A Study of Combination Therapies With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer (MK-3475-06A)
NCT ID: NCT05342636
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
120 participants
INTERVENTIONAL
2022-07-27
2025-12-05
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pembrolizumab plus chemotherapy
Participants will receive pembrolizumab intravenously plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Irinotecan
180 mg/m\^2 administered via IV infusion on day 1 of every 14-day cycle.
Paclitaxel
80-100 mg/m\^2 administered via IV infusion on Days 1, 8 and 15 of every 28 day cycle
Pembrolizumab
200 mg administered via intravenous (IV) infusion every 3 weeks (Q3W)
Coformulation Favezelimab/Pembrolizumab plus Chemotherapy
Participants will receive coformulation of favezelimab/pembrolizumab administered intravenously plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Irinotecan
180 mg/m\^2 administered via IV infusion on day 1 of every 14-day cycle.
Paclitaxel
80-100 mg/m\^2 administered via IV infusion on Days 1, 8 and 15 of every 28 day cycle
Coformulation favezelimab/pembrolizumab
800 mg favezelimab + 200 mg pembrolizumab administered via IV infusion on day 1 and then Q3W
Pembrolizumab plus MK-4830 plus Chemotherapy
Participants will receive pembrolizumab intravenously plus MK-4830 plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to approximately 2 years.
MK-4830
800 mg administered via IV infusion Q3W
Irinotecan
180 mg/m\^2 administered via IV infusion on day 1 of every 14-day cycle.
Paclitaxel
80-100 mg/m\^2 administered via IV infusion on Days 1, 8 and 15 of every 28 day cycle
Pembrolizumab
200 mg administered via intravenous (IV) infusion every 3 weeks (Q3W)
Pembrolizumab plus MK-4830 plus lenvatinib
Participants will receive pembrolizumab intravenously plus MK-4830 plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.
MK-4830
800 mg administered via IV infusion Q3W
Lenvatinib
20 mg administered via oral capsules each day
Pembrolizumab
200 mg administered via intravenous (IV) infusion every 3 weeks (Q3W)
Interventions
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MK-4830
800 mg administered via IV infusion Q3W
Lenvatinib
20 mg administered via oral capsules each day
Irinotecan
180 mg/m\^2 administered via IV infusion on day 1 of every 14-day cycle.
Paclitaxel
80-100 mg/m\^2 administered via IV infusion on Days 1, 8 and 15 of every 28 day cycle
Pembrolizumab
200 mg administered via intravenous (IV) infusion every 3 weeks (Q3W)
Coformulation favezelimab/pembrolizumab
800 mg favezelimab + 200 mg pembrolizumab administered via IV infusion on day 1 and then Q3W
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* 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:
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Liga Norte Riograndense Contra o Câncer ( Site 2303)
Natal, Rio Grande do Norte, Brazil
Hospital Nossa Senhora da Conceição ( Site 2301)
Porto Alegre, Rio Grande do Sul, Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 2300)
São Paulo, São Paulo, Brazil
FALP-UIDO ( Site 2400)
Santiago, Region M. de Santiago, Chile
Clínica las Condes ( Site 2403)
Santiago, Region M. de Santiago, Chile
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan ( Site 1104)
Brest, Finistere, France
Hopital Claude Huriez - CHU de Lille ( Site 1100)
Lille, Nord, France
Pitie Salpetriere University Hospital ( Site 1102)
Paris, Orne, France
Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 2801)
Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Duesseldorf ( Site 2802)
Düsseldorf, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 2806)
Dresden, Saxony, Germany
Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 2804)
Berlin, , Germany
Ospedale San Raffaele-Oncologia Medica ( Site 1206)
Milan, Lombardy, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1200)
Milan, Lombardy, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (
Milan, , Italy
Istituto Oncologico Veneto IRCCS ( Site 1205)
Padua, , Italy
Aichi Cancer Center Hospital ( Site 1702)
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 1701)
Kashiwa, Chiba, Japan
Saitama Prefectural Cancer Center ( Site 1703)
Ina-machi, Saitama, Japan
Shizuoka Cancer Center ( Site 1704)
Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital ( Site 1700)
Chuo-ku, Tokyo, Japan
Oslo universitetssykehus, Radiumhospitalet ( Site 2501)
Oslo, , Norway
National University Hospital ( Site 1800)
Singapore, South West, Singapore
Asan Medical Center-Department of Oncology ( Site 1901)
Seoul, , South Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 1900)
Seoul, , South Korea
Hôpitaux Universitaires de Genève (HUG) ( Site 2702)
Geneva, Canton of Geneva, Switzerland
Kantonsspital Graubünden-Medizin ( Site 2700)
Chur, Kanton Graubünden, Switzerland
Chang Gung Memorial Hospital at Kaohsiung ( Site 2003)
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
China Medical University Hospital ( Site 2007)
Taichung, , Taiwan
Taichung Veterans General Hospital-Radiation Oncology ( Site 2008)
Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 2001)
Tainan, , Taiwan
National Taiwan University Hospital ( Site 2000)
Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 2005)
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 2006)
Taoyuan District, , Taiwan
Chulalongkorn University ( Site 2104)
Bangkok, Bangkok, Thailand
Faculty of Medicine Siriraj Hospital ( Site 2102)
Bangkok, Bangkok, Thailand
Songklanagarind hospital ( Site 2105)
Hat Yai, Changwat Songkhla, Thailand
Acibadem Altunizade Hospital-Oncology ( Site 1407)
Üsküdar / İstanbul, Istanbul, Turkey (Türkiye)
I.E.U. Medical Point Hastanesi-Oncology ( Site 1406)
Izmir, Karsiyaka, İzmir, Turkey (Türkiye)
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1417)
Adana, , Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1402)
Ankara, , Turkey (Türkiye)
Memorial Ankara Hastanesi-Medical Oncology ( Site 1408)
Ankara, , Turkey (Türkiye)
Ankara City Hospital-Medical Oncology ( Site 1405)
Ankara, , Turkey (Türkiye)
Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1410)
Antalya, , Turkey (Türkiye)
Atatürk Üniversitesi-onkoloji ( Site 1416)
Erzurum, , Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1403)
Istanbul, , Turkey (Türkiye)
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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2031220197
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-505188-36-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1291-1899
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-005405-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3475-06A
Identifier Type: -
Identifier Source: org_study_id