A Study to Evaluate 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
Esophageal Squamous Cell Carcinoma
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma 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, 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.
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.
- 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.
- Gastrointestinal (GI) obstruction, poor oral intake, or difficulty in taking oral medication.
- 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 4303)Recruiting
- Hospital Nossa Senhora da Conceição ( Site 4301)Recruiting
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 4300)Recruiting
- FALP-UIDO ( Site 4400)Recruiting
- Clínica las Condes ( Site 4403)Recruiting
- Anhui Provincil Hospital South District ( Site 3501)Recruiting
- Beijing Cancer hospital-Digestive Oncology ( Site 3500)Recruiting
- The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 3510)Recruiting
- First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 3506)Recruiting
- Shanghai Chest Hospital-Esophageal surgery department ( Site 3513)Recruiting
- Zhejiang Cancer Hospital-Thoracic oncology ( Site 3511)Recruiting
- Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 4801)Recruiting
- Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 4804)Recruiting
- Ospedale San Raffaele-Oncologia Medica ( Site 3202)Recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3200)Recruiting
- Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (Recruiting
- Aichi Cancer Center Hospital ( Site 3702)Recruiting
- National Cancer Center Hospital East ( Site 3701)Recruiting
- Saitama Prefectural Cancer Center ( Site 3703)Recruiting
- Shizuoka Cancer Center ( Site 3704)Recruiting
- National Cancer Center Hospital ( Site 3700)Recruiting
- Asan Medical Center-Department of Oncology ( Site 3901)Recruiting
- Samsung Medical Center-Division of Hematology/Oncology ( Site 3900)Recruiting
- Oslo universitetssykehus, Radiumhospitalet ( Site 4501)Recruiting
- National University Hospital ( Site 3800)Recruiting
- Hôpitaux Universitaires de Genève (HUG) ( Site 4702)Recruiting
- Kantonsspital Graubünden-Medizin ( Site 4700)Recruiting
- Chang Gung Memorial Hospital at Kaohsiung ( Site 4003)Recruiting
- China Medical University Hospital ( Site 4007)Recruiting
- Taichung Veterans General Hospital-Radiation Oncology ( Site 4008)Recruiting
- National Cheng Kung University Hospital ( Site 4001)Recruiting
- National Taiwan University Hospital ( Site 4000)Recruiting
- Taipei Veterans General Hospital ( Site 4005)Recruiting
- Chang Gung Medical Foundation-Linkou Branch ( Site 4006)Recruiting
- Faculty of Medicine Siriraj Hospital ( Site 4102)Recruiting
- Hacettepe Universite Hastaneleri-oncology hospital ( Site 3402)Recruiting
- Ankara Bilkent City Hospital-Medical Oncology ( Site 3405)Recruiting
- Atatürk Üniversitesi-onkoloji ( Site 3416)Recruiting
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3403)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Paclitaxel or irinotecan
Pembrolizumab + MK-4830 + paclitaxel or irinotecan
Pembrolizumab + MK-4830 + lenvatinib
Participants receive paclitaxel 80-100 mg/m^2 intravenously (IV) on days 1, 8, and 15 every 28-day cycle until progressive disease (PD) or discontinuation, or irinotecan 180 mg/m^2 IV on day 1 of every 14-day cycle until PD or discontinuation.
Participants receive pembrolizumab 200 mg IV once every 3 weeks (Q3W) for up to 35 cycles (cycle=21 days) or until PD or discontinuation + MK-4830 800 mg IV Q3W up to 35 infusions + paclitaxel 80-100 mg/m^2 IV on days 1, 8, and 15 every 28-day cycle until PD or discontinuation or irinotecan 180 mg/m^2 180 mg/m^2 on day 1 every 14-day cycle until PD or discontinuation.
Participants receive pembrolizumab 200 mg IV Q3W up to 35 cycles (cycle=21 days) until PD or discontinuation + MK-4830 800 mg IV Q3W up to 35 infusions + lenvatinib 20 mg oral administration every day until PD or discontinuation.