Thyroid cancer – Trials in Disease

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Clinical Trials for Thyroid Cancer

There are currently 11 ongoing clinical trials for thyroid cancer testing various treatments including targeted therapies, immunotherapies, and imaging techniques. These trials are being conducted across multiple European countries including Italy, France, Spain, Poland, Belgium, Netherlands, and Romania, offering opportunities for patients with different types and stages of thyroid cancer to access new treatment options.

Clinical trial locations

Evaluation of personalized Iodine-131 therapy using PET imaging in patients with metastatic thyroid cancer

This trial in Italy is exploring a personalized approach to treating metastatic differentiated thyroid cancer using radioactive iodine. The study uses advanced PET imaging with Iodine-124 to determine the optimal dose of Iodine-131 treatment for each individual patient, rather than using standard fixed doses.

Main inclusion criteria: Participants must be adults aged 18 to 75 with confirmed differentiated thyroid cancer that has spread to soft tissues and cannot be treated with surgery. They must have good physical function, a life expectancy greater than 6 months, and adequate blood and kidney function. Women of childbearing potential must use birth control during and for 6 months after treatment.

Main exclusion criteria: The trial excludes patients under 18 or over 75, pregnant or breastfeeding women, those with severe kidney or bone marrow problems, patients who have received chemotherapy or radiation in the past 4 weeks, and those with serious heart conditions or other active cancers.

Trial focus: The study aims to determine if personalizing radioactive iodine doses based on detailed PET imaging can improve treatment effectiveness compared to standard approaches. Patients may receive up to two treatments, and their response will be evaluated using imaging and blood tests at 6 months after the final treatment.

Investigational treatments: The trial uses Iodine-131 for treatment and Iodine-124 for PET imaging. Both are radioactive forms of iodine that target thyroid cancer cells, which naturally absorb iodine.

Study Comparing Two Treatment Strategies for Intermediate-Risk Thyroid Cancer Using Sodium Iodide (131I) in Patients with Post-Surgery Evaluation

This French trial is comparing two approaches for treating intermediate-risk differentiated thyroid cancer with radioiodine. One group receives routine radioiodine treatment, while the other has treatment decisions guided by post-surgery blood tests and imaging.

Main inclusion criteria: Patients must be 18 or older with intermediate-risk differentiated thyroid cancer, including papillary, follicular, or Hürthle cell types with specific characteristics. They must have undergone complete thyroid removal 6 to 14 weeks before joining, have started thyroid hormone replacement, and be able to perform daily activities with minimal assistance.

Main exclusion criteria: The study excludes patients who don’t have intermediate-risk differentiated thyroid cancer, those outside the specified age range, and vulnerable populations.

Trial focus: The study aims to determine if a strategy guided by post-operative tests provides similar or better outcomes compared to routine radioiodine treatment. Response to treatment will be assessed at 1, 3, and 5 years, along with quality of life measures.

Investigational treatments: Sodium iodide (131I) is administered as oral capsules in dosages ranging from 37 to 5550 MBq, depending on individual patient needs.

Study of Pembrolizumab for Patients with High-Risk Thyroid Cancer

This Italian study is investigating pembrolizumab, an immunotherapy drug, as a treatment before surgery in patients with high-risk thyroid cancer. The goal is to understand how the medication affects the immune system’s ability to fight cancer.

Main inclusion criteria: Participants must be at least 18 years old with confirmed differentiated thyroid cancer that is a candidate for surgery and has not been previously treated. They must have a risk greater than 20% for persistent or recurrent disease, measurable disease on scans, and good organ function. Women of childbearing potential must use birth control during treatment and for 4 months after.

Main exclusion criteria: The trial excludes patients with other types of cancer, those who received previous treatment for their thyroid cancer, patients with serious heart or blood pressure problems, active infections, autoimmune diseases, or those who are pregnant or breastfeeding.

Trial focus: The study aims to evaluate if pembrolizumab can shrink tumors before surgery and potentially improve outcomes for high-risk patients. Regular monitoring will assess tumor response and immune system changes.

Investigational treatments: Pembrolizumab is administered as an intravenous infusion. It is an immunotherapy medication that helps the immune system recognize and attack cancer cells by blocking the PD-1 protein.

Study on [18F]PSMA-11 PET Imaging for Patients with Advanced Thyroid and Head and Neck Cancer

This Belgian trial is studying a special imaging agent called [18F]PSMA-11 used in PET scans to better detect cancer in patients with advanced thyroid cancer and head and neck squamous cell carcinoma.

Main inclusion criteria: Participants must be at least 18 years old, willing to provide written consent, and have at least one measurable lesion that is 1.0 cm or larger on medical imaging.

Main exclusion criteria: The study excludes patients with cancer types other than those specified, those outside the specified age range, and vulnerable populations unable to give consent.

Trial focus: The study aims to observe how well the imaging agent is taken up by cancerous lesions, which can help in understanding the extent of disease and improving diagnosis.

Investigational treatments: [18F]PSMA-11 is administered as an intravenous injection. It is a radiopharmaceutical that binds to proteins on certain cancer cells, making them visible on PET scans.

Study on Sacituzumab Govitecan for Patients with Advanced Differentiated and Anaplastic Thyroid Cancer

This Spanish study is evaluating sacituzumab govitecan, an antibody-drug conjugate, for patients with advanced differentiated and anaplastic thyroid cancer. The trial includes two groups: one for patients with advanced differentiated cancer that doesn’t respond to radioiodine, and another for those with advanced anaplastic cancer.

Main inclusion criteria: Patients must be 18 or older with confirmed advanced thyroid cancer that cannot be surgically removed. Those with differentiated cancer must have tried at least one previous treatment but no more than three, while anaplastic cancer patients can be in first or second treatment line. Patients must have measurable disease, provide tumor tissue samples, and have adequate organ function.

Main exclusion criteria: The study excludes patients who haven’t been diagnosed with the specific types of advanced thyroid cancer being studied, those outside the age range, and vulnerable populations.

Trial focus: The main goal is to see if sacituzumab govitecan can help reduce tumor size in these challenging types of thyroid cancer. The study will also monitor treatment duration and overall survival.

Investigational treatments: Sacituzumab govitecan is administered intravenously. It targets the TROP-2 protein found on cancer cells and delivers a toxic substance directly to destroy them while minimizing damage to normal cells.

Study on Selpercatinib for Adults with Advanced or Metastatic Solid Tumors with RET Activation

This expanded access program in France, Poland, Italy, and Spain provides selpercatinib to patients with various cancers, including papillary and medullary thyroid cancer, that have specific genetic changes in the RET gene. This is not a traditional research trial but rather a program to provide access to treatment.

Main inclusion criteria: Patients must be 18 or older with locally advanced or metastatic tumors showing RET gene alterations. They must not be eligible for other ongoing selpercatinib trials and have progressed on or be intolerant to standard therapies. Adequate blood, kidney, and liver function are required, and patients must use effective birth control methods.

Main exclusion criteria: The program excludes patients younger than 18, those without RET alterations, pregnant or breastfeeding women, patients with untreated brain metastases, and those with serious heart problems or active infections.

Program focus: The program aims to provide access to selpercatinib for eligible patients who have no other treatment options available.

Investigational treatments: Selpercatinib is taken orally and works by inhibiting the RET protein, which is involved in cancer cell growth and division. By blocking this protein, it can help slow or stop cancer growth.

Study on the Effect of Metformin on Fertility in Women with Thyroid Cancer Treated with Radioactive Iodine

This Polish study is exploring whether metformin, a medication commonly used for diabetes, can improve fertility in women treated with radioactive iodine for papillary thyroid cancer. Participants will receive either metformin or placebo, and fertility indicators will be measured.

Main inclusion criteria: Participants must be female, between 18 and 45 years old, diagnosed with papillary thyroid cancer, and not yet treated with radioactive iodine (131I). They must be willing to follow study procedures.

Main exclusion criteria: The study excludes male patients, those not diagnosed with papillary thyroid cancer, patients who have already undergone 131I treatment, and those outside the specified age range.

Trial focus: The study evaluates how metformin affects hormone levels and the number of ovarian follicles measured by ultrasound. It also assesses quality of life using a thyroid cancer-specific questionnaire.

Investigational treatments: Metformin hydrochloride is administered orally as tablets. While typically used for diabetes, this study explores its potential benefits on fertility in women who have undergone thyroid cancer treatment.

Study on [18F]Tetrafluoroborate PET/CT for Detecting Thyroid Cancer in Patients with Differentiated Thyroid Cancer

This Dutch study is investigating [18F]Tetrafluoroborate PET/CT imaging to detect cancer spread to lymph nodes before surgery and to predict response to radioiodine therapy in patients with differentiated thyroid cancer.

Main inclusion criteria: Patients must be 18 or older with differentiated thyroid cancer and an ECOG status of 0-2. The study includes two groups: newly diagnosed patients with confirmed lymph node spread scheduled for surgery, and patients scheduled for radioiodine therapy.

Main exclusion criteria: The study excludes patients without differentiated thyroid cancer, those outside the age range, and vulnerable populations.

Trial focus: The study aims to determine the best timing for PET/CT imaging and evaluate how well this imaging method can detect lymph node involvement and predict treatment response.

Investigational treatments: [18F]Tetrafluoroborate is administered intravenously. It is a radiopharmaceutical that highlights cancer cells in PET/CT scans, helping doctors visualize cancer spread.

Study of Cabozantinib in Adults with Progressive Thyroid Cancer Who Did Not Respond to Previous Treatment with Radioactive Iodine and VEGFR Therapy

This trial in Poland, Romania, and Spain is testing cabozantinib against placebo in patients with radioiodine-refractory differentiated thyroid cancer that has continued to grow after previous treatments targeting blood vessel growth.

Main inclusion criteria: Patients must be 16 or older with confirmed thyroid cancer, receiving thyroid hormone therapy with specific blood test requirements. They must have measurable disease, previously received radioiodine treatment or been deemed unsuitable for it, and tried at least one targeted therapy. Adequate organ function and good physical functioning status are required.

Main exclusion criteria: The trial excludes patients under 18, those with severe allergic reactions to cabozantinib, pregnant or breastfeeding women, patients with untreated brain metastases, significant heart problems, uncontrolled high blood pressure, severe liver or kidney problems, and active infections.

Trial focus: The study aims to determine if cabozantinib can slow or stop cancer growth in patients whose disease has worsened after previous therapy. The treatment may continue for up to 51 months with regular monitoring.

Investigational treatments: Cabozantinib is taken orally as film-coated tablets. It works by blocking specific proteins involved in cancer cell growth and blood vessel formation.

Study of JK08, Pembrolizumab, and Lenvatinib for Patients with Advanced or Metastatic Cancer

This trial in Belgium and Spain is studying JK08, an experimental immunotherapy, both alone and in combination with pembrolizumab and lenvatinib for patients with various advanced cancers, including thyroid cancer that cannot be surgically removed.

Main inclusion criteria: Patients must be at least 18 years old and willing to have tumor biopsies before and during treatment. Women of childbearing potential must use birth control, and men must use barrier contraception. Patients must have tried standard treatments without success or be unable to have them for medical reasons. They need measurable disease, a performance status of 0 or 1, and a life expectancy of at least 12 weeks.

Main exclusion criteria: The study has specific exclusion criteria that would be discussed during the eligibility assessment process.

Trial focus: The study aims to understand the safety and tolerability of JK08 and determine the best dose for patients. It begins with dose-finding, then expands to include more patients for further evaluation.

Investigational treatments: JK08 is administered as a subcutaneous injection under the skin. Some patients may also receive pembrolizumab by infusion or lenvatinib as oral capsules, depending on their cancer type.

Study on Cabozantinib for Patients with Advanced Radioactive-Iodine Refractory Differentiated Thyroid Cancer

This Spanish study is exploring cabozantinib in patients with advanced differentiated thyroid cancer that does not respond to radioactive iodine treatment. The trial will also investigate blood markers that might predict how patients respond to treatment.

Main inclusion criteria: Patients must be 18 or older with confirmed radioiodine-refractory differentiated thyroid cancer, measurable disease, and adequate organ function. They must have been treated with or found ineligible for radioiodine treatment and shown disease progression with one or two specific targeted therapies. Women of childbearing potential and men must agree to use effective birth control methods.

Main exclusion criteria: The study excludes patients without the specific diagnosis of advanced radioiodine-refractory differentiated thyroid cancer, those outside the age range, and vulnerable populations.

Trial focus: The study aims to understand how well cabozantinib controls the disease and whether specific blood markers can predict treatment effectiveness. Blood samples will be collected at baseline, after 24 weeks, and at the end of treatment.

Investigational treatments: Cabozantinib is taken orally as film-coated tablets in strengths of 20 mg, 40 mg, and 60 mg. It is a tyrosine kinase inhibitor that blocks proteins involved in tumor growth and blood vessel development.

Summary

The 11 ongoing clinical trials for thyroid cancer represent a diverse range of therapeutic approaches and research questions. Several trials focus on personalized medicine, particularly in the use of radioactive iodine therapy, with studies in Italy and France exploring whether treatment guided by advanced imaging or post-surgical assessments can improve outcomes compared to standard approaches.

Targeted therapies are prominently featured, with multiple trials investigating cabozantinib for patients whose cancer no longer responds to radioiodine treatment. These studies are being conducted in Spain, Poland, and Romania, reflecting the significant unmet need for effective treatments in radioiodine-refractory disease.

Immunotherapy approaches are also being explored, with trials testing pembrolizumab in Italy and combination immunotherapy strategies in Belgium and Spain. The Italian study uniquely focuses on using immunotherapy before surgery in high-risk patients.

Advanced imaging techniques are the subject of several trials, with studies in Belgium, Netherlands, and others investigating new imaging agents that could improve cancer detection and treatment planning. These imaging studies may help doctors better identify cancer spread and predict treatment response.

Notably, one Polish trial addresses an important quality-of-life issue by studying whether metformin can help preserve fertility in women treated with radioiodine for thyroid cancer, demonstrating attention to long-term effects of cancer treatment.

Spain appears to be a particularly active location for thyroid cancer research, hosting five different trials covering various aspects of treatment and imaging. The geographic distribution of these trials across multiple European countries provides opportunities for patients in different regions to access investigational treatments.

Ongoing Clinical Trials on Thyroid cancer

  • Study on [18F]Tetrafluoroborate PET/CT for Detecting Thyroid Cancer in Patients with Differentiated Thyroid Cancer

    Recruiting

    1 1
    Investigated diseases:
    The Netherlands
  • Study on the Effect of Metformin on Fertility in Women with Thyroid Cancer Treated with Radioactive Iodine

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland
  • Study Comparing Two Treatment Strategies for Intermediate-Risk Thyroid Cancer Using Sodium Iodide (131I) in Patients with Post-Surgery Evaluation

    Recruiting

    1 1 1 1
    Investigated drugs:
    France
  • Study on [18F]PSMA-11 PET Imaging for Patients with Advanced Thyroid and Head and Neck Cancer

    Recruiting

    1 1
    Investigated drugs:
    Belgium
  • Study on Cabozantinib for Patients with Advanced Radioactive-Iodine Refractory Differentiated Thyroid Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain
  • Study of JK08, Pembrolizumab, and Lenvatinib for Patients with Advanced or Metastatic Cancer

    Not recruiting

    1 1 1
    Belgium Spain
  • Study of Cabozantinib in Adults with Progressive Thyroid Cancer Who Did Not Respond to Previous Treatment with Radioactive Iodine and VEGFR Therapy

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland Romania Spain