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Study on the Long-term Safety and Efficacy of Pembrolizumab and Lenvatinib for Patients with Advanced Tumors

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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 the effects of treatments for advanced tumors. The study involves two main medications: Lenvatinib and Pembrolizumab. Lenvatinib is taken orally in the form of capsules, while Pembrolizumab, also known by its code name MK-3475, is administered through an intravenous infusion, which means it is given directly into a vein. The purpose of this study is to evaluate the long-term safety and effectiveness of these treatments in participants who are already receiving them as part of other studies.

Participants in this study will continue their treatment with either Lenvatinib, Pembrolizumab, or a combination of both, depending on their previous treatment plan. The study will monitor participants over a period to assess their overall survival, which refers to the length of time participants live after starting the treatment. Additionally, the study will track the duration of response to the treatment, meaning how long the treatment continues to be effective, and any side effects or adverse events that may occur.

This study is an extension of previous research, allowing participants to continue receiving their current treatment. It aims to provide valuable information on the long-term outcomes of using Lenvatinib and Pembrolizumab for treating advanced tumors. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the effectiveness of the treatments.

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, you will be informed about the trial's purpose, procedures, and your role as a participant. You will be asked to provide consent to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your current health status. This may include physical examinations, blood tests, and other necessary evaluations to ensure you meet the study's eligibility criteria.

  3. Step 3

    Treatment phase

    During the treatment phase, you will receive the study medications. You will take lenvatinib orally in the form of capsules. The dosage and frequency will be determined by the study team based on your specific needs.

    You will also receive pembrolizumab through an intravenous infusion. This means the medication will be administered directly into your vein. The frequency and duration of these infusions will be explained to you by the study team.

  4. Step 4

    Follow-up visits

    Regular follow-up visits will be scheduled to monitor your health and the effects of the treatment. These visits may include physical exams, blood tests, and other assessments as needed.

    The study team will check for any side effects or changes in your condition and adjust your treatment plan if necessary.

  5. Step 5

    End of treatment

    At the end of the treatment phase, a final assessment will be conducted to evaluate your overall health and the outcomes of the study treatment.

    You will be informed about any further steps or follow-up care that may be required after the study concludes.

Who can join the trial?

10 criteria

  • Must have been treated in previous studies with pembrolizumab, a type of cancer treatment.
  • Must be currently receiving pembrolizumab, pembrolizumab-based combinations, or lenvatinib, another cancer treatment, from previous studies or in a follow-up phase.
  • For women: Must not be pregnant or breastfeeding. If of childbearing potential, must use highly effective birth control methods or be abstinent from heterosexual intercourse during the study and for at least 4 days after.
  • For men: Must agree to be abstinent from penile-vaginal intercourse or use a highly effective contraceptive method while receiving the study drug and for 7 days after the last dose of lenvatinib.
  • Must have adequately controlled blood pressure, which means it should be less than 150/90 mmHg, with or without medication.
  • For the Second Course Phase only: Must not have received any other cancer treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in the First Course Phase.
  • For the Second Course Phase only: Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means being fully active or having some symptoms but nearly fully active.
  • For the Second Course Phase only: Must have adequate organ function, meaning the organs are working well enough to participate in the study.
  • For the Second Course Phase only: Must have recovered from any side effects of the First Course Phase treatment to a mild level (Grade 1 or less), except for hair loss. If major surgery or radiation therapy was received, must have recovered from any related side effects or complications.
  • For the Second Course Phase only: Female participants must agree to use contraception during the study treatment period and for at least 120 days after, which is the time needed to eliminate any study treatment effects plus 30 days for a menstrual cycle.

Who cannot join the trial?

4 criteria

  • Patients with **advanced tumors** cannot participate. Advanced tumors are cancers that have spread to other parts of the body.
  • Patients who are not within the specified age range cannot participate. The age range for this study is not specified here.
  • Patients who belong to certain clinical trial groups that are not specified here cannot participate.
  • Patients who are considered part of a **vulnerable population** cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.
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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. Normally, your immune system can recognize and attack cancer cells, but sometimes cancer cells find ways to hide from it. Pembrolizumab blocks a specific pathway that cancer cells use to avoid being attacked by the immune system. By blocking this pathway, pembrolizumab helps your immune system detect and destroy cancer cells more effectively. This medication is used in various types of cancer treatments and is being studied for its long-term safety and effectiveness in this trial.

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 being studied in a Phase 3 clinical trial to assess its long-term safety and effectiveness for patients with advanced tumors. The main therapeutic use of pembrolizumab is to help the immune system fight cancer by blocking a specific protein that prevents immune cells from attacking cancer cells. It belongs to a class of drugs known as immune checkpoint inhibitors, which enhance the body's natural defenses against cancer.

Investigated diseases

Advanced Tumors – Advanced tumors refer to cancerous growths that have progressed to a late stage, often spreading beyond their original site to other parts of the body. These tumors can originate in various organs and tissues, and their progression is characterized by the invasion of surrounding tissues and the potential to metastasize. As the disease advances, it may affect the function of the organs involved, leading to a range of symptoms depending on the location and size of the tumor. The growth of advanced tumors is typically aggressive, and they may continue to grow and spread if not managed. The progression of these tumors can lead to significant changes in the body's normal functioning, impacting overall health and quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501254-10-00Protocol codeMK-3475-587Estimated enrolment3 500 patientsSponsorMerck Sharp & Dohme LLC

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).