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Study of Ifinatamab Deruxtecan and Pembrolizumab, With or Without Chemotherapy, for Patients With Untreated Advanced Esophageal Cancer

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for esophageal cancer, specifically a type called esophageal squamous cell carcinoma. The study will explore the effects of combining different treatments, including a new drug called Ifinatamab Deruxtecan and an existing medication known as Pembrolizumab (also referred to by its code name MK-3475). Some participants may also receive additional chemotherapy drugs, such as Oxaliplatin, Fluorouracil, and Calcium Folinate.

The purpose of the study is to evaluate the safety and tolerability of these treatment combinations and to determine the best dose for the new drug. Participants will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor how well the treatments work and how the body responds to them over time. This includes looking at how long the treatment effects last, how the disease progresses, and overall survival rates.

Throughout the study, researchers will also measure the levels of Ifinatamab Deruxtecan in the blood to understand how the drug is processed by the body. The study aims to provide valuable information on the effectiveness and safety of these treatment combinations for people with advanced esophageal cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants will be informed about the trial's purpose, procedures, and potential risks and benefits. Consent will be obtained to ensure understanding and agreement to participate.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of locally advanced unresectable or metastatic squamous cell carcinoma of the esophagus and ensuring measurable disease is present.

  3. Step 3

    Treatment phase

    Participants will receive a combination of investigational agents. The main medications include ifinatamab deruxtecan and pembrolizumab, both administered through intravenous infusion. The specific dosage and frequency will be determined by the study protocol.

    Some participants may also receive chemotherapy, which could include oxaliplatin, calcium folinate, and fluorouracil, all administered via intravenous infusion. The exact regimen will depend on the study group assignment.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, participants will be closely monitored for any side effects or adverse reactions. Regular follow-up visits will be scheduled to assess the treatment's effectiveness and participant well-being.

    Participants will undergo various tests and assessments, including imaging studies, to evaluate the response to treatment and adjust the regimen if necessary.

  5. Step 5

    End of treatment

    At the end of the treatment phase, participants will have a final assessment to determine the overall response to the investigational agents. This includes evaluating the duration of response and progression-free survival.

    Participants will be informed about the next steps, which may include continued monitoring or additional treatment options based on the study's findings.

Who can join the trial?

7 criteria

  • The patient must have a confirmed diagnosis of esophageal squamous cell carcinoma, which is a type of cancer in the esophagus.
  • The cancer must be in a stage that is locally advanced, cannot be removed by surgery, or has spread to other parts of the body.
  • The patient must have measurable disease, meaning the cancer can be measured by medical imaging tests. If the cancer was previously treated with radiation, it must show signs of growth to be considered measurable.
  • The patient must have side effects from previous cancer treatments that are mild (Grade 1) or have returned to the level they were before treatment. Exceptions are hair loss and skin color changes, which are not considered. Hormone-related side effects must be well-managed with medication, and nerve-related side effects must be mild (Grade 2) or less.
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which means they are fully active or have some symptoms but do not need bed rest during the day.
  • The patient must be within the age range of adults, as specified by the trial.
  • Both male and female patients are eligible to participate.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer besides esophageal squamous cell carcinoma cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.
  • Patients who have not recovered from previous treatments or surgeries cannot participate.
  • Patients with severe or uncontrolled medical conditions cannot participate. This includes conditions like uncontrolled high blood pressure or heart disease.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a severe allergic reaction to similar treatments in the past cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have an active infection that requires treatment cannot participate.
  • Patients with a history of drug or alcohol abuse that could interfere with the study cannot participate.
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Investigated drugs

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. Pembrolizumab blocks a specific protein on the surface of cancer cells, which allows your immune system to better recognize and attack these cells. This medication is used in the trial to see if it can help treat esophageal cancer when used alone or in combination with other treatments.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently a well-established medication in the field of oncology, with numerous studies and medical literature supporting its use. The main therapeutic indication for pembrolizumab in this trial is esophageal squamous cell carcinoma, a type of cancer affecting the esophagus. At the molecular level, pembrolizumab works by blocking a specific protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.

Investigated diseases

Esophageal squamous cell carcinoma – This is a type of cancer that forms in the squamous cells lining the esophagus, which is the tube that carries food from the throat to the stomach. It typically begins in the upper and middle parts of the esophagus. As the disease progresses, it can cause difficulty swallowing, weight loss, and chest pain. The cancer may spread to nearby lymph nodes and other organs. Over time, it can lead to narrowing of the esophagus, making it hard to swallow solid foods. The progression of the disease can vary, and it often requires medical evaluation to understand its development.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514273-22-00Protocol codeMK-3475-06EEstimated enrolment266 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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