Fact CheckerSign in

NCT05342636CompletedPhase 1/2

A Study of Combination Therapies With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer (MK-3475-06A)

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 naïve to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06A.

Source: ClinicalTrials.gov · Last updated 17 Dec 2025

Brief summary (registry, in English)

This is a phase I/II multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of investigational agents with pembrolizumab, plus chemotherapy or lenvatinib, for the treatment of participants with advanced esophageal cancer who have failed 1 prior line of therapy and have not been previously exposed to programmed cell death 1 protein (PD-1)/ programmed cell death ligand 1 (PD-L1) based treatment. With protocol amendment 5 (effective: 17-November-2023), enrollment in study arms "Pembrolizumab plus MK-4830 plus Chemotherapy" and "Pembrolizumab plus MK-4830 plus lenvatinib" is discontinued.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
90 (actual)
First submitted
19 Apr 2022
Start date
27 Jul 2022
Primary completion date
5 Dec 2025
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT05342636
EU CT number
2023-505188-36-00
EudraCT number
2021-005405-26

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 90
  • From 27 Jul 2022 to the primary completion date, 5 Dec 2025
  • 46 sites in 13 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 received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
  • Has had a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization
  • Has significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization

Other illness

  • 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
  • Active autoimmune disease that has required systemic treatment in past 2 years
  • History of human immunodeficiency virus (HIV) infection
  • History of Hepatitis B or known active Hepatitis C virus infection
  • History of allogenic tissue/solid organ transplant
  • Clinically significant cardiovascular disease within 12 months from first dose of study intervention
  • Participants with known gastrointestinal (GI) malabsorption or any other condition that may affect the absorption of lenvatinib
  • Has risk for significant GI bleeding, such as:

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 ESCC
  • Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy.
  • Has an evaluable baseline tumor sample (newly obtained or archival) for analysis
  • Has adequately controlled blood pressure (BP) with or without antihypertensive medications
  • 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 (46)

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 2303)
Coordinator of this site? Confirm its status
NatalBrazilUnknown status
Hospital Nossa Senhora da Conceição ( Site 2301)
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 2300)
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Kantonsspital Graubünden-Medizin ( Site 2700)
Coordinator of this site? Confirm its status
ChurSwitzerlandUnknown status
Hôpitaux Universitaires de Genève (HUG) ( Site 2702)
Coordinator of this site? Confirm its status
GenevaSwitzerlandUnknown status
Clínica las Condes ( Site 2403)
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
FALP-UIDO ( Site 2400)
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 2804)
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 2806)
Coordinator of this site? Confirm its status
DresdenGermanyUnknown status
Universitaetsklinikum Duesseldorf ( Site 2802)
Coordinator of this site? Confirm its status
DüsseldorfGermanyUnknown status
Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 2801)
Coordinator of this site? Confirm its status
Frankfurt am MainGermanyUnknown status
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan ( Site 1104)
Coordinator of this site? Confirm its status
BrestFranceUnknown status
Hopital Claude Huriez - CHU de Lille ( Site 1100)
Coordinator of this site? Confirm its status
LilleFranceUnknown status
Pitie Salpetriere University Hospital ( Site 1102)
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Ospedale San Raffaele-Oncologia Medica ( Site 1206)
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1200)
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Istituto Oncologico Veneto IRCCS ( Site 1205)
Coordinator of this site? Confirm its status
PadovaItalyUnknown status
National Cancer Center Hospital ( Site 1700)
Coordinator of this site? Confirm its status
Chuo-kuJapanUnknown status
Saitama Prefectural Cancer Center ( Site 1703)
Coordinator of this site? Confirm its status
Ina-machiJapanUnknown status
National Cancer Center Hospital East ( Site 1701)
Coordinator of this site? Confirm its status
KashiwaJapanUnknown status
Shizuoka Cancer Center ( Site 1704)
Coordinator of this site? Confirm its status
Nagaizumi-cho,Sunto-gunJapanUnknown status
Aichi Cancer Center Hospital ( Site 1702)
Coordinator of this site? Confirm its status
NagoyaJapanUnknown status
Asan Medical Center-Department of Oncology ( Site 1901)
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Samsung Medical Center-Division of Hematology/Oncology ( Site 1900)
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Oslo universitetssykehus, Radiumhospitalet ( Site 2501)
Coordinator of this site? Confirm its status
OsloNorwayUnknown status
National University Hospital ( Site 1800)
Coordinator of this site? Confirm its status
SingaporeSingaporeUnknown status
Chulalongkorn University ( Site 2104)
Coordinator of this site? Confirm its status
BangkokThailandUnknown status
Faculty of Medicine Siriraj Hospital ( Site 2102)
Coordinator of this site? Confirm its status
BangkokThailandUnknown status
Songklanagarind hospital ( Site 2105)
Coordinator of this site? Confirm its status
Hat YaiThailandUnknown status
Chang Gung Memorial Hospital at Kaohsiung ( Site 2003)
Coordinator of this site? Confirm its status
Kaohsiung Niao Sung DistTaiwanUnknown status
China Medical University Hospital ( Site 2007)
Coordinator of this site? Confirm its status
TaichungTaiwanUnknown status
Taichung Veterans General Hospital-Radiation Oncology ( Site 2008)
Coordinator of this site? Confirm its status
TaichungTaiwanUnknown status
National Cheng Kung University Hospital ( Site 2001)
Coordinator of this site? Confirm its status
TainanTaiwanUnknown status
Taipei Veterans General Hospital ( Site 2005)
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
National Taiwan University Hospital ( Site 2000)
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
Chang Gung Medical Foundation-Linkou Branch ( Site 2006)
Coordinator of this site? Confirm its status
TaoyuanTaiwanUnknown status
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1417)
Coordinator of this site? Confirm its status
AdanaTurkey (Türkiye)Unknown status
Ankara City Hospital-Medical Oncology ( Site 1405)
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Unknown status
Memorial Ankara Hastanesi-Medical Oncology ( Site 1408)
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Unknown status
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1402)
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Unknown status
Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1410)
Coordinator of this site? Confirm its status
AntalyaTurkey (Türkiye)Unknown status
Atatürk Üniversitesi-onkoloji ( Site 1416)
Coordinator of this site? Confirm its status
ErzurumTurkey (Türkiye)Unknown status
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1403)
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Unknown status
I.E.U. Medical Point Hastanesi-Oncology ( Site 1406)
Coordinator of this site? Confirm its status
Izmir, KarsiyakaTurkey (Türkiye)Unknown status
Acibadem Altunizade Hospital-Oncology ( Site 1407)
Coordinator of this site? Confirm its status
Üsküdar / İstanbulTurkey (Türkiye)Unknown status

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