Last updated 31 days ago
A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)
200 patients around the world
Available in Brazil, Chile
The master protocol is MK-3475-U06.
As of Protocol Amendment 5, the Pembrolizumab Plus MK-4830 Plus Paclitaxel/Irinotecan arm
and the Pembrolizumab Plus MK-4830 Plus Lenvatinib arm are no longer actively enrolling
participants.
Merck Sharp & Dohme LLC
5Research sites
200Patients around the world
This study is for people with
Esophageal cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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, that includes a platinum agent and previous exposure to an anti-PD1/PD-L1 based 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.
- 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 history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.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.Known GI malabsorption or any other condition that may affect the absorption of lenvatinib. (Not applicable to actively enrolling arms as of Amendment 5)Has risk for significant GI bleeding such as a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization, significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization. (Not applicable to actively enrolling arms as of Amendment 5)
Sites
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica
Recruiting
Hospital Nossa Senhora da Conceição
Recruiting
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
Recruiting
Clínica Las Condes - Santiago de Chile
Recruiting
Instituto Oncológico FALP - UIDO
Recruiting
SponsorMerck Sharp & Dohme LLC
Conditions
Esophageal cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05319730
