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Study of Pembrolizumab and Olaparib for Adults with Recurrent or Metastatic, Platinum-Resistant Nasopharyngeal Cancer

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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 nasopharyngeal cancer, which affects the area behind the nose and above the back of the throat. The study is specifically looking at cases where the cancer has come back or spread to other parts of the body and is resistant to a common treatment known as platinum-based therapy. The trial will use two medications: pembrolizumab, which is given as an infusion into a vein, and olaparib, which is taken as a tablet by mouth. Pembrolizumab is an immunotherapy drug that helps the immune system fight cancer, while olaparib is a type of targeted therapy that interferes with the cancer cells' ability to repair themselves.

The purpose of the study is to see if the combination of pembrolizumab and olaparib can improve the response rate in patients compared to historical data where only immunotherapy was used. Participants in the study will receive these treatments over a period of up to 36 months. During this time, they will have regular check-ups and assessments to monitor their health and the cancer's response to the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual drugs.

The study will also look at how long patients live without the cancer getting worse, known as progression-free survival, and overall survival, which is the time from the start of treatment until death from any cause. Additionally, the study will assess any side effects experienced by participants and changes in their quality of life using a specific questionnaire designed for head and neck cancer patients. The trial aims to provide valuable information that could lead to better treatment options for people with recurrent or metastatic nasopharyngeal cancer.

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 study, an initial assessment will be conducted to confirm eligibility. This includes a review of medical history, a physical examination, and necessary laboratory tests to ensure adequate organ function.

    The assessment will also involve confirming a diagnosis of nasopharyngeal carcinoma and evaluating the disease's progression.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of pembrolizumab through an intravenous infusion. This is a solution that will be given directly into a vein.

    Following the infusion, olaparib will be taken orally in the form of film-coated tablets. The specific dosage and frequency will be provided by the healthcare team.

  3. Step 3

    Ongoing treatment

    The treatment with pembrolizumab and olaparib will continue as per the schedule provided by the healthcare team. Regular monitoring will be conducted to assess the response to the treatment.

    Patients will be required to attend scheduled visits for follow-up assessments, which may include physical exams, imaging tests, and laboratory tests.

  4. Step 4

    Response evaluation

    The primary goal is to evaluate the objective response rate by the third radiological examination, approximately 27 weeks into the study. This involves assessing the size and number of cancer lesions.

    The response will be classified as either a complete response, where all target lesions disappear, or a partial response, where there is a significant reduction in the size of the lesions.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, the occurrence of any adverse events will be monitored and recorded. This includes any side effects experienced during the treatment.

    The study will also track progression-free survival and overall survival, which are measures of how long patients live without the disease worsening and overall survival time, respectively.

  6. Step 6

    Quality of life assessment

    Changes in quality of life will be evaluated using a specific questionnaire designed for patients with head and neck cancer. This will help understand the impact of the treatment on daily living and well-being.

Who can join the trial?

10 criteria

  • Participants must be male or female and at least 18 years old.
  • Participants must have adequate organ function. This means their organs are working well enough to participate in the study. Tests will be done within 10 days before starting the study treatment to check this.
  • Participants (or their legally acceptable representative) must provide written informed consent. This means they agree to participate in the study after being informed about it.
  • Participants must have a confirmed diagnosis of nasopharyngeal carcinoma. This is a type of cancer that affects the area behind the nose and above the back of the throat.
  • The disease must not be treatable with surgery or radiation with the goal of curing it.
  • The disease must have progressed within 6 months after previous treatment with platinum-based drugs, which are a type of chemotherapy.
  • Male participants must agree to use contraception during the treatment and for at least 6 months after the last dose. They should also not donate sperm during this time. Female partners of male participants should also use a highly effective form of contraception if they can become pregnant. Female participants must not be pregnant or breastfeeding and must agree to use contraception if they can become pregnant.
  • Participants must have measurable disease based on specific criteria (RECIST 1.1). This means the cancer can be measured using medical imaging tests. If the cancer was previously treated with radiation, it can still be measured if it has grown since then.
  • Participants must have an ECOG performance status of 0 to 1. This is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, and 1 means some restrictions but still able to do light work.
  • Participants must have a life expectancy of at least 16 weeks.

Who cannot join the trial?

9 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not previously been treated with platinum-based chemotherapy.
  • Patients who are currently receiving another form of cancer treatment.
  • Patients with serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of severe allergic reactions to the study medication.
  • Patients who are unable to follow the study procedures.
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Investigated drugs

  • Pembrolizumab

    is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, pembrolizumab is used to treat nasopharyngeal cancer that has come back or spread to other parts of the body and is resistant to platinum-based treatments.

  • Olaparib

    is a medication that targets cancer cells by interfering with their ability to repair themselves. It belongs to a class of drugs called PARP inhibitors. In this trial, olaparib is used in combination with pembrolizumab to see if it can improve the response rate in treating nasopharyngeal cancer.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into a vein through a drip. It is currently used in medicine to treat various types of cancer, and medical literature supports its role in enhancing the immune system's ability to fight cancer cells. The main therapeutic indication for pembrolizumab in this trial is for adult patients with recurrent or metastatic nasopharyngeal cancer that is resistant to platinum-based chemotherapy. At the molecular level, pembrolizumab works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor in pharmacology.

  • Olaparib

    Olaparib is taken orally in the form of tablets or capsules. It is currently recognized in medicine for its use in treating certain types of cancers, particularly those with specific genetic mutations. In this clinical trial, olaparib is used for adult patients with recurrent or metastatic nasopharyngeal cancer that does not respond to platinum-based treatments. Olaparib works at the molecular level by inhibiting an enzyme called PARP, which helps repair DNA damage in cells. By blocking this enzyme, olaparib prevents cancer cells from repairing themselves, leading to their death. It is classified as a PARP inhibitor in pharmacology.

Investigated diseases

Nasopharyngeal Cancer – Nasopharyngeal cancer is a type of cancer that occurs in the nasopharynx, which is the upper part of the throat behind the nose. It often begins in the squamous cells that line the nasopharynx. The disease can progress by spreading to nearby tissues and lymph nodes. As it advances, it may cause symptoms such as nasal congestion, nosebleeds, and hearing loss. The cancer can also metastasize to other parts of the body, such as the bones or lungs. The progression of nasopharyngeal cancer is typically monitored through imaging studies and clinical evaluations.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511901-52-00Protocol codePOINTEstimated enrolment30 patientsSponsorFondazione GONO Plus

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