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Study on Niraparib and Dostarlimab for Patients with HPV-Negative Head and Neck Squamous Cell Carcinoma

Fast replyRegistered 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 a type of cancer called HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC). The study will use a combination of two treatments: Niraparib, which is a medication taken as a tablet, and Dostarlimab, which is given through an infusion into a vein. Niraparib is also known by its code name MK-4827, and Dostarlimab is sometimes referred to as TSR-042.

The purpose of the study is to evaluate how effective this combination of treatments is for patients with HNSCC. Participants in the study will receive these treatments over a period of time, and their progress will be monitored. The study will include an initial phase where the safety of the treatments is assessed, followed by a longer period where the effectiveness of the treatments is evaluated. This will involve regular check-ups and possibly imaging tests like MRI to see how the cancer responds to the treatment.

Throughout the study, the safety of the treatments will be closely monitored, especially after surgery, to ensure that any side effects are managed. The study will also look at how the cancer responds to the treatments and whether there are any changes in the cancer's genetic makeup. The goal is to understand better how these treatments can help manage HNSCC and improve outcomes for patients with this type of cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Induction phase

    During the induction phase, the patient will receive a combination of medications to prepare for further treatment. This phase involves the administration of niraparib and dostarlimab.

    Niraparib is provided in the form of 100 mg film-coated tablets, taken orally. The specific dosage and frequency will be determined by the healthcare provider based on individual patient needs.

    Dostarlimab is administered as a 500 mg concentrate for solution, given through an intravenous infusion. The frequency and duration of this treatment will also be specified by the healthcare provider.

  2. Step 2

    Surgery

    Following the induction phase, the patient will undergo surgery. The goal of the surgery is to remove the tumor and assess the response to the induction treatment.

    The surgical procedure will be evaluated for safety, focusing on potential complications such as bleeding, wound healing issues, infection, and the need for additional surgical interventions.

  3. Step 3

    Maintenance phase

    After surgery, the patient will enter the maintenance phase. This phase aims to prevent cancer recurrence and involves continued treatment with niraparib.

    Niraparib will be administered as 100 mg film-coated tablets, taken orally. The healthcare provider will determine the appropriate dosage and duration of this treatment.

  4. Step 4

    Follow-up and monitoring

    Throughout the trial, the patient's health and response to treatment will be closely monitored. This includes regular medical assessments and imaging tests to evaluate the effectiveness of the treatment and detect any signs of cancer recurrence.

    The follow-up period will extend for a specified duration after the completion of the maintenance phase, ensuring comprehensive monitoring of the patient's condition.

Who can join the trial?

11 criteria

  • The patient must have a type of cancer called squamous cell carcinoma in specific areas like the mouth, throat, or voice box, and it should be possible to remove it with surgery aimed at curing the disease.
  • For throat cancer, the cancer must be HPV-negative, which means it is not caused by the human papillomavirus. This is checked using a special test.
  • The cancer must be at a specific stage, known as stage III-IV(M0), which means it is advanced but has not spread to distant parts of the body. The patient should not have cancer that has come back or spread after previous treatments.
  • The patient must have a good general health status, known as performance status ECOG 0-1, which means they are fully active or have some symptoms but can still carry out light work.
  • The patient should not have another type of cancer, except for certain types that are not serious or have been completely treated at least two years ago.
  • The patient must have normal functioning of important organs and blood cells, which includes specific levels of blood components and kidney and liver function.
  • The patient must be able to swallow the medication used in the study.
  • The patient must agree not to donate blood during the study and for 90 days after the last dose of the study treatment.
  • If the patient is a woman who can have children, she must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for 180 days after the last dose. If she cannot have children, she must meet certain criteria, such as being of a certain age and not having periods for over a year, or having had surgery to remove reproductive organs.
  • The patient must agree not to breastfeed during the study and for 120 days after the last dose of the study treatment.
  • If the patient is a man, he must agree to use effective birth control during the study and for 180 days after the last dose. Abstinence is acceptable if it is the chosen method of contraception.

Who cannot join the trial?

4 criteria

  • Patients with **HPV-positive** Head and Neck Squamous Cell Carcinoma (HNSCC) cannot participate. **HPV** stands for Human Papillomavirus, a virus that can affect the skin and the moist membranes lining your body.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
  • Patients who are not part of the specified clinical trial groups cannot participate. Clinical trial groups are categories of patients that the study is focusing on.
  • Patients who are part of a vulnerable population may not be eligible. A **vulnerable population** includes groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

  • PARP Inhibitor

    is a type of medication that blocks an enzyme used by cells to repair damage to their DNA. In this trial, it is used to see if it can help treat head and neck squamous cell carcinoma by preventing cancer cells from repairing themselves, which may lead to their death.

  • Immunotherapy

    is a treatment that uses the body's own immune system to fight cancer. It helps the immune system recognize and attack cancer cells more effectively. In this trial, immunotherapy is combined with the PARP inhibitor to see if the combination is more effective in treating head and neck squamous cell carcinoma.

What is already known about the treatment

  • PARP Inhibitor

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC). It is primarily used in cancer treatment, where it works by blocking the PARP enzyme, which helps repair DNA damage in cells. By inhibiting this enzyme, the medication prevents cancer cells from repairing themselves, leading to their death. It is classified as a targeted cancer therapy.

  • Immunotherapy

    This treatment is typically given through intravenous infusion and is being evaluated in clinical trials for its role in managing HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC). Immunotherapy works by stimulating the body's immune system to recognize and attack cancer cells more effectively. It is part of a class of treatments known as biologic therapy, which enhances the body's natural defenses to fight cancer.

Investigated diseases

HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC) – This is a type of cancer that occurs in the squamous cells lining the head and neck region, excluding those associated with the human papillomavirus (HPV). It typically begins in the mucous membranes of the mouth, nose, or throat. The disease progresses as the cancer cells grow and form tumors, which can invade nearby tissues and spread to other parts of the body. Symptoms may include a persistent sore throat, difficulty swallowing, and changes in voice. As the disease advances, it can lead to more severe symptoms and complications. Early detection and monitoring are crucial for managing the progression of this cancer.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516798-54-00Estimated enrolment49 patientsSponsorFondazione GONO Plus

sourced from the EU Clinical Trials Register and site verification

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