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Study of pembrolizumab and vorinostat combination therapy in patients with recurrent or metastatic squamous cell carcinoma of head and neck, cervix, anus, and genital areas

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 study focuses on several types of squamous cell carcinoma that have spread or returned after previous treatment, including cancers of the head and neck, cervix, anus, vulva/vagina, and penis. The study tests a combination of two medications: pembrolizumab, which is given through an intravenous injection, and vorinostat, which is taken as an oral capsule. The purpose is to evaluate how well these medications work together in treating these types of cancer.

The treatment involves receiving pembrolizumab as an infusion at a dose of up to 200 mg, along with vorinostat capsules at a dose of up to 400 mg daily. The treatment period may continue for up to 105 weeks. During the study, doctors will monitor how the cancer responds to the treatment combination through regular medical examinations and imaging tests.

Both medications work differently to fight cancer. Pembrolizumab is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. Vorinostat belongs to a group of medications that work by affecting how genes behave in cancer cells. This combination approach aims to provide better results than using either medication alone.

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

    Initial phase

    Your participation begins after signing the informed consent form

    Medical staff will confirm if you meet health requirements, including adequate bone marrow function, liver function, and kidney function

    A tumor biopsy will be performed to confirm the diagnosis

  2. Step 2

    Treatment administration

    You will receive two medications:

    Pembrolizumab (Keytruda) - given through an intravenous injection

    Vorinostat - taken as oral capsules

    Regular blood samples will be collected throughout the treatment

  3. Step 3

    Monitoring phase

    Your tumor response will be measured regularly using imaging scans

    Medical staff will monitor any side effects using a standardized assessment system

    The effectiveness of treatment will be evaluated based on whether the tumor shrinks (complete or partial response) or remains stable

  4. Step 4

    Follow-up period

    After completing treatment, you will need to use effective contraception for 6 months

    Regular check-ups will continue to monitor your health status

    The study is expected to continue until November 2024

  5. Step 5

    Safety requirements

    You must inform medical staff about any new symptoms or health changes

    Regular attendance at scheduled visits is required

    You must be able to swallow oral medications

    You must maintain the contraception requirements throughout the study period

Who can join the trial?

17 criteria

  • Must be 18 years or older
  • Have adequate bone marrow function, which means: - Normal white blood cell count (at least 1,500/mm³) - Normal platelet count (at least 100,000/mm³) - Adequate hemoglobin levels (at least 9 g/dL)
  • Have normal blood clotting function
  • Female participants who can become pregnant must have a negative pregnancy test within 72 hours before starting treatment
  • Female participants must use highly effective birth control during the study and for 4 months after the last pembrolizumab dose and 6 months after the last vorinostat dose
  • Male participants must use effective birth control during the study and for 4 months after the last pembrolizumab dose and 6 months after the last vorinostat dose
  • Must be able to follow the study schedule, including appointments and laboratory tests
  • Must agree to tumor biopsy and blood samples throughout the study
  • Must be able to swallow medications
  • Must have health insurance or equivalent coverage
  • Must sign an informed consent form
  • Must have good physical function status (ECOG score of 0 or 1, meaning able to perform daily activities)
  • Must have confirmed squamous cell carcinoma that has returned or spread
  • Must have disease that can be measured and biopsied
  • Can be either newly diagnosed or previously treated
  • Must have normal kidney function
  • Must have adequate liver function tests

Who cannot join the trial?

14 criteria

  • History of treatment with pembrolizumab (a type of immunotherapy drug) or vorinostat (a medication that affects gene expression)
  • Active autoimmune disease (a condition where the immune system attacks healthy cells) that requires systemic treatment
  • History of severe allergic reactions to monoclonal antibody treatments
  • Untreated brain metastases (cancer that has spread to the brain)
  • Active infection requiring systemic therapy
  • Known active Hepatitis B or C infection
  • Known history of HIV infection
  • Use of systemic corticosteroids or other immunosuppressive medication within 7 days before starting the study treatment
  • Participation in another clinical trial within 4 weeks before starting this study
  • Pregnant or breastfeeding women
  • Significant heart conditions within the past 6 months
  • Any condition that could interfere with the interpretation of study results
  • Unable to swallow oral medications
  • Known psychiatric or substance abuse disorders that would interfere with study participation
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Investigated drugs

Pembrolizumab is a type of immunotherapy medication that helps the body's immune system recognize and fight cancer cells. It works by blocking a protein called PD-1, which normally prevents T-cells (immune cells) from attacking cancer cells. By blocking this protein, pembrolizumab allows the immune system to work more effectively against cancer. Vorinostat is a medication that belongs to a group of drugs called histone deacetylase (HDAC) inhibitors. It works by helping to control the way genes are expressed in cancer cells, which can slow down or stop cancer cell growth. It may also make cancer cells more visible to the immune system, potentially making other cancer treatments work better. These medications are used together to treat various types of squamous cell carcinoma, which is a type of cancer that develops in the flat cells that line certain organs and tissues in the body.

What is already known about the treatment

  • Pembrolizumab

    An immunotherapy medication administered through intravenous infusion that belongs to the class of PD-1 inhibitors. This prescription drug works by helping the immune system detect and fight cancer cells by blocking the PD-1 pathway that cancer cells use to hide from immune cells. It is currently approved for treating various types of squamous cell carcinomas, including head and neck, cervical, and other advanced cancers, showing significant effectiveness in clinical practice.

  • Vorinostat

    An oral medication belonging to the histone deacetylase (HDAC) inhibitor class, taken as a capsule. This drug works at the molecular level by preventing the removal of acetyl groups from histones, thereby regulating gene expression and potentially stopping cancer cell growth. It is primarily used in the treatment of various types of cancer, particularly showing promise in combination therapy with immunotherapy drugs for treating advanced squamous cell carcinomas.

Investigated diseases

  • Squamous Cell Carcinoma of Vulva/Vagina

    A type of skin cancer that develops in the cells of the outer layer of the vulvar or vaginal tissue. The disease begins in the squamous cells, which are the main type of skin cells, and typically grows slowly over time.

  • Squamous Cell Carcinoma of the Head and Neck

    A cancer that starts in the flat surface cells lining the inside of the head and neck regions, including the mouth, nose, throat, and voice box. It typically develops gradually in the mucous membranes of these areas.

  • Squamous Cell Carcinoma of Penis

    A cancer that forms in the skin cells of the penis, usually starting on the foreskin or glans. The disease develops in the squamous cells of the penis and tends to progress slowly.

  • Squamous Cell Carcinoma of Cervix

    A cancer that develops from the squamous cells in the cervix, which is the lower part of the uterus. The disease typically develops gradually, starting with changes in the cervical cells.

  • Squamous Cell Carcinoma of Anus

    A cancer that begins in the squamous cells lining the anal canal and anal margin. The disease develops in the outer layer of skin cells in the anal area and usually progresses slowly.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510320-71-00Protocol codeUC-GMP-1908Estimated enrolment112 patientsSponsorUnicancer

sourced from the EU Clinical Trials Register and site verification

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