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MK7902-014 - A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared With Standard of Care as First-line Intervention in Participants With Metastatic Esophageal Carcinoma

Studio Clinico

Patologia: Tumori dell’esofago

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Linee di trattamento: Prima linea

Criteri di inclusione: 

  • Has a histologically or cytologically confirmed diagnosis of metastatic squamous cell carcinoma of the esophagus
  • Male participants are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after the last dose of lenvatinib or 90 days after the last dose of chemotherapy, whichever comes last; 7 days after lenvatinib is stopped, if the participant is on pembrolizumab only and is greater than 90 days post chemotherapy, no male contraception is needed
  • Female participant is not pregnant or breastfeeding and is not a woman of childbearing potential (WOCBP) or is a WOCBP using a contraceptive method that is highly effective or is abstinent from heterosexual intercourse as their preferred and usual lifestyle during the intervention period and for at least 120 days after the last dose of pembrolizumab, 30 days after the last dose of lenvatinib, or 180 days after the last dose of chemotherapy, whichever occurs last, and agrees not to donate eggs during this period
  • Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP≤150/90 millimeters of mercury (mm Hg) with no change in antihypertensive medications within 1 week prior to randomization
  • Has adequate organ function

Criteri di esclusione: 

  • Has had previous therapy for locally advanced unresectable or metastatic esophageal cancer
  • Has locally advanced esophageal carcinoma
  • Has metastatic adenocarcinoma of the esophagus
  • Has direct invasion into adjacent organs such as the aorta or trachea
  • Has radiographic evidence of encasement of a major blood vessel, or of intratumoral cavitation
  • Has perforation risks or significant gastrointestinal (GI) bleeding
  • Has had clinically significant hemoptysis within 3 weeks prior to the first dose of study drug or tumor bleeding within 2 weeks prior to the first dose of study intervention
  • Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention
  • Has GI obstruction, poor oral intake, difficulty in taking oral medication, or existing esophageal stent
  • Has had major surgery, open biopsy, or significant traumatic injury within 3 weeks prior to first dose of study interventions
  • Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis
  • Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention; administration of killed vaccines is allowed
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the first dose of study intervention, or has a history of organ transplant, including allogeneic stem cell transplant
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 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; replacement therapy is not considered a form of systemic treatment and is allowed
  • Has a history of non-infectious pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
  • Has poorly controlled diarrhea
  • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
  • Has peripheral neuropathy ≥Grade 2
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of Hepatitis B or know active Hepatitis C virus infection
  • Has a weight loss of >20% within the last 3 months

Trattamento sperimentale: 

Pembro+Lenva+FP or FOLFOX6

Trattamento di controllo: 

Pembro+FP or FOLFOX6

Centri partecipanti

Nord Italia

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

Riferimento: Dr.ssa Maria Di Bartolomeo
Telefono: 0223903066
Email: maria.dibartolomeo@istitutotumori.mi.it

 

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

Riferimento: Dr.ssa Elena Mazza
Telefono: 0226436529
Email: mazza.elena@hsr.it

 

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

Riferimento: Prof. Armando Santoro
Telefono: 0282244080
Email: armando.santoro@cancercenter.humanitas.it

 

A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO
N.B.: Arruolamento pazienti non ancora attivo

 

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

 

Centro Italia

AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI

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

 

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

Riferimento: Prof. Giampaolo Tortora
Telefono: 0630155202
Email: oncomedsperimentali@policlinicogemelli.it

 

Sud Italia e isole

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

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2020-001911-26

Data di inserimento: 12.05.2022

Promotore

Merck Sharp & Dohme LLC

CRO

NA

Principal Investigator ITALIA

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Riferimento: Prof. Giampaolo Tortora

Telefono: 0630155202

Email: oncomedsperimentali@policlinicogemelli.it

Localita: Roma

 

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