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Study of Pembrolizumab, Epacadostat, and Drug Combination for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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 Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma, a type of cancer that occurs in the head and neck region and has returned or spread to other parts of the body. The study will evaluate the effectiveness and safety of three different treatment approaches: a combination of Pembrolizumab and Epacadostat, Pembrolizumab alone, and a treatment regimen known as the EXTREME regimen. Pembrolizumab, also known by its code name MK-3475, is a medication that helps the immune system fight cancer cells. Epacadostat, with the code name INCB024360, is a drug that may enhance the effects of Pembrolizumab.

The purpose of the study is to assess how well these treatments work in managing the cancer and to monitor their safety. Participants will receive one of the treatments and will be monitored over a period of time to see how their cancer responds. The study will also track any side effects experienced by participants to ensure the treatments are safe. The EXTREME regimen is a combination of chemotherapy drugs, including Cetuximab, Cisplatin, and Fluorouracil, which are commonly used to treat this type of cancer.

Throughout the study, participants will receive regular check-ups and assessments to monitor their health and the progress of their treatment. The study aims to provide valuable information on the best treatment options for patients with this type of cancer, helping to improve future care and outcomes. Participants may receive a placebo, which is a substance with no active medication, as part of the study design to compare the effects of the actual treatments.

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 will be assigned to one of three treatment groups. The assignment is random and aims to compare different treatment approaches for head and neck cancer.

  2. Step 2

    Treatment group 1: pembrolizumab and epacadostat

    Participants in this group will receive pembrolizumab and epacadostat.

    Pembrolizumab is administered as an intravenous infusion. This means it is given directly into a vein through a drip. The infusion is typically done every three weeks.

    Epacadostat is taken orally in the form of tablets. The dosage and frequency will be specified by the study team.

  3. Step 3

    Treatment group 2: pembrolizumab monotherapy

    Participants in this group will receive pembrolizumab alone.

    Pembrolizumab is administered as an intravenous infusion every three weeks.

  4. Step 4

    Treatment group 3: the extreme regimen

    Participants in this group will receive a combination of treatments known as the EXTREME regimen.

    This includes pembrolizumab, fluorouracil, and carboplatin, all administered as intravenous infusions.

    The specific schedule and dosage will be provided by the study team.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, participants will undergo regular monitoring to assess the effectiveness and safety of the treatment.

    This includes medical examinations, imaging tests, and laboratory tests.

    Participants will be asked to report any side effects or changes in their condition.

  6. Step 6

    Completion of the study

    The study is expected to conclude by December 27, 2024.

    Upon completion, participants will have a final assessment to evaluate the overall outcomes of the treatment.

Who can join the trial?

7 criteria

  • Participants must have a type of cancer called recurrent or metastatic head and neck squamous cell carcinoma that cannot be cured with local treatments. The cancer must be located in the oropharynx, oral cavity, hypopharynx, or larynx.
  • The cancer must be measurable according to specific guidelines known as RECIST v1.1, which are used to assess how well the cancer responds to treatment.
  • Participants should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Participants must have adequate organ function as defined by the study's specific criteria.
  • Participants need to have documentation of their human papilloma virus (HPV) status if they have oropharyngeal cancer. HPV is a virus that can affect certain types of cancer.
  • Participants must have a tumor sample available from a previous biopsy or be willing to undergo a new biopsy to obtain a sample from a tumor that has not been treated with radiation before the study.
  • Both male and female participants are eligible for the study.

Who cannot join the trial?

3 criteria

  • Patients with a type of cancer called Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma that cannot be cured by local treatments.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Pembrolizumab

    is a medication used in this trial to help the immune system fight cancer. It works by blocking a specific protein on cancer cells, allowing the immune system to better identify and attack these cells. In this study, it is used both alone and in combination with another medication.

  • Epacadostat

    is another medication used in combination with pembrolizumab in this trial. It works by inhibiting an enzyme that helps cancer cells evade the immune system. By blocking this enzyme, epacadostat may enhance the effectiveness of pembrolizumab in attacking cancer cells.

  • EXTREME Regimen

    is a combination of chemotherapy drugs used as a standard treatment for certain types of cancer. It typically includes a mix of medications that work together to kill cancer cells or stop them from growing. In this trial, it is used as a comparison to evaluate the effectiveness of the other treatments.

What is already known about the treatment

  • Pembrolizumab

    This medication is administered intravenously and is currently used in clinical settings for treating certain types of cancer. It is approved for use in recurrent or metastatic head and neck squamous cell carcinoma that cannot be cured by local therapies. Pembrolizumab works by blocking a specific protein on immune cells, allowing them to better attack cancer cells. It is classified as an immune checkpoint inhibitor.

  • Epacadostat

    This medication is taken orally and is being studied in clinical trials for its potential use in cancer treatment. It is being evaluated for its effectiveness in combination with pembrolizumab for head and neck squamous cell carcinoma. Epacadostat works by inhibiting an enzyme that suppresses the immune system, thereby enhancing the body's ability to fight cancer. It is classified as an enzyme inhibitor.

Investigated diseases

Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma – This is a type of cancer that originates in the squamous cells lining the head and neck region. It is characterized by its recurrence or spread to other parts of the body, making it challenging to treat with localized therapies. The disease often progresses by invading nearby tissues and can metastasize to distant organs. Symptoms may include persistent sore throat, difficulty swallowing, and changes in voice. As the disease advances, it may lead to noticeable lumps or sores that do not heal. The progression can vary, but it typically involves a gradual worsening of symptoms and increased difficulty in managing the condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512015-47-00Protocol codeMK-3475-669Estimated enrolment42 patientsSponsorIncyte Corp.

sourced from the EU Clinical Trials Register and site verification

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