [CD137])

Trattamento sperimentale: 

pembrolizumab+trastuzumab+chemioterapia

Trattamento di controllo: 

placebo+trastuzumab+chemioterapia

Obiettivi primari dello studio: 

Confrontare la PFS tra i gruppi di trattamento.

Ipotesi (I1): pembrolizumab in combinazione con trastuzumab più chemioterapia è superiore a trastuzumab più la sola chemioterapia in termini di PFS, valutata mediante revisione centrale indipendente in cieco (BICR) utilizzando i criteri RECIST, versione 1.1.

Confrontare l’OS tra i gruppi di trattamento.

Ipotesi (I2): pembrolizumab in combinazione con trastuzumab più chemioterapia è superiore a trastuzumab più la sola chemioterapia

Obiettivi secondari dello studio: 

Confrontare l’ORR tra i gruppi di trattamento.

Ipotesi (I3): pembrolizumab in combinazione con trastuzumab più chemioterapia è superiore a trastuzumab
più la sola chemioterapia, valutato mediante BICR utilizzando i criteri RECIST, versione 1.1.

Stimare la DOR, valutata mediante BICR, secondo i criteri RECIST, versione 1.1

Valutare la sicurezza e la tollerabilità di pembrolizumab in combinazione con trastuzumab più chemioterapia in base alla percentuale di eventi avversi (EA)

Centri partecipanti

Nord Italia

Cliniche Humanitas Gavazzeni
Via Gavazzeni 21 - 24125 Bergamo - BG
Site stage: start-up

Riferimento: Dr. Giordano Beretta
Telefono: 0354204761
Email: giordano.beretta@gavazzeni.it

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

Riferimento: Dr. Nicola Fazio
Telefono: 0257489258

 

A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO
Site stage: start-up

Riferimento: Dr. Gabriele Luppi
Telefono: 0594225646
Email: comsegreteria@policlinico.mo.it

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD

Riferimento: Dr.ssa Sara Lonardi
Telefono: 0498215910
Email: sara.lonardi@iov.veneto.it

 

Centro Italia

Ospedale Civile di Pescara
Via Fonte Romana 8 - 65124 Pescara - PE

Riferimento: Dr. Carlo Garufi
Telefono: 0854252517
Email: carlo.garufi@ausl.pe.it

 

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

Riferimento: Dr. Lorenzo Fornaro

 

Sud Italia e isole

Università degli Studi Magna Græcia
Viale Europa - 88100 Germaneto - CZ
A.O.U. Mater Domini - Campus Universitario 'S. Venuta'. U.O.C. Oncologia Medica

Riferimento: Prof. Pierosandro Tagliaferri
Telefono: 09613694324
Email: tagliaferri@unicz.it

 

AOU degli studi della Campania Luigi Vanvitelli
Piazza Luigi Miraglia 2 - 80138 Napoli - NA
Site stage: start-up

Riferimento: Prof. Ferdinando De Vita
Email: ferdinando.devita@unicampania.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2018-000224-34

Data di inserimento: 06.12.2018

Data di aggiornamento: 12.02.2019

Promotore

Merck Sharp & Dohme Corp.

Riferimento: Dr.ssa Nirvana Frazzini

Email: nirvana.frazzini.ext@merck.com

CRO

IQVIA

Principal Investigator ITALIA

Mater Domini - Campus Universitario 'S. Venuta', Località Germaneto (Catanzaro)

Riferimento: Prof. Pierfrancesco Tassone

Telefono: 09613697029

Email: tassone@unicz.it

Localita: Germaneto (CZ)

 

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