Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
Start Date
7/30/2025
Completion Date
1/4/2032
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.
Detailed Description
The master protocol is MK-3475-U06.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Pembrolizumab
I-DXd
Leucovorin
Levoleucovorin
5-Fluorouracil (5-FU)
Oxaliplatin
Sacituzumab tirumotecan
Rescue Medication
Conditions
Locations
UPMC Hillman Cancer Center ( Site 1904)
Pittsburgh, Pennsylvania 15232
United States
Liga Norte Riograndense Contra o Cancer ( Site 1301)
Natal, Rio Grande do Norte 59062-000
Brazil
Hospital Nossa Senhora da Conceicao ( Site 1300)
Porto Alegre, Rio Grande do Sul 91010-004
Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1302)
São Paulo, 01246-000
Brazil
Clínica Puerto Montt ( Site 1406)
Port Montt, Los Lagos Region 5500243
Chile
FALP ( Site 1400)
Santiago, Region M. de Santiago 7500921
Chile
Centro de Oncología de Precisión ( Site 1402)
Santiago, Region M. de Santiago 7560908
Chile
Clínica UC San Carlos de Apoquindo ( Site 1403)
Santiago, Region M. de Santiago 7620002
Chile
Bradfordhill ( Site 1401)
Santiago, Region M. de Santiago 8420383
Chile
Bradford Hill Norte ( Site 1405)
Antofagasta, 1263521
Chile
The Second Affiliated Hospital of Anhui Medical University ( Site 9511)
Hefei, Anhui 230601
China
Beijing Cancer Hospital ( Site 9500)
Beijing, Beijing Municipality 130021
China
The First Affiliated Hospital of Xiamen University ( Site 9503)
Xiamen, Fujian 361003
China
Henan Cancer Hospital ( Site 9509)
Zhengzhou, Henan 450008
China
Xuzhou Central Hospital ( Site 9512)
Xuzhou, Jiangsu 221000
China
The First Affiliated Hospital of Nanchang University ( Site 9505)
Nanchang, Jiangxi 330006
China
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 9000)
Brno, Brno-mesto 656 53
Czechia
C.H.R.U. de Brest - Hopital Cavale Blanche ( Site 9104)
Brest, Finistere 29609
France
CHU Lille - Institut Coeur Poumon ( Site 9100)
Lille, Nord 59037
France
Pitie Salpetriere University Hospital ( Site 9102)
Paris, 75013
France
Universitaetsklinikum Duesseldorf ( Site 1808)
Düsseldorf, North Rhine-Westphalia 40225
Germany
Universitätsklinikum Carl Gustav Carus - Medical Oncology ( Site 1806)
Dresden, Saxony 01307
Germany
Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 1807)
Hamburg, 20249
Germany
Ospedale San Raffaele-Oncologia Medica ( Site 9201)
Milan, Lombardy 20132
Italy
Istituto Oncologico Veneto IRCCS ( Site 9202)
Padova, Veneto 35128
Italy
Aichi Cancer Center ( Site 9702)
Nagoya, Aichi-ken 464-8681
Japan
National Cancer Center Hospital East ( Site 9701)
Kashiwa, Chiba 277-8577
Japan
National Cancer Center Hospital ( Site 9700)
Chūō, Tokyo 104-0045
Japan
Oslo Universitetssykehus Radiumhospitalet ( Site 1501)
Oslo, 0379
Norway
National University Hospital ( Site 9800)
Singapore, Central Singapore 119074
Singapore
National Cancer Center ( Site 9902)
Goyang-si, Kyonggi-do 10408
South Korea
Asan Medical Center ( Site 9901)
Seoul, 05505
South Korea
Samsung Medical Center ( Site 9900)
Seoul, 06351
South Korea
Kantonsspital Graubuenden ( Site 1700)
Chur, Kanton Graubünden 7000
Switzerland
Hopitaux Universitaires de Geneve HUG. ( Site 1701)
Geneva, 1211
Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 1009)
Kaoshiung, Kaohsiung 807
Taiwan
Kaohsiung Chang Gung Memorial Hospital ( Site 1003)
Kaohsiung City, 83301
Taiwan
China Medical University Hospital ( Site 1007)
Taichung, 40707
Taiwan
National Cheng Kung University Hospital ( Site 1001)
Tainan, 704
Taiwan
National Taiwan University Hospital ( Site 1000)
Taipei, 100225
Taiwan
Taipei Veterans General Hospital ( Site 1005)
Taipei, 11217
Taiwan
Chang Gung Memorial Hospital - Linkou Branch ( Site 1006)
Taoyuan, 33305
Taiwan
Ramathibodi Hospital ( Site 1103)
Ratchathewi, Bangkok 10400
Thailand
Songklanagarind hospital ( Site 1101)
Hat Yai, Changwat Songkhla 90110
Thailand