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Study of Pembrolizumab for Patients with Advanced Solid Tumors

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 the effects of a medication called pembrolizumab, also known by its code name MK-3475, on various types of advanced solid tumors. These tumors include Anal Squamous Cell Carcinoma, Biliary Adenocarcinoma, Neuroendocrine Tumors, Endometrial Carcinoma, Cervical Squamous Cell Carcinoma, Vulvar Squamous Cell Carcinoma, Small Cell Lung Carcinoma, Mesothelioma, Thyroid Carcinoma, and Salivary Gland Carcinoma. The study also includes any advanced solid tumor that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as well as tumors with a high Tumor Mutational Burden (TMB-H).

The purpose of the study is to evaluate how well pembrolizumab works in treating these advanced tumors. Participants will receive the medication through an intravenous infusion, which means it is given directly into a vein. The study will monitor the response of the tumors to the treatment over time. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects. The study will last for a period of up to 24 months, during which the participants' health and tumor response will be closely observed.

The trial aims to understand the effectiveness of pembrolizumab by looking at how the tumors respond, how long the response lasts, and the overall survival of the participants. It will also track any side effects experienced by the participants. This information will help determine the potential benefits and risks of using pembrolizumab for treating these types of advanced solid tumors.

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

    Initial assessment

    Upon joining the clinical trial, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

    A physical examination and various tests may be performed to ensure all criteria are met for participation in the study.

  2. Step 2

    Treatment plan discussion

    The treatment plan is explained, including the use of the medication pembrolizumab, also known as KEYTRUDA.

    The method of administration is through an intravenous infusion, which means the medication is given directly into a vein.

  3. Step 3

    Medication administration

    The medication pembrolizumab is administered as a solution for infusion. The dosage is determined by the healthcare team based on individual needs.

    The frequency and duration of administration are specified by the study protocol and will be communicated by the healthcare provider.

  4. Step 4

    Regular monitoring

    Regular monitoring is conducted to assess the response to the treatment. This includes scheduled visits for physical examinations and tests.

    The healthcare team will monitor for any side effects or adverse reactions to the medication.

  5. Step 5

    Follow-up assessments

    Follow-up assessments are performed to evaluate the effectiveness of the treatment and to make any necessary adjustments.

    These assessments may include imaging studies and laboratory tests to track the progress of the condition.

  6. Step 6

    Completion of trial participation

    Upon completion of the trial, a final assessment is conducted to gather data on the overall response to the treatment.

    Participants may receive information on further treatment options or recommendations based on the trial outcomes.

Who can join the trial?

8 criteria

  • Have a confirmed diagnosis of an advanced solid tumor, which includes specific types like Anal Squamous Cell Carcinoma, Biliary Adenocarcinoma, Neuroendocrine Tumors, Endometrial Carcinoma, Cervical Squamous Cell Carcinoma, Vulvar Squamous Cell Carcinoma, Small Cell Lung Carcinoma, Mesothelioma, Thyroid Carcinoma, Salivary Gland Carcinoma, or any advanced solid tumor with certain genetic features.
  • The tumor must have progressed or the patient must not tolerate therapies that are known to help. There is no limit to how many treatments the patient has tried before.
  • Must be able to provide a sample of the tumor tissue for study purposes, depending on the type of tumor.
  • Have a disease that can be measured using radiology (imaging tests).
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale, which means the patient is fully active or has some symptoms but does not need bed rest.
  • Have a life expectancy of at least 3 months.
  • Have adequate organ function, meaning the organs are working well enough to participate in the study.
  • Female participants who can have children must agree to use effective birth control during the study and for a certain period after the last dose of the study drug. They must also agree not to donate eggs during this time.

Who cannot join the trial?

5 criteria

  • Patients with any type of cancer not listed in the study's specific cancer types.
  • Patients with colorectal cancer that is not classified as microsatellite instability-high (MSI-H). This means the cancer cells have a high number of genetic changes.
  • Patients with tumors that are not mismatch repair deficient (dMMR) or MSI-H in subjects from mainland China who are of Chinese descent. This refers to tumors with specific genetic characteristics.
  • Patients with tumors that have not failed at least one line of therapy and are not classified as Tumor Mutational Burden-High (TMB-H). This means the tumor has a high number of mutations.
  • Patients with tumors that are both dMMR and MSI-H are excluded from certain parts of the study.
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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. Pembrolizumab targets a specific protein on the surface of cancer cells called PD-1. By blocking this protein, pembrolizumab helps your immune system recognize and attack cancer cells more effectively. This medication is used in the trial to see how well it works in treating different types of advanced solid tumors, which are cancers that have spread or cannot be removed by surgery. The trial is also looking at how certain biomarkers, which are characteristics of the cancer, might predict how well pembrolizumab works for different patients.

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 clinical trials for its effectiveness in treating various advanced solid tumors, including anal squamous cell carcinoma, biliary adenocarcinoma, neuroendocrine tumors, endometrial carcinoma, cervical squamous cell carcinoma, vulvar squamous cell carcinoma, small cell lung carcinoma, mesothelioma, thyroid carcinoma, and salivary gland carcinoma, among others. The medication works by blocking a specific protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more effectively. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.

Investigated diseases

  • Anal Squamous Cell Carcinoma

    This is a type of cancer that forms in the tissues of the anus. It typically begins in the squamous cells, which are flat cells lining the anus. The disease may start as a small growth or sore that does not heal. Over time, it can invade deeper layers of tissue and spread to nearby lymph nodes. As it progresses, it may cause symptoms such as bleeding, pain, or changes in bowel habits. The progression can vary, with some cases remaining localized while others spread to distant organs.

  • Biliary Adenocarcinoma

    This cancer originates in the bile ducts or gallbladder. It begins in the glandular cells that line these structures. The disease often progresses slowly, initially causing few symptoms. As it advances, it can block bile ducts, leading to jaundice, abdominal pain, and weight loss. The cancer may spread to nearby organs and lymph nodes. Over time, it can become more aggressive and difficult to manage.

  • Neuroendocrine Tumors

    These tumors develop from neuroendocrine cells, which have traits of both nerve and hormone-producing cells. They can occur in various organs, including the lungs, pancreas, and gastrointestinal tract. The progression is often slow, and symptoms may not appear until the tumor is large or has spread. Symptoms depend on the tumor's location and may include pain, hormonal imbalances, or digestive issues. Some tumors may produce hormones, leading to specific syndromes. The disease can remain stable for years or become aggressive and spread to other parts of the body.

  • Endometrial Carcinoma

    This cancer forms in the lining of the uterus, known as the endometrium. It typically begins as a localized growth and can cause symptoms like abnormal vaginal bleeding. As it progresses, it may invade the muscular wall of the uterus and spread to nearby tissues. The disease can extend to the cervix, ovaries, and lymph nodes. In advanced stages, it may metastasize to distant organs. The progression rate can vary, with some cases remaining confined to the uterus for a long time.

  • Cervical Squamous Cell Carcinoma

    This cancer arises from the squamous cells on the surface of the cervix. It often begins as a precancerous condition called dysplasia, which can progress to invasive cancer. The disease may cause symptoms such as abnormal vaginal bleeding or discharge. As it advances, it can invade deeper cervical tissues and spread to nearby structures. The cancer may extend to the pelvic lymph nodes and beyond. The progression can be slow, allowing for early detection and intervention.

  • Vulvar Squamous Cell Carcinoma

    This cancer develops in the squamous cells of the vulva, the external part of the female genitalia. It often starts as a precancerous lesion that can progress to invasive cancer. Symptoms may include itching, pain, or a visible lump. As the disease advances, it can invade deeper tissues and spread to nearby lymph nodes. The cancer may extend to the urethra, vagina, or anus. The progression can vary, with some cases remaining localized for extended periods.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501253-37-00Protocol codeMK-3475-158Estimated enrolment1 709 patientsSponsorMerck Sharp & Dohme LLC

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