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New cocktail of drugs tested for tough esophageal cancer

NCT ID NCT05342636

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested several combinations of the immunotherapy drug pembrolizumab (Keytruda) with other drugs in 90 people with advanced esophageal cancer that had already progressed after one prior treatment. The goal was to see if these combinations are safe and can shrink tumors or slow the cancer's growth. The trial is now complete, and results will help decide which combinations to study further.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pembrolizumab (Keytruda) plus other drugs (favezelimab, MK-4830, lenvatinib, irinotecan, chemotherapy)
What this could lead to
If successful, this could point toward new treatment options for advanced esophageal cancer that has stopped responding to standard therapy.
What could go wrong
This is an early-phase trial with only 90 participants, so results may not apply to all patients. The drug combinations may cause side effects and may not work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

90 people

The number who actually took part.

Started

Jul 2022

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * 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 Exclusion Criteria: * Direct invasion into adjacent organs such as the aorta or trachea * 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

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 Esophageal Neoplasms esophageal squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal squamous cell carcinoma (ESCC)

Contacts and locations

Locations

  • Acibadem Altunizade Hospital-Oncology ( Site 1407)

    Üsküdar / İstanbul, Istanbul, 34662, Turkey (Türkiye)

  • Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1417)

    Adana, 01140, Turkey (Türkiye)

  • Aichi Cancer Center Hospital ( Site 1702)

    Nagoya, Aichi-ken, 464-8681, Japan

  • Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1410)

    Antalya, 07059, Turkey (Türkiye)

  • Ankara City Hospital-Medical Oncology ( Site 1405)

    Ankara, 06800, Turkey (Türkiye)

  • Asan Medical Center-Department of Oncology ( Site 1901)

    Seoul, 05505, South Korea

  • Atatürk Üniversitesi-onkoloji ( Site 1416)

    Erzurum, 25070, Turkey (Türkiye)

  • Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan ( Site 1104)

    Brest, Finistere, 29200, France

  • Chang Gung Medical Foundation-Linkou Branch ( Site 2006)

    Taoyuan, 333, Taiwan

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 2003)

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

  • Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 2804)

    Berlin, 13353, Germany

  • China Medical University Hospital ( Site 2007)

    Taichung, 404332, Taiwan

  • Chulalongkorn University ( Site 2104)

    Bangkok, Bangkok, 10330, Thailand

  • Clínica las Condes ( Site 2403)

    Santiago, Region M. de Santiago, 7591047, Chile

  • FALP-UIDO ( Site 2400)

    Santiago, Region M. de Santiago, 7500921, Chile

  • Faculty of Medicine Siriraj Hospital ( Site 2102)

    Bangkok, Bangkok, 10700, Thailand

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1200)

    Milan, Lombardy, 20133, Italy

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 1402)

    Ankara, 06230, Turkey (Türkiye)

  • Hopital Claude Huriez - CHU de Lille ( Site 1100)

    Lille, Nord, 59037, France

  • Hospital Nossa Senhora da Conceição ( Site 2301)

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

  • Hôpitaux Universitaires de Genève (HUG) ( Site 2702)

    Geneva, Canton of Geneva, 1211, Switzerland

  • I.E.U. Medical Point Hastanesi-Oncology ( Site 1406)

    Izmir, Karsiyaka, İzmir, 009035575, Turkey (Türkiye)

  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 2300)

    São Paulo, São Paulo, 01246-000, Brazil

  • Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 2801)

    Frankfurt am Main, Hesse, 60488, Germany

  • Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (

    Milan, 20141, Italy

  • Istituto Oncologico Veneto IRCCS ( Site 1205)

    Padova, 35128, Italy

  • Kantonsspital Graubünden-Medizin ( Site 2700)

    Chur, Kanton Graubünden, 7000, Switzerland

  • Liga Norte Riograndense Contra o Câncer ( Site 2303)

    Natal, Rio Grande do Norte, 59062-000, Brazil

  • Memorial Ankara Hastanesi-Medical Oncology ( Site 1408)

    Ankara, 06520, Turkey (Türkiye)

  • National Cancer Center Hospital ( Site 1700)

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East ( Site 1701)

    Kashiwa, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital ( Site 2001)

    Tainan, 704, Taiwan

  • National Taiwan University Hospital ( Site 2000)

    Taipei, 10002, Taiwan

  • National University Hospital ( Site 1800)

    Singapore, South West, 119074, Singapore

  • Oslo universitetssykehus, Radiumhospitalet ( Site 2501)

    Oslo, 0310, Norway

  • Ospedale San Raffaele-Oncologia Medica ( Site 1206)

    Milan, Lombardy, 20132, Italy

  • Pitie Salpetriere University Hospital ( Site 1102)

    Paris, Orne, 75013, France

  • Saitama Prefectural Cancer Center ( Site 1703)

    Ina-machi, Saitama, 362-0806, Japan

  • Samsung Medical Center-Division of Hematology/Oncology ( Site 1900)

    Seoul, 06351, South Korea

  • Shizuoka Cancer Center ( Site 1704)

    Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777, Japan

  • Songklanagarind hospital ( Site 2105)

    Hat Yai, Changwat Songkhla, 90110, Thailand

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1403)

    Istanbul, 34722, Turkey (Türkiye)

  • Taichung Veterans General Hospital-Radiation Oncology ( Site 2008)

    Taichung, 407, Taiwan

  • Taipei Veterans General Hospital ( Site 2005)

    Taipei, 112, Taiwan

  • Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 2806)

    Dresden, Saxony, 01307, Germany

  • Universitaetsklinikum Duesseldorf ( Site 2802)

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

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