RecruitingPhase I/IIEN original

Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzony rak płaskonabłonkowy przełyku, który jest zaawansowany i nie można go usunąć operacyjnie, lub który rozprzestrzenił się na inne części ciała, i jest to pierwszy etap leczenia.
  • Rak przełyku, który można zmierzyć za pomocą badań obrazowych.
  • Dolegliwości uboczne po wcześniejszym leczeniu raka ustąpiły lub są łagodne.
  • Osoby zakażone wirusem HIV muszą mieć dobrze kontrolowane wirusy dzięki leczeniu.
  • Ogólny stan zdrowia pozwala na aktywność (skala 0-1).
  • Narządy wewnętrzne działają prawidłowo.

✗ Disqualifies

  • Osoby, które już przyjmowały inne leki przeciwnowotworowe w leczeniu tego rodzaju raka przełyku.
  • Rak naciekający na sąsiednie narządy, co zwiększa ryzyko powstania przetoki.
  • Płyn w jamie opłucnej, osierdziu lub brzuchu, który wymaga częstego odprowadzania.
  • Ciężkie choroby oczu lub suchość oka, które mogą utrudniać gojenie się rogówki.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
June 29, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (43)

UPMC Hillman Cancer Center ( Site 1904)

Pittsburgh, United States

Liga Norte Riograndense Contra o Cancer ( Site 1301)

Natal, Brazil

Hospital Nossa Senhora da Conceicao ( Site 1300)

Porto Alegre, Brazil

Clínica Puerto Montt ( Site 1406)

Port Montt, Chile

FALP ( Site 1400)

Santiago, Chile

Centro de Oncología de Precisión ( Site 1402)

Santiago, Chile

Clínica UC San Carlos de Apoquindo ( Site 1403)

Santiago, Chile

Bradfordhill ( Site 1401)

Santiago, Chile

Bradford Hill Norte ( Site 1405)

Antofagasta, Chile

The Second Affiliated Hospital of Anhui Medical University ( Site 9511)

Hefei, China

Beijing Cancer Hospital ( Site 9500)

Beijing, China

The First Affiliated Hospital of Xiamen University ( Site 9503)

Xiamen, China

Henan Cancer Hospital ( Site 9509)

Zhengzhou, China

Xuzhou Central Hospital ( Site 9512)

Xuzhou, China

The First Affiliated Hospital of Nanchang University ( Site 9505)

Nanchang, China

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 9000)

Brno, Czechia

C.H.R.U. de Brest - Hopital Cavale Blanche ( Site 9104)

Brest, France

CHU Lille - Institut Coeur Poumon ( Site 9100)

Lille, France

Pitie Salpetriere University Hospital ( Site 9102)

Paris, France

Universitaetsklinikum Duesseldorf ( Site 1808)

Düsseldorf, Germany

Universitätsklinikum Carl Gustav Carus - Medical Oncology ( Site 1806)

Dresden, Germany

Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 1807)

Hamburg, Germany

Ospedale San Raffaele-Oncologia Medica ( Site 9201)

Milan, Italy

Istituto Oncologico Veneto IRCCS ( Site 9202)

Padova, Italy

Aichi Cancer Center ( Site 9702)

Nagoya, Japan

National Cancer Center Hospital East ( Site 9701)

Kashiwa, Japan

National Cancer Center Hospital ( Site 9700)

Chūō, Japan

Oslo Universitetssykehus Radiumhospitalet ( Site 1501)

Oslo, Norway

National University Hospital ( Site 9800)

Singapore, Singapore

National Cancer Center ( Site 9902)

Goyang-si, South Korea

Asan Medical Center ( Site 9901)

Seoul, South Korea

Samsung Medical Center ( Site 9900)

Seoul, South Korea

Kantonsspital Graubuenden ( Site 1700)

Chur, Switzerland

Hopitaux Universitaires de Geneve HUG. ( Site 1701)

Geneva, Switzerland

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 1009)

Kaoshiung, 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, Taiwan

Ramathibodi Hospital ( Site 1103)

Ratchathewi, Thailand

Songklanagarind hospital ( Site 1101)

Hat Yai, Thailand

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.