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New hope for advanced esophageal cancer: combo therapy trial launches

NCT ID NCT06780111

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 14 times

Summary

This study tests new drug combinations (including an antibody-drug conjugate) with the immunotherapy pembrolizumab, with or without chemotherapy, for people with advanced esophageal cancer that cannot be removed by surgery or has spread. About 298 participants will join to see if the treatments are safe and help shrink tumors. The goal is to find better options for this hard-to-treat cancer.

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 298 people

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

Started

Jul 2025

Expected to finish

Jan 2032

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.

Inclusion Criteria The main inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic squamous cell carcinoma of the esophagus in first-line (1L) setting. * Has measurable disease per RECIST 1.1 as assessed by the local site. investigator or designee/radiology assessment and verified by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions. * Has had AEs due to previous anticancer therapies that have recovered to ≤Grade 1 or baseline. Endocrine-related AEs that are adequately treated with hormone replacement are elegible. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART). * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Has adequate organ function. Exclusion Criteria The main exclusion criteria include but are not limited to the following: * Has had systemic anticancer therapy for locally advanced unresectable or metastatic esophageal cancer. * Has tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula. * Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention. * Has clinically significant corneal disease, history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor. * Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention. * Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids. * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. * Has inadequate cardiac function assessed as by a corrected QT interval by Fredericia (QTcF) value ≥470 msec. * Has clinically significant cardiovascular disease within 6 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. * Has peripheral neuropathy ≥ Grade 2. * Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention. * Has known additional malignancy that is progressing or has required active treatment within the past 3 years. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has active autoimmune disease that has required systemic treatment in the past 2 years. * Has had a history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), has a current diagnosis of ILD, or has clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out. * Has active infection requiring systemic therapy. * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder.

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Conditions

The condition(s) this trial relates to.

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

    48 sites in 16 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

  • Aichi Cancer Center ( Site 9702)

    RECRUITING

    Nagoya, Aichi-ken, 464-8681, Japan

  • Ankara Bilkent Şehir Hastanesi ( Site 9403)

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Asan Medical Center ( Site 9901)

    RECRUITING

    Seoul, 05505, South Korea

  • Beijing Cancer Hospital ( Site 9500)

    RECRUITING

    Beijing, Beijing Municipality, 130021, China

  • Bradford Hill Norte ( Site 1405)

    RECRUITING

    Antofagasta, 1263521, Chile

  • Bradfordhill ( Site 1401)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • C.H.R.U. de Brest - Hopital Cavale Blanche ( Site 9104)

    RECRUITING

    Brest, Finistere, 29609, France

  • CHU Lille - Institut Coeur Poumon ( Site 9100)

    RECRUITING

    Lille, Nord, 59037, France

  • Centro de Oncología de Precisión ( Site 1402)

    RECRUITING

    Santiago, Region M. de Santiago, 7560913, Chile

  • Chang Gung Memorial Hospital - Linkou Branch ( Site 1006)

    RECRUITING

    Taoyuan, 33305, Taiwan

  • China Medical University Hospital ( Site 1007)

    RECRUITING

    Taichung, 40707, Taiwan

  • Clínica Puerto Montt ( Site 1406)

    RECRUITING

    Port Montt, Los Lagos Region, 5500243, Chile

  • Clínica UC San Carlos de Apoquindo ( Site 1403)

    RECRUITING

    Santiago, Region M. de Santiago, 7620002, Chile

  • FALP ( Site 1400)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 1807)

    RECRUITING

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

  • Hacettepe Universite Hastaneleri ( Site 9401)

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Henan Cancer Hospital ( Site 9509)

    RECRUITING

    Zhengzhou, Henan, 450008, China

  • Hopitaux Universitaires de Geneve HUG. ( Site 1701)

    RECRUITING

    Geneva, 1211, Switzerland

  • Hospital Nossa Senhora da Conceicao ( Site 1300)

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 91010-004, Brazil

  • IBCC - Instituto Brasileiro de Controle do Cancer ( Site 1303)

    RECRUITING

    São Paulo, São Paulo, 03102-002, Brazil

  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1302)

    RECRUITING

    São Paulo, 01246-000, Brazil

  • Istituto Oncologico Veneto IRCCS ( Site 9202)

    RECRUITING

    Padova, Veneto, 35128, Italy

  • Kantonsspital Graubuenden ( Site 1700)

    RECRUITING

    Chur, Kanton Graubünden, 7000, Switzerland

  • Kaohsiung Chang Gung Memorial Hospital ( Site 1003)

    RECRUITING

    Kaohsiung City, 83301, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 1009)

    RECRUITING

    Kaoshiung, Kaohsiung, 807, Taiwan

  • Liga Norte Riograndense Contra o Cancer ( Site 1301)

    RECRUITING

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

  • Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 9000)

    RECRUITING

    Brno, Brno-mesto, 656 53, Czechia

  • Memorial Ankara Hastanesi ( Site 9406)

    RECRUITING

    Ankara, 06520, Turkey (Türkiye)

  • National Cancer Center ( Site 9902)

    RECRUITING

    Goyang-si, Kyonggi-do, 10408, South Korea

  • National Cancer Center Hospital ( Site 9700)

    RECRUITING

    Chūō, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East ( Site 9701)

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital ( Site 1001)

    RECRUITING

    Tainan, 704302, Taiwan

  • National Taiwan University Hospital ( Site 1000)

    RECRUITING

    Taipei, 100225, Taiwan

  • National University Hospital ( Site 9800)

    RECRUITING

    Singapore, Central Singapore, 119074, Singapore

  • Oslo Universitetssykehus Radiumhospitalet ( Site 1501)

    RECRUITING

    Oslo, 0379, Norway

  • Ospedale San Raffaele-Oncologia Medica ( Site 9201)

    RECRUITING

    Milan, Lombardy, 20132, Italy

  • Pitie Salpetriere University Hospital ( Site 9102)

    RECRUITING

    Paris, 75013, France

  • Ramathibodi Hospital ( Site 1103)

    RECRUITING

    Ratchathewi, Bangkok, 10400, Thailand

  • Samsung Medical Center ( Site 9900)

    RECRUITING

    Seoul, 06351, South Korea

  • Songklanagarind hospital ( Site 1101)

    RECRUITING

    Hat Yai, Changwat Songkhla, 90110, Thailand

  • Taipei Veterans General Hospital ( Site 1005)

    RECRUITING

    Taipei, 11217, Taiwan

  • The First Affiliated Hospital of Nanchang University ( Site 9505)

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Xiamen University ( Site 9503)

    RECRUITING

    Xiamen, Fujian, 361003, China

  • The Second Affiliated Hospital of Anhui Medical University ( Site 9511)

    RECRUITING

    Hefei, Anhui, 230601, China

  • UPMC Hillman Cancer Center ( Site 1904)

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Universitaetsklinikum Duesseldorf ( Site 1808)

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Universitätsklinikum Carl Gustav Carus - Medical Oncology ( Site 1806)

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • Xuzhou Central Hospital ( Site 9512)

    RECRUITING

    Xuzhou, Jiangsu, 221000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.