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A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma - KEYNOTE585

Studio Clinico

Patologia: Neoplasie dello stomaco, Tumori dell’esofago

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: No

Linee di trattamento: Adiuvante/neoadiuvante

Criteri di inclusione: 

  • 18 Years and older (Adult, Senior)
  • M/F
  • Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes - N+ (clinical nodes) without evidence of metastatic disease.
  • Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.
  • Is willing to provide tissue from a tumor lesion at baseline and at time of surgery.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 within 3 days prior to the first dose of study treatment.
  • Has adequate organ function.
  • Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy.
  • Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.
  • Has life expectancy of greater than 6 months.

Criteri di esclusione: 

  • No healthy volunteers
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
  • Has received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], tumor necrosis factor receptor superfamily member 4 [OX-40], necrosis factor receptor superfamily member 9 [CD137]) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial.
  • Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy.
  • Has received prior radiotherapy within 2 weeks of start of study treatment for any other condition.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study treatment.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded.
  • Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients, or to any of the study chemotherapy agents and/or to any of their excipients.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years.
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has a known history of Hepatitis B or known active Hepatitis C virus infection.
  • Has a known history of active tuberculosis (TB).
  • Female participants who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.
  • Male participants who are expecting to father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of chemotherapy.
  • Has received a live vaccine within 30 days prior to the first dose of study treatment.

Trattamento sperimentale: 

Experimental: Pembrolizumab+Chemotherapy
Experimental: Pembrolizumab+FLOT Safety Cohort

Trattamento di controllo: 

Placebo Comparator: Placebo+Chemotherapy
Placebo Comparator: Placebo+FLOT Safety Cohort

Obiettivi primari dello studio: 

- Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]
- OS is defined as the time from randomization to death due to any cause.
- Event-free Survival (EFS) [ Time Frame: Up to approximately 2 years ]
- EFS is defined as the time from randomization to the first of the following events: radiographic disease progression per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1); local or distant recurrence as assessed by computer tomography (CT) scan or biopsy if indicated (for participants who are disease free after surgery); or death due to any cause. A second primary malignancy is not considered as an EFS event.
- Pathological Complete Response (pathCR) Rate [ Time Frame: Up to 6 weeks after completion of 3 cycles of neoadjuvant treatment (Up to 15 weeks) ]
- PathCR rate is defined as the percentage of participants having pathCR. pathCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes.
- Adverse Events (AEs) [ Time Frame: Up to approximately 27 months ]
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.
- Study Treatment Discontinuations Due to AEs [ Time Frame: Up to approximately 2 years ]
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.

Centri partecipanti

Nord Italia

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

Riferimento: Dr.ssa Maria Di Bartolomeo
Telefono: 0223902149
Email: maria.dibartolomeo@istitutotumori.mi.it

 

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

Riferimento: Prof. Armando Santoro
Telefono: 0282246280

 

IRCCS Policlinico San Donato
Via Morandi 30 - 20097 San Donato Milanese - MI
Oncologia Medica II

Riferimento: Dr. Alberto GianLuigi Luporini
Telefono: 0252774435
Email: alberto.luporini@grupposandonato.it

 

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

Riferimento: Dr. Gabriele Luppi
Telefono: 0594223200

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
SS Oncologia Gastroenterologica

Riferimento: Dr.ssa Sara Lonardi
Telefono: 0498215953
Email: sara.lonardi@iov.veneto.it

 

Azienda Ospedaliera Santa Maria della Misericordia
Piazzale Santa Maria della Misericordia 15 - 33100 Udine - UD

Riferimento: Dr. Giovanni Gerardo Cardellino
Telefono: 0434223522

 

Sud Italia e isole

AOU degli studi della Campania Luigi Vanvitelli
Piazza Luigi Miraglia 2 - 80138 Napoli - NA

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

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2016-004408-76 / NCT03221426

Data di inserimento: 02.03.2018

Data di aggiornamento: 11.02.2019

Promotore

Merck Sharp & Dohme Corp.

CRO

N.A.

Principal Investigator ITALIA

SS Tumori Gastrointestinali - Istituto Oncologico Veneto - Padova

Riferimento: Dr.ssa Sara Lonardi

Telefono: 0498215953

Email: sara.lonardi@iov.veneto.it

Localita: Padova

 

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