Actively Recruiting
Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
Led by Merck Sharp & Dohme LLC · Updated on 2026-03-31
298
Participants Needed
42
Research Sites
335 weeks
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced unresectable or metastatic squamous cell carcinoma of the esophagus in first-line treatment setting
- Measurable disease per RECIST 1.1 criteria, including lesions in previously irradiated areas if progression is shown
- Adverse events from prior anticancer therapies are Grade 1 or baseline, except alopecia and vitiligo; endocrine-related adverse events controlled with hormone replacement are allowed
- HIV-infected participants must have well-controlled HIV on antiretroviral therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate organ function
You will not qualify if you...
- Prior systemic anticancer therapy for locally advanced unresectable or metastatic esophageal cancer
- Tumor invasion into adjacent organs with increased risk of fistula (e.g., aorta or respiratory tract)
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or intervention
- Clinically significant corneal disease or severe dry eye conditions preventing or delaying corneal healing
- HIV-infected participants with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or other immune checkpoint agents
- Prior systemic anticancer therapy including investigational agents within 4 weeks before study treatment
- Prior radiotherapy within 2 weeks before study treatment or radiation-related toxicities requiring corticosteroids
- Live or live-attenuated vaccine within 30 days before study treatment; killed vaccines allowed
- Inadequate cardiac function (QTcF >470 msec)
- Clinically significant cardiovascular disease within 6 months before study treatment
- Peripheral neuropathy Grade 2 or higher
- Immunodeficiency or chronic systemic steroid or other immunosuppressive therapy within 7 days before study treatment
- Known additional malignancy progressing or treated within past 3 years
- Active central nervous system metastases or carcinomatous meningitis
- Active autoimmune disease requiring systemic treatment in past 2 years
- Pneumonitis or interstitial lung disease requiring steroids or suspected but unconfirmed by imaging
- Active infection requiring systemic therapy
- Severe pulmonary compromise from other lung illnesses
AI-Screening
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Trial Site Locations
Total: 42 locations
1
UPMC Hillman Cancer Center ( Site 1904)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
2
Liga Norte Riograndense Contra o Cancer ( Site 1301)
Natal, Rio Grande do Norte, Brazil, 59062-000
Actively Recruiting
3
Hospital Nossa Senhora da Conceicao ( Site 1300)
Porto Alegre, Rio Grande do Sul, Brazil, 91010-004
Actively Recruiting
4
Clínica Puerto Montt ( Site 1406)
Port Montt, Los Lagos Region, Chile, 5500243
Actively Recruiting
5
FALP ( Site 1400)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
6
Centro de Oncología de Precisión ( Site 1402)
Santiago, Region M. de Santiago, Chile, 7560908
Actively Recruiting
7
Clínica UC San Carlos de Apoquindo ( Site 1403)
Santiago, Region M. de Santiago, Chile, 7620002
Actively Recruiting
8
Bradfordhill ( Site 1401)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
9
Bradford Hill Norte ( Site 1405)
Antofagasta, Chile, 1263521
Actively Recruiting
10
The Second Affiliated Hospital of Anhui Medical University ( Site 9511)
Hefei, Anhui, China, 230601
Actively Recruiting
11
Beijing Cancer Hospital ( Site 9500)
Beijing, Beijing Municipality, China, 130021
Actively Recruiting
12
The First Affiliated Hospital of Xiamen University ( Site 9503)
Xiamen, Fujian, China, 361003
Actively Recruiting
13
Henan Cancer Hospital ( Site 9509)
Zhengzhou, Henan, China, 450008
Actively Recruiting
14
Xuzhou Central Hospital ( Site 9512)
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
15
The First Affiliated Hospital of Nanchang University ( Site 9505)
Nanchang, Jiangxi, China, 330006
Actively Recruiting
16
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 9000)
Brno, Brno-mesto, Czechia, 656 53
Actively Recruiting
17
C.H.R.U. de Brest - Hopital Cavale Blanche ( Site 9104)
Brest, Finistere, France, 29609
Actively Recruiting
18
CHU Lille - Institut Coeur Poumon ( Site 9100)
Lille, Nord, France, 59037
Actively Recruiting
19
Pitie Salpetriere University Hospital ( Site 9102)
Paris, France, 75013
Actively Recruiting
20
Universitätsklinikum Carl Gustav Carus - Medical Oncology ( Site 1806)
Dresden, Saxony, Germany, 01307
Actively Recruiting
21
Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 1807)
Hamburg, Germany, 20249
Actively Recruiting
22
Ospedale San Raffaele-Oncologia Medica ( Site 9201)
Milan, Lombardy, Italy, 20132
Actively Recruiting
23
Istituto Oncologico Veneto IRCCS ( Site 9202)
Padova, Veneto, Italy, 35128
Actively Recruiting
24
Aichi Cancer Center ( Site 9702)
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
25
National Cancer Center Hospital East ( Site 9701)
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
26
National Cancer Center Hospital ( Site 9700)
Chūō, Tokyo, Japan, 104-0045
Actively Recruiting
27
Oslo Universitetssykehus Radiumhospitalet ( Site 1501)
Oslo, Norway, 0379
Actively Recruiting
28
National University Hospital ( Site 9800)
Singapore, Central Singapore, Singapore, 119074
Actively Recruiting
29
National Cancer Center ( Site 9902)
Goyang-si, Kyonggi-do, South Korea, 10408
Actively Recruiting
30
Asan Medical Center ( Site 9901)
Seoul, South Korea, 05505
Actively Recruiting
31
Samsung Medical Center ( Site 9900)
Seoul, South Korea, 06351
Actively Recruiting
32
Kantonsspital Graubuenden ( Site 1700)
Chur, Kanton Graubünden, Switzerland, 7000
Actively Recruiting
33
Hopitaux Universitaires de Geneve HUG. ( Site 1701)
Geneva, Switzerland, 1211
Actively Recruiting
34
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 1009)
Kaoshiung, Kaohsiung, Taiwan, 807
Actively Recruiting
35
Kaohsiung Chang Gung Memorial Hospital ( Site 1003)
Kaohsiung City, Taiwan, 83301
Actively Recruiting
36
China Medical University Hospital ( Site 1007)
Taichung, Taiwan, 40707
Actively Recruiting
37
National Cheng Kung University Hospital ( Site 1001)
Tainan, Taiwan, 704
Actively Recruiting
38
National Taiwan University Hospital ( Site 1000)
Taipei, Taiwan, 100225
Actively Recruiting
39
Taipei Veterans General Hospital ( Site 1005)
Taipei, Taiwan, 11217
Actively Recruiting
40
Chang Gung Memorial Hospital - Linkou Branch ( Site 1006)
Taoyuan, Taiwan, 33305
Actively Recruiting
41
Ramathibodi Hospital ( Site 1103)
Ratchathewi, Bangkok, Thailand, 10400
Actively Recruiting
42
Songklanagarind hospital ( Site 1101)
Hat Yai, Changwat Songkhla, Thailand, 90110
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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