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MK-3475-06A - A Study of Combination Therapies With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer (MK-3475-06A)

Studio Clinico

Patologia: Tumori dell’esofago

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico


Fase di studio: 1, II

Richiesta mandatoria di tessuto: 

Linee di trattamento: Seconda linea

Criteri di inclusione: 

- Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable ESCC.
- Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy.
- Has an evaluable baseline tumor sample (newly obtained or archival) for analysis.
- Has adequately controlled blood pressure (BP) with or without antihypertensive medications.
- Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline.
- Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.

Criteri di esclusione: 

- Direct invasion into adjacent organs such as the aorta or trachea.
- Has experienced weight loss >10% over approximately 2 months prior to first dose of study therapy.
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative therapy. - Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Active autoimmune disease that has required systemic treatment in past 2 years.
- History of human immunodeficiency virus (HIV) infection.
- History of Hepatitis B or known active Hepatitis C virus infection.
- History of allogenic tissue/solid organ transplant.
- Clinically significant cardiovascular disease within 12 months from first dose of study intervention.
- Participants with known gastrointestinal (GI) malabsorption or any other condition that may affect the absorption of Lenvatinib.
- Has risk for significant GI bleeding, such as:
- Has had a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization.
- Has significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization.

Trattamento sperimentale: 

BIOLOGICAL: Pembrolizumab
BIOLOGICAL: Coformulation favezelimab/pembrolizumab
DRUG: Lenvatinib
DRUG: Irinotecan
DRUG: Paclitaxel

Trattamento di controllo: 


Centri partecipanti

Nord Italia

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

Riferimento: Dr. Filippo Pietrantonio
Telefono: 0223903822


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

Riferimento: Dr.ssa Elena Mazza
Telefono: 0226437627


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

Riferimento: Dr.ssa Sara Lonardi

Informazioni Generali


Numero di iscrizione a registro: 2021-005405-26

Data di inserimento: 07.11.2023

Data di aggiornamento: 27.06.2024


Merck Sharp & Dohme LLC



Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000


Localita: Milano


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