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NCT05319730RecruitingPhase 1/2

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)

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06B

Source: ClinicalTrials.gov · Last updated 7 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
230 (estimated)
First submitted
1 Apr 2022
Start date
16 May 2023
Primary completion date
11 Jun 2027
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT05319730
EU CT number
2023-505189-26-00
EudraCT number
2021-005443-76

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 230
  • From 16 May 2023 to the primary completion date, 11 Jun 2027
  • 58 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has experienced weight loss \>10% over approximately 2 months prior to first dose of study therapy
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
  • Has risk for significant gastrointestinal (GI) bleeding such as a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization, significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization

Other illness

  • Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative therapy
  • Participants with human immunodeficiency virus (HIV) with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • History of allogenic tissue/solid organ transplant
  • Clinically significant cardiovascular disease within 12 months from first dose of study intervention

Other

  • Direct invasion into adjacent organs such as the aorta or trachea
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Who the study is looking for

  • Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable esophageal squamous cell carcinoma (ESCC)
  • Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy, that includes a platinum agent and previous exposure to an anti-programmed cell death 1 (PD1)/programmed cell death ligand 1 (PD-L1) based immune oncology (IO) therapy
  • Has provided an archival or most recent tumor tissue sample obtained as part of clinical practice
  • Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible

Criteria the registry did not label

  • The main inclusion and exclusion criteria include but are not limited to the following:

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (58)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Liga Norte Riograndense Contra o Câncer ( Site 4303)
Coordinator of this site? Confirm its status
NatalBrazilRecruiting
Hospital Nossa Senhora da Conceição ( Site 4301)
Coordinator of this site? Confirm its status
Porto AlegreBrazilRecruiting
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 4300)
Coordinator of this site? Confirm its status
São PauloBrazilRecruiting
Kantonsspital Graubünden-Medizin ( Site 4700)
Coordinator of this site? Confirm its status
ChurSwitzerlandRecruiting
Hôpitaux Universitaires de Genève (HUG) ( Site 4702)
Coordinator of this site? Confirm its status
GenevaSwitzerlandRecruiting
Clínica UC San Carlos de Apoquindo ( Site 4405)
Coordinator of this site? Confirm its status
SantiagoChileRecruiting
Clínica las Condes ( Site 4403)
Coordinator of this site? Confirm its status
SantiagoChileCompleted
FALP-UIDO ( Site 4400)
Coordinator of this site? Confirm its status
SantiagoChileRecruiting
Centro de Oncología de Precisión-Oncology ( Site 4404)
Coordinator of this site? Confirm its status
SantiagoChileRecruiting
Beijing Cancer hospital-Digestive Oncology ( Site 3500)
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
Zhejiang Cancer Hospital-Thoracic oncology ( Site 3511)
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
Anhui Provincial Hospital ( Site 3501)
Coordinator of this site? Confirm its status
HefeiChinaRecruiting
First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 3506)
Coordinator of this site? Confirm its status
Huai'anChinaRecruiting
Shanghai Chest Hospital-Esophageal surgery department ( Site 3513)
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
The First Affiliated Hospital of Xiamen University ( Site 3516)
Coordinator of this site? Confirm its status
XiamenChinaRecruiting
The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 3510)
Coordinator of this site? Confirm its status
XinxiangChinaRecruiting
Henan Cancer Hospital ( Site 3518)
Coordinator of this site? Confirm its status
ZhengzhouChinaRecruiting
Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 4804)
Coordinator of this site? Confirm its status
BerlinGermanyCompleted
Universitaetsklinikum Duesseldorf ( Site 4802)
Coordinator of this site? Confirm its status
DüsseldorfGermanyCompleted
HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 4807)
Coordinator of this site? Confirm its status
ErdgeschossGermanyRecruiting
Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 4801)
Coordinator of this site? Confirm its status
Frankfurt am MainGermanyCompleted
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 3207)
Coordinator of this site? Confirm its status
MeldolaItalyRecruiting
Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative ( Site 3201)
Coordinator of this site? Confirm its status
MilanItalyCompleted
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3200)
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Ospedale San Raffaele-Oncologia Medica ( Site 3202)
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 3203)
Coordinator of this site? Confirm its status
PadovaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana ( Site 3206)
Coordinator of this site? Confirm its status
PisaItalyRecruiting
National Cancer Center Hospital ( Site 3700)
Coordinator of this site? Confirm its status
Chuo-kuJapanRecruiting
National Cancer Center Hospital East ( Site 3701)
Coordinator of this site? Confirm its status
KashiwaJapanRecruiting
Saitama Prefectural Cancer Center ( Site 3703)
Coordinator of this site? Confirm its status
Kitaadachi-gunJapanRecruiting
Shizuoka Cancer Center ( Site 3704)
Coordinator of this site? Confirm its status
Nagaizumi-cho,Sunto-gunJapanRecruiting
Aichi Cancer Center ( Site 3702)
Coordinator of this site? Confirm its status
NagoyaJapanRecruiting
Asan Medical Center-Department of Oncology ( Site 3901)
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Samsung Medical Center-Division of Hematology/Oncology ( Site 3900)
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Oslo universitetssykehus, Radiumhospitalet ( Site 4501)
Coordinator of this site? Confirm its status
OsloNorwayRecruiting
National University Hospital ( Site 3800)
Coordinator of this site? Confirm its status
SingaporeSingaporeRecruiting
Faculty of Medicine Siriraj Hospital ( Site 4102)
Coordinator of this site? Confirm its status
BangkoknoiThailandRecruiting
Songklanagarind hospital ( Site 4105)
Coordinator of this site? Confirm its status
Hat YaiThailandRecruiting
Chulalongkorn University ( Site 4104)
Coordinator of this site? Confirm its status
PathumwanThailandRecruiting
Chang Gung Memorial Hospital at Kaohsiung ( Site 4003)
Coordinator of this site? Confirm its status
Kaohsiung Niao Sung DistTaiwanRecruiting
Taichung Veterans General Hospital-Radiation Oncology ( Site 4008)
Coordinator of this site? Confirm its status
TaichungTaiwanRecruiting
China Medical University Hospital ( Site 4007)
Coordinator of this site? Confirm its status
TaichungTaiwanRecruiting
National Cheng Kung University Hospital ( Site 4001)
Coordinator of this site? Confirm its status
TainanTaiwanCompleted
National Taiwan University Hospital ( Site 4000)
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
Taipei Veterans General Hospital ( Site 4005)
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
Chang Gung Medical Foundation-Linkou Branch ( Site 4006)
Coordinator of this site? Confirm its status
TaoyuanTaiwanRecruiting
Hematology-Oncology Associates of Central NY, P.C. ( Site 4925)
Coordinator of this site? Confirm its status
East SyracuseUnited StatesRecruiting
UCLA Hematology/Oncology - Santa Monica ( Site 4905)
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 4907)
Coordinator of this site? Confirm its status
New YorkUnited StatesCompleted
UPMC Hillman Cancer Center-UPMC ( Site 4904)
Coordinator of this site? Confirm its status
PittsburghUnited StatesRecruiting
University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927)
Coordinator of this site? Confirm its status
TucsonUnited StatesRecruiting
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 3417)
Coordinator of this site? Confirm its status
AdanaTurkey (Türkiye)Recruiting
Hacettepe Universite Hastaneleri-oncology hospital ( Site 3402)
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Completed
Ankara Bilkent City Hospital-Medical Oncology ( Site 3405)
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Recruiting
Memorial Ankara Hastanesi-Medical Oncology ( Site 3408)
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Completed
Atatürk Üniversitesi-onkoloji ( Site 3416)
Coordinator of this site? Confirm its status
ErzurumTurkey (Türkiye)Recruiting
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3403)
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Recruiting
I.E.U. Medical Point Hastanesi-Oncology ( Site 3406)
Coordinator of this site? Confirm its status
IzmirTurkey (Türkiye)Completed

This page is information, not medical advice. Discuss any trial with your doctor.