Patologia: Tumori dell’esofago
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: No
Fase di studio: 1, II
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.
- 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:
Pembrolizumab; Coformulation favezelimab/pembrolizumab; MK-4830; Lenvatinib; Irinotecan; Paclitaxel
Trattamento di controllo:
NA
IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
SC Oncologia Medica 1
Riferimento: Dr.ssa Maria Di Bartolomeo
Telefono: 0223903066
Email: maria.dibartolomeo@istitutotumori.mi.it
Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative
Riferimento: Prof. Giuseppe Curigliano
Telefono: 0257489599
Email: giuseppe.curigliano@ieo.it
Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
Oncologia Medica
Riferimento: Dr.ssa Elena Mazza
Telefono: 0226437627
Email: oncologia.medica@hsr.it
Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
NB: Arruolamento pazienti non ancora attivo
Riferimento: Dr.ssa Sara Lonardi
Email: sara.lonardi@iov.veneto.it
Numero di iscrizione a registro: 2021-005405-26
Data di inserimento: 07.11.2023
Merck Sharp & Dohme LLC
NA
IEO - Istituto Europeo di Oncologia, Milano
Riferimento: Prof. Giuseppe Curigliano
Telefono: 0257489599
Email: giuseppe.curigliano@ieo.it
Localita: Milano