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Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to treat esophageal squamous cell carcinoma (ESCC). ESCC is a type of cancer that starts in certain cells that line the esophagus. The esophagus is the tube that connects the throat to the stomach. This study will look at ESCC that is either locally advanced unresectable, which means it has spread into tissue near where it started and cannot be completely removed by surgery, or metastatic, which means it has spread to other body parts. Available treatments for these types of ESCC include pembrolizumab and chemotherapy. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing. Researchers want to learn about giving pembrolizumab and investigational agents, with or without chemotherapy to treat ESCC. Ifinatamab deruxtecan (I-DXd), is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The main goal of this study is to learn about the safety of investigational agents and pembrolizumab with or without chemotherapy and if people tolerate them. Researchers also want to learn how cancer responds (gets smaller or goes away) to the study treatments.
Official title: A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
298
Start Date
2025-07-30
Completion Date
2032-01-04
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab
IV infusion
I-DXd
IV infusion
Leucovorin
IV infusion
Levoleucovorin
IV infusion
5-Fluorouracil (5-FU)
IV Infusion
Oxaliplatin
IV infusion
Sacituzumab tirumotecan
IV infusion
Rescue Medication
Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid for Arms 2, 3, and 4, and H1 receptor antagonist, H2 receptor antagonist, acetaminophen, and dexamethasone for Arm 5, administered per approved product label
Locations (42)
UPMC Hillman Cancer Center ( Site 1904)
Pittsburgh, Pennsylvania, United States
Liga Norte Riograndense Contra o Cancer ( Site 1301)
Natal, Rio Grande do Norte, Brazil
Hospital Nossa Senhora da Conceicao ( Site 1300)
Porto Alegre, Rio Grande do Sul, Brazil
Clínica Puerto Montt ( Site 1406)
Port Montt, Los Lagos Region, Chile
FALP ( Site 1400)
Santiago, Region M. de Santiago, Chile
Centro de Oncología de Precisión ( Site 1402)
Santiago, Region M. de Santiago, Chile
Clínica UC San Carlos de Apoquindo ( Site 1403)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 1401)
Santiago, Region M. de Santiago, Chile
Bradford Hill Norte ( Site 1405)
Antofagasta, Chile
The Second Affiliated Hospital of Anhui Medical University ( Site 9511)
Hefei, Anhui, China
Beijing Cancer Hospital ( Site 9500)
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University ( Site 9503)
Xiamen, Fujian, China
Henan Cancer Hospital ( Site 9509)
Zhengzhou, Henan, China
Xuzhou Central Hospital ( Site 9512)
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University ( Site 9505)
Nanchang, Jiangxi, China
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 9000)
Brno, Brno-mesto, Czechia
C.H.R.U. de Brest - Hopital Cavale Blanche ( Site 9104)
Brest, Finistere, France
CHU Lille - Institut Coeur Poumon ( Site 9100)
Lille, Nord, France
Pitie Salpetriere University Hospital ( Site 9102)
Paris, France
Universitätsklinikum Carl Gustav Carus - Medical Oncology ( Site 1806)
Dresden, Saxony, Germany
Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 1807)
Hamburg, Germany
Ospedale San Raffaele-Oncologia Medica ( Site 9201)
Milan, Lombardy, Italy
Istituto Oncologico Veneto IRCCS ( Site 9202)
Padova, Veneto, Italy
Aichi Cancer Center ( Site 9702)
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 9701)
Kashiwa, Chiba, Japan
National Cancer Center Hospital ( Site 9700)
Chūō, Tokyo, Japan
Oslo Universitetssykehus Radiumhospitalet ( Site 1501)
Oslo, Norway
National University Hospital ( Site 9800)
Singapore, Central Singapore, Singapore
National Cancer Center ( Site 9902)
Goyang-si, Kyonggi-do, South Korea
Asan Medical Center ( Site 9901)
Seoul, South Korea
Samsung Medical Center ( Site 9900)
Seoul, South Korea
Kantonsspital Graubuenden ( Site 1700)
Chur, Kanton Graubünden, Switzerland
Hopitaux Universitaires de Geneve HUG. ( Site 1701)
Geneva, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 1009)
Kaoshiung, Kaohsiung, Taiwan
Kaohsiung Chang Gung Memorial Hospital ( Site 1003)
Kaohsiung City, Taiwan
China Medical University Hospital ( Site 1007)
Taichung, Taiwan
National Cheng Kung University Hospital ( Site 1001)
Tainan, Taiwan
National Taiwan University Hospital ( Site 1000)
Taipei, Taiwan
Taipei Veterans General Hospital ( Site 1005)
Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou Branch ( Site 1006)
Taoyuan District, Taiwan
Ramathibodi Hospital ( Site 1103)
Ratchathewi, Bangkok, Thailand
Songklanagarind hospital ( Site 1101)
Hat Yai, Changwat Songkhla, Thailand