Ongoing Clinical Trials for Squamous Cell Carcinoma of the Hypopharynx
Four clinical trials are currently recruiting patients with squamous cell carcinoma of the hypopharynx. These studies are testing different treatment approaches, including immunotherapy with pembrolizumab, targeted therapy with afatinib and lenvatinib, and various combinations of chemotherapy and radiotherapy. Trials are taking place in Germany, Spain, and France, offering opportunities for patients at different disease stages.
Clinical trial locations
- France
- Germany
- Study on Pembrolizumab and Drug Combination for Patients with Recurrent Head and Neck Cancer
- Study of Pembrolizumab with Lenvatinib after Chemoradiation Treatment in Patients with Locally Advanced Head and Neck Cancer who are PD-L1 Positive
- Study on the Safety and Effectiveness of Afatinib for Fanconi Anemia Patients with Advanced Squamous Cell Carcinoma in the Oral Cavity, Oropharynx, Hypopharynx, or Larynx
- Spain
Study on Pembrolizumab and Drug Combination for Patients with Recurrent Head and Neck Cancer
This study focuses on patients whose cancer has returned in the head and neck area after previous treatment. The trial compares two different treatment approaches to see which helps patients live longer.
Main inclusion criteria: Participants must be at least 18 years old with cancer that has come back in the same area after earlier treatment. The tumor must test positive for a protein called PD-L1 with a score of at least 1. Patients should have received radiation therapy or combined radiation and chemotherapy at least 6 months before joining the study. The cancer cannot have spread to distant parts of the body, and it must not be possible to remove it surgically without causing serious problems with daily functions like speaking or swallowing. Patients need to be able to carry out most daily activities with minimal or no help.
Main exclusion criteria: People with other types of cancer, those who are pregnant or breastfeeding, and patients with severe medical conditions that could interfere with the study cannot participate. Those with known allergies to the study medications or who recently participated in another clinical trial may also be excluded.
Focus and goal: The study examines whether giving sequential re-radiochemotherapy followed by pembrolizumab works better than pembrolizumab with or without chemotherapy. The goal is to improve overall survival and help control the cancer better than current standard treatments. Researchers will also assess quality of life and monitor any side effects.
Investigational drugs: Pembrolizumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is given through an intravenous infusion. The study also uses chemotherapy drugs including fluorouracil, carboplatin, and cisplatin, combined with radiation therapy in one of the treatment groups.
Study on the Safety and Effectiveness of Afatinib for Fanconi Anemia Patients with Advanced Squamous Cell Carcinoma in the Oral Cavity, Oropharynx, Hypopharynx, or Larynx
This trial is designed for a specific group of patients who have both Fanconi anemia and cancer affecting areas such as the mouth, throat, and voice box. The study tests whether afatinib can safely and effectively treat these cancers when they cannot be surgically removed or have spread.
Main inclusion criteria: Participants must be 18 years or older with a confirmed diagnosis of Fanconi anemia and squamous cell carcinoma that cannot be removed by surgery or has spread to nearby areas. The cancer should not be suitable for other standard treatments like radiotherapy, chemotherapy, or immunotherapy that could potentially cure it. Patients must have at least one measurable tumor and adequate organ function, including sufficient levels of blood cells, normal kidney and liver function, and acceptable blood clotting results. Previous cancer treatments are allowed if they ended at least 6 weeks before starting this study.
Main exclusion criteria: Patients without Fanconi anemia or without the specific type of cancer being studied cannot participate. Those outside the specified age range or who do not meet the organ function requirements are also excluded.
Focus and goal: The study aims to understand how well afatinib works in controlling cancer and improving quality of life for patients with Fanconi anemia. Researchers will compare different doses of the medication to determine the most effective approach while monitoring for side effects.
Investigational drug: Afatinib is taken as oral tablets in strengths of 20 mg, 30 mg, or 40 mg. It works by blocking proteins that help cancer cells grow and spread, specifically targeting the epidermal growth factor receptor and related pathways.
Study of Pembrolizumab with Lenvatinib after Chemoradiation Treatment in Patients with Locally Advanced Head and Neck Cancer who are PD-L1 Positive
This study examines whether adding lenvatinib to pembrolizumab treatment after initial chemotherapy and radiation can prevent cancer from returning in patients with locally advanced disease.
Main inclusion criteria: Patients must be 18 years or older with locally advanced cancer confirmed through tissue examination. The tumor must test positive for PD-L1 with a score of 1 or higher. Participants must have completed combined radiation therapy with at least 68 Gray and received at least 200 mg/m² of cisplatin chemotherapy. The cancer must not have grown or spread during the initial treatment. Patients should be fully active or able to carry out light work, even if unable to perform physically strenuous activities.
Main exclusion criteria: People with other cancers in the past 5 years, active brain metastases, autoimmune diseases requiring treatment, organ transplants, hepatitis B or C, HIV, uncontrolled high blood pressure, recent heart attacks, active bleeding problems, pregnancy, breastfeeding, or known allergies to study medications cannot participate. Those who participated in other clinical trials within the past 30 days are also excluded.
Focus and goal: The trial determines whether using pembrolizumab together with lenvatinib after completing initial treatment works better than pembrolizumab alone in preventing cancer recurrence. The treatment may last up to 2 years, during which patients receive regular check-ups and imaging tests to monitor their response.
Investigational drugs: Pembrolizumab is given through intravenous infusion and helps the immune system fight cancer by blocking the PD-L1 protein. Lenvatinib is taken as oral capsules and works by blocking proteins that cancer cells need to grow and create new blood vessels, helping to slow or stop cancer growth.
Study on Preserving the Voice Box in Patients with Advanced Laryngeal or Hypopharyngeal Cancer Using Cisplatin, Fluorouracil, and Docetaxel Therapy
This French study focuses on preserving the voice box and throat function in patients with locally advanced cancer. It compares different sequences of chemotherapy and radiotherapy to find the best approach for maintaining the ability to speak and swallow normally.
Main inclusion criteria: Patients must have locally advanced squamous cell carcinoma in the larynx or hypopharynx confirmed by tissue examination. The cancer should be at stage T2 or T3 and require surgery that would remove the voice box, but without needing to remove a circular part of the hypopharynx. The cancer must not have spread to distant parts of the body, confirmed by chest CT scan, abdominal imaging, and bone scan if needed. Patients should not have received previous treatment for this cancer and must be fully active or have only minor symptoms without needing help with daily activities. The tumor must be measurable according to standard criteria.
Main exclusion criteria: Patients with other types of cancer, those who have had previous treatments that might interfere with the study, people with severe medical conditions, pregnant or breastfeeding women, and those with allergies to study medications cannot participate. People unable to follow study procedures, participating in another trial, or with a history of substance abuse or mental health conditions that might interfere are also excluded.
Focus and goal: The study aims to determine which treatment method is better at helping patients survive while preserving their voice box function and avoiding major surgery. One approach uses a combination of chemotherapy drugs followed by radiotherapy, while the other gives cisplatin at the same time as radiotherapy. Researchers will monitor survival rates, functional preservation, and quality of life.
Investigational drugs: The study uses three chemotherapy drugs given through intravenous infusion: cisplatin, which damages cancer cell DNA; 5-fluorouracil, which interferes with the cancer cells’ ability to make DNA and RNA; and docetaxel, which disrupts structures that help cancer cells divide. These drugs are combined with radiotherapy, which uses high-energy rays to destroy cancer cells.
Summary
These four clinical trials offer different treatment options for patients with squamous cell carcinoma of the hypopharynx at various stages of disease. Germany hosts three of the four trials, making it a key location for research in this area. The studies test several therapeutic approaches: immunotherapy with pembrolizumab alone or combined with other drugs, targeted therapy with afatinib, and traditional chemotherapy combinations with radiotherapy.
A notable focus across multiple trials is the use of pembrolizumab, an immunotherapy drug that requires tumors to test positive for PD-L1. Two studies specifically target patients whose cancer has recurred or is locally advanced after initial treatment, while one French study emphasizes preserving the voice box and throat function. The Spanish-German trial uniquely focuses on patients with the rare genetic condition Fanconi anemia.
Patients interested in participating should discuss eligibility with their healthcare providers, as each trial has specific requirements regarding disease stage, previous treatments, and general health status.
