Ongoing Clinical Trials for Nasopharyngeal Cancer
There are currently 4 clinical trials investigating new treatments for nasopharyngeal cancer. These studies are testing immunotherapy medications, advanced imaging techniques, and combination therapies for patients whose cancer has not responded to standard platinum-based chemotherapy or has returned after treatment. Trials are taking place in the Netherlands, Poland, Germany, and Italy.
Clinical trial locations
- Germany
- Italy
- Netherlands
- Poland
Evaluating Somatostatin Receptor 2 Expression Using [68Ga]Ga-DOTA-TOC PET/CT Imaging in Patients with Epstein-Barr Virus Associated Nasopharyngeal Carcinoma
This study, taking place in the Netherlands, focuses on using advanced imaging to better understand cancer characteristics in patients whose disease is linked to the Epstein-Barr virus. The trial uses a special type of PET/CT scan with a radioactive tracer called [68Ga]Ga-DOTA-TOC to see if cancer cells have specific receptors called somatostatin receptor 2.
Who can participate: You may be eligible if you are at least 18 years old and have been diagnosed with stage IB-IVA disease that is positive for Epstein-Barr virus. Your cancer must be confirmed through EBER testing, and you must be scheduled to receive either induction chemotherapy or chemoradiation therapy. Previous tumor tissue samples must be available for laboratory testing. If you are a woman of childbearing potential, you must have a negative pregnancy test during screening.
Who cannot participate: You cannot join if you have ever had an allergic reaction to octreotide or the imaging agent used in the PET scan. The study excludes pregnant or breastfeeding women. You are not eligible if you have severe kidney problems, specifically if your glomerular filtration rate is less than 30 mL/min/1.73m². Other exclusions include having a medical condition that prevents you from lying still for 30-60 minutes during the scan, receiving radiation therapy or chemotherapy within 2 weeks before the study starts, having other active cancers requiring treatment (except non-melanoma skin cancer), uncontrolled diabetes, or taking medications that interfere with the imaging agent.
What the trial involves: The main goal is to determine if this imaging technique can effectively assess tumor characteristics. Participants will undergo two PET/CT scans: one before starting cancer treatment and one after completing either induction chemotherapy or chemoradiotherapy. The scans will help researchers compare how the tumor and its receptors change with treatment. Your tumor tissue will also be analyzed in the laboratory to measure actual receptor levels and compare them with what the scans show.
Investigational agent: The imaging tracer [68Ga]Ga-DOTA-TOC is a radioactive substance that binds to somatostatin receptors on cancer cells. It helps doctors visualize the cancer more clearly and determine if certain targeted treatments might be effective in the future.
Study of nivolumab treatment for patients with nasopharyngeal cancer who did not respond to or worsened after platinum chemotherapy
This clinical trial in Poland is testing Nivolumab, an immunotherapy medication, for patients whose cancer did not respond to or worsened during platinum-based chemotherapy. The study will evaluate how well Nivolumab works in treating this type of cancer and monitor side effects.
Who can participate: You must be at least 18 years old with a confirmed diagnosis of squamous cell carcinoma that started in the nasopharynx. You must have previously received platinum-based chemotherapy that either did not work effectively or your cancer got worse during treatment. Your cancer must have either returned to the original location or lymph nodes, or spread to other parts of the body during or within 6 months after platinum chemotherapy. Your ECOG performance status must be 0-1, meaning you can care for yourself and are up and about more than 50% of waking hours. You must be willing to provide written informed consent, attend all follow-up visits, and undergo all planned study procedures.
Who cannot participate: Exclusions include being younger than 18, pregnancy or breastfeeding, previous immunotherapy treatment, active or untreated brain metastases, and active autoimmune disease requiring systemic treatment. You cannot participate if you have uncontrolled or severe heart disease, active hepatitis B or C infection, active tuberculosis, HIV infection or AIDS, or other active cancers requiring treatment (except certain skin cancers). Major surgery within 4 weeks before starting the study, treatment with other experimental drugs within 4 weeks, severe allergic reactions to similar medications in the past, or inability to give informed consent are also reasons for exclusion.
What the trial involves: The study aims to measure how the tumor responds to treatment at 12 weeks and 6 months using MRI scans. Nivolumab is given as an intravenous infusion containing 10 mg/mL of the active substance. After 12 weeks, doctors will check if the tumor has decreased in size by at least 30% or disappeared completely. At 6 months, another MRI scan will assess disease progression, and you will complete a quality of life questionnaire. Follow-up visits continue for up to 18 months, monitoring your overall survival and health status at 12 and 18 months.
Investigational drug: Nivolumab is a type of immunotherapy that helps your immune system fight cancer cells by blocking a protein called PD-1. This blocking action allows your immune system’s T-cells to better recognize and destroy cancer cells.
Study of Nivolumab, Cisplatin, and 5-Fluorouracil for Children and Adults with EBV-Positive Nasopharyngeal Cancer
This trial in Germany is investigating a combination of three medications given as induction therapy to help shrink tumors before other treatments like radiation. The study is particularly focused on children, adolescents, and young adults up to 25 years old.
Who can participate: You must have a new diagnosis of EBV-positive nasopharyngeal carcinoma confirmed by biopsy. If you are between 3 and 17 years old, the diagnosis must be confirmed according to current WHO classification. If you are 18 or older, you must have EBV-positive disease classified as WHO stage II or III. For those 25 years or younger, the cancer must be stage II or higher; if older than 25, it must be stage III or IV according to AJCC 8th edition. The cancer must be measurable by MRI scan following RECIST 1.1 criteria. Written informed consent is required from legal guardians for those under 18. Enough tumor tissue must be available for central review, including PD-L1 staining, requiring either 2 full blocks or at least 25 slides from a biopsy or surgical specimen.
Who cannot participate: You cannot participate if you do not have EBV-positive nasopharyngeal carcinoma or if you are older than 25 years. Patients with diseases or conditions that prevent undergoing MRI or PET-CT scans are excluded. You cannot join if you are unable to receive induction chemotherapy or if your radiotherapy dosage cannot be reduced from 59.4 Gy to 54 Gy.
What the trial involves: The main goal is to see if this combination of medications can increase the number of patients who have a complete response (no signs of cancer) as seen on imaging tests. This could potentially allow for a reduction in the amount of radiation therapy needed. All three medications are given intravenously. You will undergo initial assessments including MRI and PET-CT to measure disease extent, then receive the medication combination with regular follow-up appointments to monitor response and side effects. The study monitors complete remission rate, event-free survival, overall survival, and treatment safety and tolerability.
Investigational drugs: The study uses three medications: Nivolumab, an immune checkpoint inhibitor that helps your immune system recognize and attack cancer cells by blocking the PD-1 protein; Cisplatin, a chemotherapy drug that damages cancer cell DNA to stop them from growing and dividing; and 5-Fluorouracil, a chemotherapy medication that interferes with cancer cells’ ability to make DNA and RNA, which are essential for their growth and survival.
Study of Pembrolizumab and Olaparib for Adults with Recurrent or Metastatic, Platinum-Resistant Nasopharyngeal Cancer
This trial in Italy combines two different types of targeted therapy for patients whose cancer has returned or spread and is resistant to platinum-based treatment. The study tests whether combining an immunotherapy drug with a medication that interferes with cancer cell repair can improve treatment outcomes.
Who can participate: You must be at least 18 years old with adequate organ function confirmed by tests done within 10 days before starting treatment. You must have a confirmed diagnosis that is not treatable with surgery or radiation with curative intent. The disease must have progressed within 6 months after previous platinum-based chemotherapy. You must have measurable disease based on RECIST 1.1 criteria. Your ECOG performance status must be 0 to 1, meaning you can perform daily activities with little or no restriction. Male participants must agree to use contraception during treatment and for at least 6 months after the last dose and should not donate sperm during this time. Female participants must not be pregnant or breastfeeding and must agree to use contraception if they can become pregnant. You must have a life expectancy of at least 16 weeks.
Who cannot participate: Exclusions include having a different type of cancer than the one being studied, not having been previously treated with platinum-based chemotherapy, currently receiving another form of cancer treatment, or having serious health conditions that could interfere with the study. Pregnant or breastfeeding patients cannot join. Other exclusions include major surgery within the last 4 weeks, active infection requiring treatment, history of severe allergic reactions to the study medication, or inability to follow study procedures.
What the trial involves: After initial eligibility confirmation through medical history review, physical examination, and laboratory tests, you will receive pembrolizumab through an intravenous infusion followed by olaparib taken orally as film-coated tablets. Treatment continues according to the healthcare team’s schedule with regular monitoring visits including physical exams, imaging tests, and laboratory tests. The primary goal is to evaluate the objective response rate by the third radiological examination at approximately 27 weeks, measuring whether cancer lesions have disappeared completely or reduced significantly in size. The study also tracks progression-free survival, overall survival, adverse events, and changes in quality of life using a specific questionnaire for head and neck cancer patients. Some participants may receive a placebo for comparison purposes.
Investigational drugs: Pembrolizumab is an immunotherapy that works by blocking a protein called PD-1 on immune cells, helping the immune system recognize and attack cancer cells more effectively. Olaparib is a PARP inhibitor that prevents cancer cells from repairing themselves by blocking an enzyme involved in DNA repair, leading to cancer cell death.
Summary
The four ongoing clinical trials for nasopharyngeal cancer are distributed across four European countries, each focusing on different treatment approaches. A notable pattern is the strong emphasis on immunotherapy, with three of the four trials investigating immunotherapy medications: Nivolumab is tested in two trials (Poland and Germany), while Pembrolizumab is studied in Italy. These immunotherapy drugs work by helping the immune system recognize and fight cancer cells.
Three trials specifically target patients whose cancer has not responded to or has progressed after platinum-based chemotherapy, reflecting the critical need for alternative treatments in platinum-resistant cases. The German trial stands out as the only study including pediatric patients, accepting participants as young as 3 years old alongside adults up to 25 years, and combining immunotherapy with traditional chemotherapy drugs.
The Dutch trial takes a different approach by focusing on advanced imaging techniques rather than treatment, aiming to better characterize tumors and potentially identify patients who might benefit from targeted therapies in the future. The strong association with Epstein-Barr virus is evident in three of the four trials, highlighting the virus’s important role in this type of cancer.
All trials require participants to have adequate organ function and the ability to undergo regular monitoring through imaging tests and medical assessments. Most studies exclude patients with severe health conditions, active infections, or those who are pregnant or breastfeeding. The geographic distribution of these trials provides patients across different European countries with access to innovative treatment options.
