Actively Recruiting
A Study to Evaluate Investigational Agents With or Without 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 (MK-3475-06B)
Led by Merck Sharp & Dohme LLC · Updated on 2026-03-20
230
Participants Needed
57
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study to evaluate the safety and efficacy of investigational agents with or without pembrolizumab and/or chemotherapy, for the treatment of participants with second line (2L) esophageal squamous cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 based treatment.
CONDITIONS
Official Title
A Study to Evaluate Investigational Agents With or Without 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 (MK-3475-06B)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with histologically or cytologically confirmed metastatic or locally advanced unresectable esophageal squamous cell carcinoma
- Disease progression after one prior standard therapy including a platinum agent and prior PD-1/PD-L1 immune therapy
- Availability of archival or recent tumor tissue sample
- Recovery to grade 1 or baseline from prior treatment adverse events, with endocrine AEs controlled by hormone replacement or neuropathy grade ≤2
You will not qualify if you...
- Direct invasion into adjacent organs like aorta or trachea
- Weight loss over 10% in about 2 months before first study dose
- History of severe dry eye syndrome, Meibomian gland disease, blepharitis, or severe corneal disease delaying healing
- Active or history of inflammatory bowel disease requiring immunosuppressive medication
- Receipt of investigational agent or device within 4 weeks before study treatment
- Known progressing additional malignancy requiring treatment within past 3 years except certain skin cancers
- Active central nervous system metastases or carcinomatous meningitis
- HIV with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- History of allogenic tissue or solid organ transplant
- Significant cardiovascular disease within 12 months before study intervention
- Risk of significant gastrointestinal bleeding or recent serious bleeding events
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 57 locations
1
University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927)
Tucson, Arizona, United States, 85719
Actively Recruiting
2
UCLA Hematology/Oncology - Santa Monica ( Site 4905)
Los Angeles, California, United States, 90404
Actively Recruiting
3
Hematology-Oncology Associates of Central NY, P.C. ( Site 4925)
East Syracuse, New York, United States, 13057
Actively Recruiting
4
Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 4907)
New York, New York, United States, 10032
Completed
5
UPMC Hillman Cancer Center-UPMC ( Site 4904)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
6
Liga Norte Riograndense Contra o Câncer ( Site 4303)
Natal, Rio Grande do Norte, Brazil, 59062-000
Actively Recruiting
7
Hospital Nossa Senhora da Conceição ( Site 4301)
Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
Actively Recruiting
8
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 4300)
São Paulo, Brazil, 01246-000
Actively Recruiting
9
FALP-UIDO ( Site 4400)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
10
Centro de Oncología de Precisión-Oncology ( Site 4404)
Santiago, Region M. de Santiago, Chile, 7560908
Actively Recruiting
11
Clínica las Condes ( Site 4403)
Santiago, Region M. de Santiago, Chile, 7591047
Actively Recruiting
12
Clínica UC San Carlos de Apoquindo ( Site 4405)
Santiago, Region M. de Santiago, Chile, 7620002
Actively Recruiting
13
Anhui Provincial Hospital South District ( Site 3501)
Hefei, Anhui, China, 230036
Actively Recruiting
14
Beijing Cancer hospital-Digestive Oncology ( Site 3500)
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
15
The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 3510)
Xinxiang, Henan, China, 453100
Actively Recruiting
16
First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 3506)
Huai'an, Jiangsu, China, 223300
Actively Recruiting
17
Shanghai Chest Hospital-Esophageal surgery department ( Site 3513)
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
18
Zhejiang Cancer Hospital-Thoracic oncology ( Site 3511)
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
19
Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 4801)
Frankfurt am Main, Hesse, Germany, 60488
Completed
20
Universitaetsklinikum Duesseldorf ( Site 4802)
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Completed
21
Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 4806)
Dresden, Saxony, Germany, 01307
Actively Recruiting
22
Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 4804)
Berlin, Germany, 13353
Completed
23
Facharztzentrum Eppendorf ( Site 4807)
Hamburg, Germany, 20249
Actively Recruiting
24
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 3207)
Meldola, Emilia-Romagna, Italy, 47014
Actively Recruiting
25
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3200)
Milan, Lombardy, Italy, 20133
Actively Recruiting
26
Azienda Ospedaliero Universitaria Pisana ( Site 3206)
Pisa, Tuscany, Italy, 56126
Actively Recruiting
27
Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 3203)
Padova, Veneto, Italy, 35128
Actively Recruiting
28
Ospedale San Raffaele-Oncologia Medica ( Site 3202)
Milan, Italy, 20132
Actively Recruiting
29
Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative ( Site 3201)
Milan, Italy, 20141
Completed
30
Aichi Cancer Center ( Site 3702)
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
31
National Cancer Center Hospital East ( Site 3701)
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
32
Saitama Prefectural Cancer Center ( Site 3703)
Kitaadachi-gun, Saitama, Japan, 3620806
Actively Recruiting
33
Shizuoka Cancer Center ( Site 3704)
Nagaizumi-cho,Sunto-gun, Shizuoka, Japan, 411-8777
Actively Recruiting
34
National Cancer Center Hospital ( Site 3700)
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
35
Oslo universitetssykehus, Radiumhospitalet ( Site 4501)
Oslo, Norway, 0379
Actively Recruiting
36
National University Hospital ( Site 3800)
Singapore, South West, Singapore, 119074
Actively Recruiting
37
Asan Medical Center-Department of Oncology ( Site 3901)
Seoul, South Korea, 05505
Actively Recruiting
38
Samsung Medical Center-Division of Hematology/Oncology ( Site 3900)
Seoul, South Korea, 06351
Actively Recruiting
39
Hôpitaux Universitaires de Genève (HUG) ( Site 4702)
Geneva, Canton of Geneva, Switzerland, 1211
Actively Recruiting
40
Kantonsspital Graubünden-Medizin ( Site 4700)
Chur, Kanton Graubünden, Switzerland, 7000
Actively Recruiting
41
Chang Gung Memorial Hospital at Kaohsiung ( Site 4003)
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
Actively Recruiting
42
China Medical University Hospital ( Site 4007)
Taichung, Taiwan, 404332
Actively Recruiting
43
Taichung Veterans General Hospital-Radiation Oncology ( Site 4008)
Taichung, Taiwan, 407
Actively Recruiting
44
National Cheng Kung University Hospital ( Site 4001)
Tainan, Taiwan, 704
Actively Recruiting
45
National Taiwan University Hospital ( Site 4000)
Taipei, Taiwan, 10002
Actively Recruiting
46
Taipei Veterans General Hospital ( Site 4005)
Taipei, Taiwan, 112
Actively Recruiting
47
Chang Gung Medical Foundation-Linkou Branch ( Site 4006)
Taoyuan, Taiwan, 33305
Actively Recruiting
48
Chulalongkorn University ( Site 4104)
Bangkok, Bangkok, Thailand, 10330
Actively Recruiting
49
Faculty of Medicine Siriraj Hospital ( Site 4102)
Bangkok, Bangkok, Thailand, 10700
Actively Recruiting
50
Songklanagarind hospital ( Site 4105)
Hat Yai, Changwat Songkhla, Thailand, 90110
Actively Recruiting
51
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 3417)
Adana, Turkey (Türkiye), 01140
Actively Recruiting
52
Hacettepe Universite Hastaneleri-oncology hospital ( Site 3402)
Ankara, Turkey (Türkiye), 06230
Completed
53
Memorial Ankara Hastanesi-Medical Oncology ( Site 3408)
Ankara, Turkey (Türkiye), 06520
Completed
54
Ankara Bilkent City Hospital-Medical Oncology ( Site 3405)
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
55
Atatürk Üniversitesi-onkoloji ( Site 3416)
Erzurum, Turkey (Türkiye), 25070
Actively Recruiting
56
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3403)
Istanbul, Turkey (Türkiye), 34722
Actively Recruiting
57
I.E.U. Medical Point Hastanesi-Oncology ( Site 3406)
Izmir, Turkey (Türkiye), 35575
Completed
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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