A Study of Combination Therapies With Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer (MK-3475-06A)
Esophageal Squamous Cell Carcinoma (ESCC)
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma (ESCC) focused on measuring Esophageal cancer, Programmed Cell Death 1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL-1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL-2, PD-L2)
Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Liga Norte Riograndense Contra o Câncer ( Site 2303)Recruiting
- Hospital Nossa Senhora da Conceição ( Site 2301)Recruiting
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 2300)Recruiting
- FALP-UIDO ( Site 2400)Recruiting
- Clínica las Condes ( Site 2403)Recruiting
- Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan ( Site 1104)Recruiting
- Hopital Claude Huriez - CHU de Lille ( Site 1100)Recruiting
- Pitie Salpetriere University Hospital ( Site 1102)Recruiting
- Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 2801)Recruiting
- Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 2804)Recruiting
- Ospedale San Raffaele-Oncologia Medica ( Site 1206)Recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1200)Recruiting
- Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (Recruiting
- Aichi Cancer Center Hospital ( Site 1702)Recruiting
- National Cancer Center Hospital East ( Site 1701)Recruiting
- Saitama Prefectural Cancer Center ( Site 1703)Recruiting
- Shizuoka Cancer Center ( Site 1704)Recruiting
- National Cancer Center Hospital ( Site 1700)Recruiting
- Asan Medical Center-Department of Oncology ( Site 1901)Recruiting
- Samsung Medical Center-Division of Hematology/Oncology ( Site 1900)Recruiting
- Oslo universitetssykehus, Radiumhospitalet ( Site 2501)Recruiting
- National University Hospital ( Site 1800)Recruiting
- Hôpitaux Universitaires de Genève (HUG) ( Site 2702)Recruiting
- Kantonsspital Graubünden-Medizin ( Site 2700)Recruiting
- Chang Gung Memorial Hospital at Kaohsiung ( Site 2003)Recruiting
- China Medical University Hospital ( Site 2007)Recruiting
- Taichung Veterans General Hospital-Radiation Oncology ( Site 2008)Recruiting
- National Cheng Kung University Hospital ( Site 2001)Recruiting
- National Taiwan University Hospital ( Site 2000)Recruiting
- Taipei Veterans General Hospital ( Site 2005)Recruiting
- Chang Gung Medical Foundation-Linkou Branch ( Site 2006)Recruiting
- Chulalongkorn University ( Site 2104)Recruiting
- Faculty of Medicine Siriraj Hospital ( Site 2102)Recruiting
- Songklanagarind hospital ( Site 2105)Recruiting
- I.E.U. Medical Point Hastanesi-Oncology ( Site 1406)Recruiting
- Hacettepe Universite Hastaneleri-oncology hospital ( Site 1402)Recruiting
- Ankara City Hospital-Medical Oncology ( Site 1405)Recruiting
- Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1410)Recruiting
- Atatürk Üniversitesi-onkoloji ( Site 1416)Recruiting
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1403)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Pembrolizumab plus chemotherapy
Coformulation Favezelimab/Pembrolizumab plus Chemotherapy
Pembrolizumab plus MK-4380 plus Chemotherapy
Pembrolizumab plus MK-4380 plus lenvatinib
Participants will receive pembrolizumab intravenously plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Participants will receive coformulation of favezelimab/pembrolizumab administered intravenously plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Participants will receive pembrolizumab intravenously plus MK-4380 plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Participants will receive pembrolizumab intravenously plus MK-4380 plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.