Study of Combination Therapies in Esophageal Cancer
- Conditions
- Advanced esophageal squamous cell carcinomaMedDRA version: 25.1Level: LLTClassification code: 10030186Term: Oesophageal squamous cell carcinoma NOS Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-505189-26-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable esophageal squamous cell carcinoma (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-programmed cell death 1 (PD1)/programmed cell death ligand 1 (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 (AE) 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., 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 gastrointestinal (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), 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method