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Combination Therapies for Esophageal Squamous Cell Carcinoma

This study is investigating new ways to treat esophageal squamous cell carcinoma (ESCC), a type of cancer in the tube connecting your throat to your stomach. Researchers are testing combinations of pembrolizumab (an immunotherapy that helps your immune system fight cancer) with I-DXd, and also with chemotherapy drugs like Leucovorin, Levoleucovorin, and 5-Fluorouracil (5-FU). You may be able to join if you have locally advanced unresectable (cannot be fully removed by surgery) or metastatic ESCC that has spread to other parts of your body, and it's your first time receiving treatment for this condition. The study aims to see how safe these combinations are and if they shrink tumors. The study plans to enroll 298 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 298 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events and objective response rate for up to approximately 77 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06780111

Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~298 participants
Updated 2026-09-17 on ClinicalTrials.gov
What's tested:PembrolizumabI-DXdLeucovorinLevoleucovorin5-Fluorouracil (5-FU)Oxaliplatin

At a glance

Recruiting sites
48 of 48 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase
Measured over Up to approximately 28 days
+2 more outcomes measured

Conditions

Esophageal Squamous Cell Carcinoma

Explore related trials

Esophageal Squamous Cell Carcinoma

NCT06780111

Where you'd take part

This study runs at 48 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Aichi Cancer Center ( Site 9702)

    Nagoya, Aichi-ken, Japanstudy coordinator listed

    Recruiting

  • Ankara Bilkent Şehir Hastanesi ( Site 9403)

    Ankara, Turkey (Türkiye)study coordinator listed

    Recruiting

  • Asan Medical Center ( Site 9901)

    Seoul, South Koreastudy coordinator listed

    Recruiting

  • Beijing Cancer Hospital ( Site 9500)

    Beijing, Beijing Municipality, Chinastudy coordinator listed

    Recruiting

  • Bradford Hill Norte ( Site 1405)

    Antofagasta, Chilestudy coordinator listed

    Recruiting

  • Bradfordhill ( Site 1401)

    Santiago, Region M. de Santiago, Chilestudy coordinator listed

    Recruiting

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

    Brest, Finistere, Francestudy coordinator listed

    Recruiting

  • Centro de Oncología de Precisión ( Site 1402)

    Santiago, Region M. de Santiago, Chilestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In PhaseUp to approximately 28 days

    Percentage of participants experiencing toxicities that are possibly, probably, or definitely related to study intervention; that meet pre-defined severity criteria; and result in a change in the given dose.

  • Percentage of Participants who Experience an Adverse Event (AE)Up to approximately 77 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience an AE will be reported.

  • Objective Response Rate (ORR)Up to approximately 77 months

    ORR is defined as a confirmed complete response (CR: the disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). The percentage of participants who experience CR or PR as assessed by BICR will be presented.