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New hope for esophageal cancer: drug cocktail trial launches

NCT ID NCT05319730

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 03, 2026 · Updated 5 times

Summary

This study tests several new drug combinations, with or without the immunotherapy pembrolizumab, in people with advanced esophageal cancer that has continued to grow after standard treatment. About 230 participants will receive different drug regimens to see which are safest and most effective. The goal is to find better options for this hard-to-treat cancer.

What this could mean

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

Active substance
Pembrolizumab, MK-4830, Lenvatinib, Sacituzumab tirumotecan, Paclitaxel, Irinotecan
What this could lead to
If successful, this could provide new treatment options for people with advanced esophageal cancer whose disease has worsened after initial therapy.
What could go wrong
This is an early-phase trial (phase 1/2) with a small number of participants, so the benefits are uncertain. The drug combinations may cause significant side effects, and not all participants will respond.

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

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Apr 2029

An estimate. End dates often move.

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 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 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 history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * 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 * 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 * 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 * 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

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    49 sites in 14 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 3417)

    RECRUITING

    Adana, 01140, Turkey (Türkiye)

  • Aichi Cancer Center ( Site 3702)

    RECRUITING

    Nagoya, Aichi-ken, 464-8681, Japan

  • Anhui Provincial Hospital ( Site 3501)

    RECRUITING

    Hefei, Anhui, 230001, China

  • Ankara Bilkent City Hospital-Medical Oncology ( Site 3405)

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Asan Medical Center-Department of Oncology ( Site 3901)

    RECRUITING

    Seoul, 05505, South Korea

  • Atatürk Üniversitesi-onkoloji ( Site 3416)

    RECRUITING

    Erzurum, 25070, Turkey (Türkiye)

  • Azienda Ospedaliero Universitaria Pisana ( Site 3206)

    RECRUITING

    Pisa, Tuscany, 56126, Italy

  • Beijing Cancer hospital-Digestive Oncology ( Site 3500)

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Centro de Oncología de Precisión-Oncology ( Site 4404)

    RECRUITING

    Santiago, Region M. de Santiago, 7560908, Chile

  • Chang Gung Medical Foundation-Linkou Branch ( Site 4006)

    RECRUITING

    Taoyuan, 33305, Taiwan

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 4003)

    RECRUITING

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

  • Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 4804)

    COMPLETED

    Berlin, 13353, Germany

  • China Medical University Hospital ( Site 4007)

    RECRUITING

    Taichung, 404332, Taiwan

  • Chulalongkorn University ( Site 4104)

    RECRUITING

    Pathumwan, Bangkok, 10330, Thailand

  • Clínica UC San Carlos de Apoquindo ( Site 4405)

    RECRUITING

    Santiago, Region M. de Santiago, 7620002, Chile

  • Clínica las Condes ( Site 4403)

    COMPLETED

    Santiago, Region M. de Santiago, 7591047, Chile

  • Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 4907)

    COMPLETED

    New York, New York, 10032, United States

  • FALP-UIDO ( Site 4400)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Faculty of Medicine Siriraj Hospital ( Site 4102)

    RECRUITING

    Bangkoknoi, Bangkok, 10700, Thailand

  • First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 3506)

    RECRUITING

    Huai'an, Jiangsu, 223300, China

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3200)

    RECRUITING

    Milan, Lombardy, 20133, Italy

  • HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 4807)

    RECRUITING

    Erdgeschoss, Free and Hanseatic City of Hamburg, 22297, Germany

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 3402)

    COMPLETED

    Ankara, 06230, Turkey (Türkiye)

  • Hematology-Oncology Associates of Central NY, P.C. ( Site 4925)

    RECRUITING

    East Syracuse, New York, 13057, United States

  • Henan Cancer Hospital ( Site 3518)

    RECRUITING

    Zhengzhou, Henan, 450008, China

  • Hospital Nossa Senhora da Conceição ( Site 4301)

    RECRUITING

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

  • Hôpitaux Universitaires de Genève (HUG) ( Site 4702)

    RECRUITING

    Geneva, Canton of Geneva, 1211, Switzerland

  • I.E.U. Medical Point Hastanesi-Oncology ( Site 3406)

    COMPLETED

    Izmir, 35575, Turkey (Türkiye)

  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 4300)

    RECRUITING

    São Paulo, 01246-000, Brazil

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 3207)

    RECRUITING

    Meldola, Emilia-Romagna, 47014, Italy

  • Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 4801)

    COMPLETED

    Frankfurt am Main, Hesse, 60488, Germany

  • Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative ( Site 3201)

    COMPLETED

    Milan, 20141, Italy

  • Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 3203)

    RECRUITING

    Padova, Veneto, 35128, Italy

  • Kantonsspital Graubünden-Medizin ( Site 4700)

    RECRUITING

    Chur, Kanton Graubünden, 7000, Switzerland

  • Liga Norte Riograndense Contra o Câncer ( Site 4303)

    RECRUITING

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

  • Memorial Ankara Hastanesi-Medical Oncology ( Site 3408)

    COMPLETED

    Ankara, 06520, Turkey (Türkiye)

  • National Cancer Center Hospital ( Site 3700)

    RECRUITING

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East ( Site 3701)

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital ( Site 4001)

    RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Hospital ( Site 4000)

    RECRUITING

    Taipei, 10002, Taiwan

  • National University Hospital ( Site 3800)

    RECRUITING

    Singapore, South West, 119074, Singapore

  • Oslo universitetssykehus, Radiumhospitalet ( Site 4501)

    RECRUITING

    Oslo, 0379, Norway

  • Ospedale San Raffaele-Oncologia Medica ( Site 3202)

    RECRUITING

    Milan, 20132, Italy

  • Saitama Prefectural Cancer Center ( Site 3703)

    RECRUITING

    Kitaadachi-gun, Saitama, 3620806, Japan

  • Samsung Medical Center-Division of Hematology/Oncology ( Site 3900)

    RECRUITING

    Seoul, 06351, South Korea

  • Shanghai Chest Hospital-Esophageal surgery department ( Site 3513)

    RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

  • Shizuoka Cancer Center ( Site 3704)

    RECRUITING

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

  • Songklanagarind hospital ( Site 4105)

    RECRUITING

    Hat Yai, Changwat Songkhla, 90110, Thailand

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3403)

    RECRUITING

    Istanbul, 34722, Turkey (Türkiye)

  • Taichung Veterans General Hospital-Radiation Oncology ( Site 4008)

    RECRUITING

    Taichung, 407, Taiwan

  • Taipei Veterans General Hospital ( Site 4005)

    RECRUITING

    Taipei, 112, Taiwan

  • The First Affiliated Hospital of Xiamen University ( Site 3516)

    RECRUITING

    Xiamen, Fujian, 361003, China

  • The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 3510)

    RECRUITING

    Xinxiang, Henan, 453100, China

  • UCLA Hematology/Oncology - Santa Monica ( Site 4905)

    RECRUITING

    Los Angeles, California, 90404, United States

  • UPMC Hillman Cancer Center-UPMC ( Site 4904)

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Universitaetsklinikum Duesseldorf ( Site 4802)

    COMPLETED

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927)

    RECRUITING

    Tucson, Arizona, 85719, United States

  • Zhejiang Cancer Hospital-Thoracic oncology ( Site 3511)

    RECRUITING

    Hangzhou, Zhejiang, 310022, China

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