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Study of Pembrolizumab and Drug Combination for Patients with Advanced Esophageal Cancer

Verified siteRegistered 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 advanced esophageal cancer, specifically a type called esophageal squamous cell carcinoma (ESCC). The study will explore the effects of different combination therapies, including the use of pembrolizumab (also known by its code name MK-3475), paclitaxel, lenvatinib, irinotecan hydrochloride, MK-4280A (which includes pembrolizumab and favezelimab), and MK-4830. These treatments will be administered either alone or in combination with each other or with chemotherapy.

The purpose of the study is to evaluate the safety and effectiveness of these treatments in patients who have not previously received treatment targeting PD-1/PD-L1, which are proteins involved in the immune system's response to cancer. Participants will receive the treatments through intravenous infusion or in the form of capsules for oral use, depending on the specific medication. The study will monitor how well the treatments are tolerated and their impact on the cancer's progression.

Throughout the study, participants will be closely observed for any side effects or adverse reactions to the treatments. The trial aims to determine the best combination of therapies to improve outcomes for patients with advanced esophageal cancer. The study will also assess how long the treatments can keep the cancer from worsening and the overall survival of participants. This research is part of an ongoing effort to find more effective treatments for this challenging condition.

The research process

The trial runs in 6 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, the participant is confirmed to have advanced esophageal squamous cell carcinoma (ESCC) that is either metastatic or locally advanced and cannot be surgically removed.

    The participant must have experienced disease progression after one prior standard therapy and have a tumor sample available for analysis.

  2. Step 2

    Safety lead-in phase

    The initial phase focuses on evaluating the safety and tolerability of the combination treatments.

    Participants receive treatments that may include pembrolizumab (KEYTRUDA) administered as an intravenous infusion, paclitaxel as an intravenous infusion, lenvatinib in capsule form for oral use, irinotecan as an intravenous infusion, and other investigational agents.

    The objective is to monitor for any dose-limiting toxicities and adverse events.

  3. Step 3

    Efficacy phase

    Following the safety lead-in phase, the study progresses to assess the effectiveness of the treatments.

    The primary focus is on the objective response rate, which is the proportion of participants whose cancer shrinks or disappears after treatment.

    Secondary outcomes include progression-free survival, duration of response, and overall survival.

  4. Step 4

    Treatment administration

    Participants receive treatments according to the study protocol, which may involve a combination of drugs administered through intravenous infusions or oral capsules.

    The specific regimen and duration depend on the participant's response and tolerance to the treatment.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, participants are regularly monitored for any adverse events and treatment effectiveness.

    Regular assessments are conducted to evaluate the participant's health status and response to the treatment.

  6. Step 6

    Study completion

    The study is estimated to conclude by September 21, 2026.

    Upon completion, participants may undergo final assessments to determine the overall impact of the treatment on their condition.

Who can join the trial?

7 criteria

  • Must have a confirmed diagnosis of metastatic or locally advanced unresectable esophageal squamous cell carcinoma (ESCC). This means the cancer has spread or cannot be removed by surgery.
  • Must have shown disease progression, meaning the cancer has gotten worse, after one previous standard treatment.
  • Must have a tumor sample available for analysis. This can be a new sample or one from previous tests.
  • Must have blood pressure that is well-controlled, whether or not they are taking medication for it.
  • If the patient had side effects from previous cancer treatments, these must have improved to a mild level or returned to what they were before treatment. If the side effects are related to hormones and are being treated with hormone replacement, or if the patient has mild nerve damage (neuropathy), they can still participate.
  • Both men and women can participate in the study.
  • Participants should not be from vulnerable populations, meaning groups that might need special protection or care.
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Investigated drugs

  • Pembrolizumab (MK-3475)

    is a medication used in this study to help the body's immune system fight cancer. It works by blocking a specific protein that prevents the immune system from attacking cancer cells. This medication is being tested in combination with other treatments to see if it can improve outcomes for patients with advanced esophageal cancer.

  • Chemotherapy

    is a type of cancer treatment that uses drugs to destroy cancer cells. In this study, chemotherapy is used alongside other investigational agents to determine if the combination can be more effective in treating advanced esophageal cancer. Chemotherapy targets rapidly dividing cells, which include cancer cells, to stop their growth and spread.

What is already known about the treatment

Pembrolizumab – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating advanced esophageal squamous cell carcinoma. It is a well-established drug in medical literature, primarily used for its immune-enhancing properties. Pembrolizumab works by blocking a specific protein called PD-1 on the surface of immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor and is commonly used in various cancer treatments.

Investigated diseases

Advanced esophageal squamous cell carcinoma – This is a type of cancer that forms in the cells lining the esophagus, specifically the squamous cells. It is considered advanced when it has spread beyond the esophagus to nearby tissues or other parts of the body. The disease often begins with difficulty swallowing and may progress to cause weight loss, chest pain, and persistent cough. As it advances, it can lead to more severe symptoms due to obstruction of the esophagus or spread to other organs. The progression of this cancer can vary, but it typically involves the growth of tumors and potential metastasis. Understanding the progression is crucial for managing symptoms and improving quality of life.
Trial detailsLast updated 31 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-505188-36-00Protocol codeMK-3475-06AEstimated enrolment91 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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