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Squamous cell carcinoma of head and neck – Trials in Disease

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Ongoing Clinical Trials for Squamous Cell Carcinoma of Head and Neck

Squamous cell carcinoma of head and neck is a type of cancer that begins in the flat cells lining the moist surfaces inside the head and neck region, including the mouth, throat, nose, and voice box. Currently, there are 53 clinical trials investigating various treatment approaches for this disease, ranging from immunotherapy combinations to targeted therapies and novel treatment regimens. These trials are being conducted across multiple countries in Europe and involve both newly diagnosed and recurrent/metastatic cases.

Clinical trial locations

Study of Amivantamab, Pembrolizumab, and Paclitaxel for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This trial is investigating treatment options for patients with recurrent or metastatic head and neck cancer. Participants must have a diagnosis confirmed through tissue analysis showing PD-L1 positivity. The study focuses on patients whose cancer has either returned after initial treatment or has spread to other parts of the body and cannot be treated with surgery or radiation aimed at cure.

The main inclusion criteria require patients to be adults with adequate organ and bone marrow function. Specific blood test values must be within acceptable ranges, including liver enzymes, bilirubin, creatinine levels, and blood cell counts. Patients must also have recovered from previous treatments to a mild level, except for certain conditions like hair loss or stable nerve damage.

The trial involves several treatment approaches. Some participants will receive amivantamab alone, while others will receive it combined with pembrolizumab, an immunotherapy medication that helps the immune system fight cancer. Another group will receive amivantamab with paclitaxel, a chemotherapy drug that stops cancer cells from growing. The medications are administered through intravenous infusion.

Key exclusion criteria include patients who have received prior treatment with anti-PD-1 or anti-PD-L1 antibodies, those with uncontrolled brain metastases, or those with significant heart disease or active infections. The study also excludes pregnant or breastfeeding women and patients who cannot follow study procedures.

Study of Carboplatin, Paclitaxel, and Cetuximab for Patients with Recurrent or Metastatic Head and Neck Cancer After Pembrolizumab Treatment Failure

This study focuses on patients whose head and neck cancer has progressed after initial treatment with pembrolizumab. Patients must be at least 18 years old and have adequate health status as measured by WHO performance status scores. The cancer must be in specific locations including the mouth, throat, voice box, or lower throat, and be classified as stage III, IVa, or IVb.

The treatment combines three medications: carboplatin and paclitaxel (both chemotherapy drugs) along with cetuximab, a targeted therapy that blocks specific proteins on cancer cells. These medications are administered through intravenous infusion. The study aims to evaluate whether this combination can effectively manage cancer that has not responded to previous immunotherapy treatment.

Patients must have tumor progression documented through imaging tests and must have adequate kidney, liver, and bone marrow function as shown through blood tests. The study monitors how well the cancer responds to treatment through regular assessments including imaging tests and physical examinations. Side effects are carefully tracked according to established criteria.

Exclusion criteria include patients without confirmed diagnosis of the specific cancer type being studied, those outside the specified age range, or those who cannot follow study procedures. The trial also excludes certain vulnerable populations who may need special protection.

Study of Cetuximab and Avelumab for Patients with Recurrent or Metastatic Head and Neck Cancer with PD-L1 Score 1 or Higher

This trial evaluates a combination of cetuximab and avelumab for patients with head and neck cancer that has returned or spread. The cancer must test positive for PD-L1 with a score between 1 and 19. Participants must not have received previous systemic therapy for their recurrent or metastatic disease, though prior treatment for earlier-stage disease is allowed if completed more than 6 months before enrollment.

Patients must have measurable disease and good general health status with an ECOG performance score of 0 or 1. The treatment involves two main phases: initial treatment with cetuximab combined with platinum-based chemotherapy, followed by maintenance therapy with both avelumab and cetuximab. All medications are given through intravenous infusion.

Key inclusion criteria include adequate liver, kidney, and blood cell function. Patients must provide a tissue sample for laboratory testing and have their HPV status documented if the cancer is in the throat area. The study closely monitors participants for treatment response and side effects throughout the trial period, which can last up to 12 months.

Patients are excluded if they have severe heart problems, uncontrolled infections, are pregnant or breastfeeding, have autoimmune diseases requiring treatment, or have had organ transplants. Those with active infections requiring treatment or uncontrolled high blood pressure are also excluded from participation.

Study of Cetuximab and Paclitaxel for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Pembrolizumab Treatment

This study examines treatment options for patients whose cancer has progressed after receiving pembrolizumab combined with platinum-based chemotherapy. Participants are randomly assigned to receive either weekly cetuximab combined with paclitaxel, or cetuximab alone. Both medications are administered through intravenous infusion.

Patients must be at least 18 years old with confirmed diagnosis of cancer in the throat, mouth, voice box, or lower throat. The cancer must have progressed after specific previous treatments as shown by imaging studies. Adequate organ function is required, including proper liver enzyme levels, kidney function, and blood cell counts. Patients must have an ECOG performance status of 0 or 1.

The trial requires patients to provide tumor tissue samples and have documented HPV status for throat cancers. Both men and women who can have children must use effective birth control methods during the study and for 180 days after the last treatment dose. The study monitors tumor response through regular imaging tests and physical examinations.

Exclusion criteria include patients without the specific type of cancer being studied, those not previously treated with pembrolizumab and platinum-based therapy, and those outside the specified age range. Patients who cannot follow study procedures or are part of vulnerable populations requiring special care are also excluded.

Study of Domvanalimab and Zimberelimab Combined with Chemotherapy for Previously Untreated Recurrent or Metastatic Head and Neck Cancer

This trial tests new combination treatments for patients who have not yet received systemic treatment for their recurrent or metastatic head and neck cancer. The study compares domvanalimab and zimberelimab with chemotherapy against zimberelimab with chemotherapy alone. All medications are administered through intravenous infusion.

Patients must be at least 18 years old with confirmed cancer that cannot be cured with local treatment. The cancer must be in specific locations including the throat, mouth, voice box, or lower throat. Participants must have measurable disease and adequate organ function including proper kidney, liver, and bone marrow function as shown through blood tests.

A key requirement is that tumor tissue samples show expression of PD-L1 protein at certain levels. For throat cancers, HPV status must be confirmed through testing. The study follows participants for up to 36 months to assess treatment effectiveness and safety. Regular monitoring includes imaging scans and blood tests to check organ function and detect side effects.

Exclusion criteria include prior treatment with anti-PD-1 or anti-PD-L1 therapy, active or untreated brain metastases, autoimmune diseases requiring treatment, and uncontrolled heart disease. Pregnant or breastfeeding women, those with active infections, and patients with other cancers within the past two years are also excluded.

Study of Dostarlimab After Chemoradiation for Adults with Advanced Unresected Head and Neck Cancer

This trial investigates dostarlimab as a follow-up treatment after patients complete combined chemotherapy and radiation therapy. The study compares dostarlimab to placebo in patients whose cancer is locally advanced and cannot be removed by surgery. Participants must have completed chemoradiation treatment and must test positive for PD-L1 protein in their tumor tissue.

Patients must be at least 18 years old with newly diagnosed cancer that cannot be surgically removed. The cancer must be in specific areas including the mouth, throat, or voice box. Required chemotherapy includes cisplatin, and radiation therapy must meet minimum dosage requirements. Adequate organ and bone marrow function is necessary, with specific requirements for blood cell counts and kidney function.

The treatment involves receiving dostarlimab as an intravenous infusion at a dose of 500 mg. Participants are randomly assigned to receive either the active medication or placebo. Regular monitoring includes physical examinations, blood tests, and imaging studies to evaluate treatment response and detect any side effects.

Key exclusion criteria include patients who have had surgery to remove their cancer, those without PD-L1 expression in tumor tissue, and those not meeting age requirements. Patients with other types of cancer, those who have received prior radiation or chemotherapy for their current cancer, or those with serious heart problems are excluded. Pregnant or breastfeeding women and patients with uncontrolled infections also cannot participate.

Study of INBRX-106 and Pembrolizumab for First-Line Treatment in Patients with Recurrent or Metastatic Head and Neck Cancer

This study evaluates a combination of INBRX-106 and pembrolizumab for patients who have not received previous treatment for their advanced cancer. The trial compares this combination against pembrolizumab alone. Participants must have cancer that has returned or spread and tests positive for PD-L1 protein with a score of 20 or higher.

Patients must be at least 18 years old with adequate organ function including proper blood cell counts, kidney function, and liver function. The cancer must be in the mouth, throat, voice box, or lower throat, and must be measurable through imaging scans. Patients must provide tumor tissue samples or undergo a biopsy if needed.

Both medications are administered through intravenous infusion once weekly. The study monitors tumor response using standardized measurement criteria and tracks any side effects experienced by participants. Quality of life assessments are conducted using specific questionnaires throughout the treatment period.

Exclusion criteria include prior treatment with PD-1 or PD-L1 inhibitors, active brain metastases, autoimmune diseases requiring treatment within the past two years, and active infections requiring therapy. Patients with severe heart disease, high blood pressure, or lung inflammation are excluded. Those with known HIV, hepatitis B, or hepatitis C infections, or with other cancers within the past three years, cannot participate.

Study of Niraparib and Dostarlimab with Radiotherapy for Patients with Locally-Advanced Head and Neck Cancer

This trial investigates niraparib and dostarlimab in combination with radiotherapy for patients with locally advanced cancer. Participants are divided into two groups based on their ability to receive cisplatin chemotherapy. One group receives niraparib, dostarlimab, radiotherapy, and cisplatin, while the other receives niraparib, dostarlimab, and radiotherapy without cisplatin.

Patients must be at least 18 years old with newly diagnosed cancer that has not spread to distant sites. The cancer must be in the mouth, throat, or voice box. For throat cancers, HPV status must be confirmed through testing. Adequate organ function is required, including proper blood cell counts, liver function, and kidney function with creatinine clearance of at least 60 mL/min for those receiving cisplatin.

Niraparib is taken orally as tablets with a dosage of 100 mg per tablet, while dostarlimab is given through intravenous infusion at 500 mg. The treatment period can last up to 12 months with regular monitoring including blood tests and imaging studies. The study aims to evaluate disease-free survival at one year as the primary outcome.

Exclusion criteria include patients with cancer that cannot be surgically removed or has spread to distant sites, those with severe heart, liver, or kidney problems, and those with uncontrolled infections. Pregnant or breastfeeding women, patients with autoimmune diseases, and those who have received organ transplants are excluded. Patients with allergies to the study medications or those participating in other trials are also not eligible.

Study of petosemtamab compared to standard therapy in previously treated patients with metastatic or recurrent head and neck cancer

This study compares petosemtamab to standard treatment options for patients whose cancer has continued to grow despite previous treatment with platinum-based therapy and immunotherapy. Participants are randomly assigned to receive either petosemtamab or one of several standard treatments including methotrexate, docetaxel, or cetuximab. All medications are given through intravenous infusion.

Patients must be at least 18 years old with confirmed cancer in the throat, mouth, voice box, or lower throat that has spread or returned locally after treatment. The cancer must show progression after anti-PD-1 therapy and platinum-based treatment. Adequate organ function is required, including proper blood cell counts, liver function, and kidney function.

The trial monitors how long patients live and how well their tumors respond to treatment. Regular imaging scans using CT or MRI are performed to measure tumor response. Blood tests are conducted to monitor organ function and detect any side effects. The study continues tracking patients until March 2028.

Exclusion criteria include history of severe allergic reactions, active or untreated brain metastases, significant heart conditions, uncontrolled infections, other cancer diagnoses within the past three years, pregnancy or breastfeeding, major surgery within four weeks, and participation in another trial within four weeks. Patients with autoimmune diseases, organ transplants, or those taking medications that could interact with study drugs are also excluded.

Study of petosemtamab with pembrolizumab compared to pembrolizumab alone in patients with head and neck cancer who have not received previous treatment for advanced disease

This trial evaluates whether combining petosemtamab with pembrolizumab works better than pembrolizumab alone for patients who have not received previous treatment for their advanced cancer. The tumors must show high levels of FGFR2b protein and must be PD-L1 positive. Both medications are administered through intravenous infusion.

Patients must be at least 18 years old with cancer in the throat, mouth, voice box, or lower throat that cannot be cured with local treatments. The cancer must be either newly diagnosed or recurring after previous treatment, with disease progression occurring at least six months after platinum-based therapy. Measurable disease must be present and documented through imaging scans.

Adequate organ function is required, including proper blood cell counts with neutrophils at least 1.5 x 10^9/L, platelets at least 100 x 10^9/L, and hemoglobin at least 9 g/dL. Liver function tests must show normal or near-normal values, and kidney function must be adequate. Patients must have an ECOG performance status of 0 or 1 and provide tumor tissue samples for testing.

Key exclusion criteria include prior treatment with anti-PD-1 or anti-EGFR therapies, active brain or spinal cord metastases, recent treatment with experimental medications, known severe allergic reactions to biological treatments, active infections requiring treatment, major surgery within 28 days, and significant heart problems. Pregnant or breastfeeding women and those with autoimmune diseases or other active cancers are excluded.

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

This trial investigates a special imaging agent called [18F]PSMA-11 used in PET scans to help doctors see cancer more clearly. The study aims to determine how well this imaging agent works in detecting cancer in patients with advanced forms of head and neck cancer and thyroid cancer. The agent is administered through intravenous injection.

Patients must be at least 18 years old with at least one measurable area of abnormal tissue that is 1.0 cm or larger as seen on medical imaging. The study involves receiving an injection of the imaging agent followed by PET scans to capture images of the cancerous areas. The goal is to observe how much of the imaging agent is taken up by the cancer, which helps understand the extent of the disease.

Throughout the study, participants receive regular check-ups to monitor their health and assess the uptake of the medication in tumors and organs. The imaging is performed at specific time intervals to determine the optimal timing for scanning. The study measures standardized uptake values to evaluate the distribution and effectiveness of the imaging agent.

Patients with other types of cancer besides the specified types, those not within the required age range, or those unable to give informed consent are excluded from the study. The trial aims to provide valuable information about whether this imaging technique can improve the diagnosis and treatment planning for these types of cancer.

Summary

The clinical trial landscape for squamous cell carcinoma of head and neck reveals a diverse array of treatment approaches being investigated across Europe. With 53 ongoing trials, the research spans multiple countries including France, Germany, Spain, Poland, Italy, Belgium, and the Netherlands, among others.

A notable trend is the focus on immunotherapy combinations, with pembrolizumab appearing in numerous trials either alone or combined with other agents. Several studies explore novel immunotherapy approaches, including checkpoint inhibitors like nivolumab, durvalumab, and atezolizumab. Many trials target PD-L1 positive tumors, reflecting the importance of biomarker-driven treatment selection.

Targeted therapies are also prominent, with trials investigating agents like cetuximab, amivantamab, and various tyrosine kinase inhibitors. Several studies focus on patients whose cancer has progressed after previous treatments, addressing an important unmet medical need for effective second-line and later-line therapies.

The trials encompass different disease stages, from locally advanced disease requiring neoadjuvant or adjuvant approaches to recurrent or metastatic disease. Some studies investigate radiation therapy modifications or combinations with systemic treatments. Notable is the attention to patient populations with specific characteristics, such as those unable to receive high-dose cisplatin or older patients requiring modified treatment approaches.

Several trials explore innovative approaches including peptide-based immunotherapies, cell therapies like tumor-infiltrating lymphocytes, and novel imaging techniques. The geographic distribution shows particular concentration of trials in Western European countries, though Eastern European participation is also evident. This extensive research activity reflects ongoing efforts to improve outcomes for patients with this challenging disease through multiple therapeutic strategies.

Ongoing Clinical Trials on Squamous cell carcinoma of head and neck

  • Study of Pembrolizumab and Cisplatin for Patients with Stage III-IVA Resectable Head and Neck Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium France Germany Hungary Ireland +3

  • Study on Radiotherapy with Xevinapant or Placebo for Older Patients with Advanced Head and Neck Cancer

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Ireland Italy The Netherlands +3

  • Study of IO102-IO103 and Pembrolizumab for Patients with Resectable Melanoma and Head and Neck Squamous Cell Carcinoma

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Germany Spain

  • Study of Retifanlimab, INCAGN02385, and INCAGN02390 for First-Line Treatment in Patients with PD-L1 Positive Recurrent/Metastatic Head and Neck Cancer

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Greece Italy Portugal Spain

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