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Study on Reduced Dose Intensity of Pembrolizumab and Drug Combination for Patients with Advanced or Metastatic Cancer Responding to Standard Immunotherapy

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 various types of cancer, including lung cancer, kidney cancer, head and neck cancer, bladder cancer, triple-negative breast cancer, Merkel cell cancer, melanoma, liver cancer, colorectal cancer with a specific genetic feature called microsatellite instability, esophageal cancer, endometrial cancer, cervical cancer, stomach cancer, and certain types of skin cancer. The study involves patients whose cancer is either locally advanced or has spread to other parts of the body, and who have shown a positive response after six months of standard treatment with immunotherapy. Immunotherapy is a type of treatment that helps the immune system fight cancer.

The purpose of this study is to compare the effects of continuing standard immunotherapy with a reduced dose of the same treatment. The medications being studied include Pembrolizumab, Durvalumab, Avelumab, Nivolumab, Dostarlimab, Atezolizumab, and Cemiplimab. These medications are given through an intravenous infusion, which means they are administered directly into the bloodstream through a vein. Some patients will receive the standard dose of these medications, while others will receive a reduced dose every three months.

The study will last for up to three years, during which time patients will continue to receive their assigned treatment. The main goal is to see if the reduced dose is as effective as the standard dose in keeping the cancer from getting worse. Patients will have regular check-ups and assessments to monitor their health and the progress of their cancer. The study will also look at other factors, such as the quality of life and any side effects experienced by the patients. This research aims to find the best way to use immunotherapy to treat cancer effectively while minimizing side effects.

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, the patient must have signed a written informed consent form. This is a document that confirms understanding and agreement to participate in the trial.

    The patient must meet specific criteria, such as being at least 18 years old, having a confirmed diagnosis of certain types of cancer, and being in partial or complete response after 6 months of standard immunotherapy.

  2. Step 2

    Randomization

    The patient will be randomly assigned to one of two groups: one receiving standard immunotherapy and the other receiving a reduced dose intensity of the same immunotherapy.

    This process ensures that the study results are unbiased and reliable.

  3. Step 3

    Treatment administration

    The patient will receive immunotherapy through intravenous use. The specific medication could be one of several options, such as pembrolizumab, durvalumab, or nivolumab, among others.

    The frequency of administration will depend on the group assignment: standard administration or every three months for the reduced dose group.

  4. Step 4

    Scheduled visits and assessments

    The patient will attend regular visits to monitor health and response to treatment. These visits will include examinations and possibly imaging tests to assess the cancer's status.

    The patient's quality of life and any side effects will be evaluated using questionnaires and clinical assessments.

  5. Step 5

    Follow-up

    The patient will continue to be monitored for progression-free survival, which is the time from randomization until the cancer progresses or the patient passes away.

    Additional follow-up assessments will occur at various intervals, such as 12 and 24 months post-randomization, to evaluate overall survival and other health outcomes.

Who can join the trial?

13 criteria

  • Patients must have signed a written informed consent form before any trial-specific procedures.
  • Patients must show evidence of being post-menopausal or have a negative pregnancy test if they are premenopausal.
  • Both sexually active women who can have children and men (and their female partners) must agree to use a reliable method of birth control during the study and after completing treatment.
  • Patients must be willing and able to follow the study rules, including attending treatment sessions, scheduled visits, and examinations.
  • Patients must be part of a Social Security System.
  • Patients must be 18 years old or older.
  • Patients must have a type of cancer that is either metastatic (spread to other parts of the body) or locally advanced (grown too much to be treated locally). This includes specific types of cancer like lung cancer, kidney cancer, head and neck cancer, and others listed.
  • Patients must be in partial or complete response after 6 months of standard immunotherapy treatment. For melanoma, only those in partial response are eligible. This response must be confirmed by a local radiological assessment.
  • Patients must be eligible to continue the same standard immunotherapy treatment.
  • Patients must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • Patients with brain metastases (cancer spread to the brain) are allowed if they are stable, meaning they have been treated and show no signs of getting worse.
  • Patients who have previously received immunotherapy combined with chemotherapy are allowed.
  • Patients treated with specific combinations of drugs like TKI-IO, pemetrexed-IO, or bevacizumab-IO are allowed.

Who cannot join the trial?

4 criteria

  • Patients who have not been diagnosed with a specific type of cancer, such as lung cancer, kidney cancer, head and neck cancer, bladder cancer, a certain type of breast cancer, Merkel cell cancer, skin cancer, liver cancer, colon cancer with a specific genetic feature, esophageal cancer, uterine cancer, cervical cancer, stomach cancer, or certain types of skin cancer.
  • Patients who have not shown a partial or complete response to treatment after 6 months of standard immunotherapy. Immunotherapy is a type of treatment that helps your immune system fight cancer.
  • Patients with melanoma who have not shown a partial response to treatment. Melanoma is a type of skin cancer.
  • Patients who have been treated with a combination of certain drugs and have not shown a response. These drugs include ipilimumab, pemetrexed, bevacizumab, or Tyrosine Kinase Inhibitors (TKI). These are specific types of cancer treatments.
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Investigated drugs

  • Checkpoint Inhibitors

    are a type of immunotherapy used in this trial. They work by helping the immune system recognize and attack cancer cells more effectively. These medications block certain proteins made by some types of immune system cells, such as T cells, and some cancer cells. This blocking action helps the immune system destroy cancer cells. In this trial, checkpoint inhibitors are used as a standard treatment for patients with locally advanced or metastatic cancer.

  • Reduced Dose Intensity of Checkpoint Inhibitors

    is another approach being tested in this trial. After patients have been on standard checkpoint inhibitors for six months and have shown a response, the trial explores whether a lower dose of these inhibitors can maintain the same effectiveness in controlling the cancer. This approach aims to reduce potential side effects while still providing the benefits of immunotherapy.

What is already known about the treatment

Checkpoint Inhibitors – These medications are typically administered intravenously and are used in the treatment of various advanced or metastatic cancers. They are currently well-established in medical literature and are a standard part of cancer therapy. The main therapeutic indications include lung cancer, renal cell cancer, head and neck cancer, urothelial carcinoma, and several other types of cancer. At the molecular level, checkpoint inhibitors work by blocking proteins that prevent the immune system from attacking cancer cells, thereby enhancing the body's immune response against tumors. They are classified as immunotherapy agents.

Investigated diseases

  • Lung Cancer

    A disease characterized by uncontrolled cell growth in the tissues of the lung. It often begins in the cells lining the bronchi and parts of the lung such as the bronchioles or alveoli. As it progresses, it can spread to other parts of the body, including the lymph nodes and brain. Symptoms may include persistent cough, chest pain, and shortness of breath. The disease can be classified into small cell lung cancer and non-small cell lung cancer, each with different growth patterns.

  • Renal Cell Carcinoma

    A type of kidney cancer that originates in the lining of the proximal convoluted tubule. It is the most common type of kidney cancer in adults. The disease may initially present with symptoms such as blood in the urine, flank pain, and a mass in the abdomen. As it progresses, it can spread to nearby tissues and distant organs. The cancer cells can grow into a large mass and may invade the renal vein or spread to the lungs and bones.

  • Head and Neck Cancer

    A group of cancers that originate in the squamous cells lining the moist surfaces inside the head and neck. These cancers can affect areas such as the mouth, throat, and larynx. Symptoms may include a lump or sore that does not heal, a persistent sore throat, and difficulty swallowing. As the disease progresses, it can spread to lymph nodes and other parts of the body. Risk factors include tobacco use, alcohol consumption, and human papillomavirus (HPV) infection.

  • Urothelial Carcinoma

    A cancer that occurs in the urothelial cells lining the bladder, ureters, and other parts of the urinary tract. It is the most common type of bladder cancer. Symptoms may include blood in the urine, frequent urination, and pain during urination. As it progresses, it can invade the bladder wall and spread to nearby lymph nodes and organs. The disease is often linked to smoking and exposure to certain industrial chemicals.

  • Triple Negative Breast Cancer

    A subtype of breast cancer that lacks estrogen, progesterone, and HER2 receptors. It tends to be more aggressive and has fewer treatment options compared to other breast cancer types. Symptoms may include a lump in the breast, changes in breast shape, and skin dimpling. The cancer can spread to other parts of the body, including the lymph nodes and lungs. It is more common in younger women and those with a BRCA1 gene mutation.

  • Merkel Cell Carcinoma

    A rare and aggressive skin cancer that originates in the Merkel cells located in the skin. It often appears as a painless, fast-growing nodule on sun-exposed areas of the skin. The disease can quickly spread to nearby lymph nodes and distant organs. Risk factors include excessive sun exposure, a weakened immune system, and infection with the Merkel cell polyomavirus. Early detection is crucial due to its rapid progression.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513707-14-00Protocol codeUC-IMM-2101Estimated enrolment646 patientsSponsorUnicancer

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