Ongoing Clinical Trials for Squamous Cell Carcinoma of the Oral Cavity
Currently, there are 6 ongoing clinical trials investigating new treatments for squamous cell carcinoma of the oral cavity. These studies are testing various combinations of immunotherapy, chemotherapy, and targeted therapies across multiple countries in Europe, offering patients access to innovative treatment approaches that may improve outcomes and survival rates.
Clinical trial locations
- Belgium
- Germany
- Study of Pembrolizumab with Lenvatinib after Chemoradiation Treatment in Patients with Locally Advanced Head and Neck Cancer who are PD-L1 Positive
- Study on Pembrolizumab and Drug Combination for Patients with Recurrent Head and Neck Cancer
- 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
- Italy
- Netherlands
- Spain
Study on Pembrolizumab and Drug Combination for Patients with Recurrent Head and Neck Cancer
This trial is testing a treatment approach for patients whose cancer has returned in the head and neck area after initial treatment. The study compares two treatment options: one involves sequential re-radiochemotherapy followed by pembrolizumab, while the other uses pembrolizumab with or without chemotherapy.
Main inclusion criteria: Participants must be at least 18 years old with locoregionally recurrent head and neck cancer that cannot be surgically removed or where surgery would cause significant functional problems. The tumor must have a PD-L1 combined positive score of 1 or more, and patients must have previously received radiation therapy to the neck with at least a 6-month interval since the last treatment. Good organ and bone marrow function is required, including hemoglobin levels of at least 9.0 g/dL, white blood cell counts of at least 3,000 per mm3, and platelet counts greater than 100,000 per mm3.
Main exclusion criteria: Patients with other types of cancer besides locoregionally recurrent head and neck cancer are excluded. Those who are pregnant, breastfeeding, or have severe uncontrolled medical conditions cannot participate. Patients with known allergies to the study medications or who are unable to follow study procedures are also excluded.
Main focus: The trial aims to determine whether the combination of re-radiochemotherapy followed by pembrolizumab can improve overall survival compared to standard therapy. The study will monitor how well the treatment works in controlling the cancer and improving quality of life.
Investigational drugs: Pembrolizumab is an immunotherapy medication that helps the immune system fight cancer cells by blocking a pathway cancer cells use to hide. Re-radiochemotherapy combines radiation therapy with chemotherapy drugs such as fluorouracil, carboplatin, or cisplatin to target and kill cancer cells.
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 study focuses on patients with Fanconi anemia, a rare genetic disorder, who have developed advanced cancer in the mouth, throat, or voice box. The trial tests the medication afatinib to see how safe and effective it is in treating these cancers when they cannot be surgically removed or have spread.
Main inclusion criteria: Participants must be at least 18 years old with a confirmed diagnosis of Fanconi anemia and unresectable or locoregionally advanced cancer. The tumor must be confirmed through tissue examination and not be a candidate for surgical removal. At least one measurable lesion must be present on CT or MRI scans. Good performance status and adequate organ function are required, including neutrophils greater than 1000 cells per microliter, platelets greater than 50,000 cells per microliter, and hemoglobin greater than 8 grams per deciliter.
Main exclusion criteria: Patients without Fanconi anemia or unresectable cancer cannot participate. Those outside the specified age range or not meeting health criteria are excluded. Patients unable to give informed consent or with known allergies to the medication are not eligible.
Main focus: The study aims to understand how well afatinib works in controlling cancer and improving quality of life for patients with Fanconi anemia. Researchers will monitor the duration of treatment effects, overall survival, and any changes in health-related quality of life.
Investigational drugs: Afatinib is taken orally as film-coated tablets. It works by inhibiting certain proteins that promote cancer cell growth, specifically targeting the epidermal growth factor receptor and related pathways.
Study of carboplatin, paclitaxel, and tislelizumab treatment in patients with resectable locally advanced oral cavity squamous cell carcinoma
This trial tests a combination of three medications given before surgery for patients with locally advanced oral cavity cancer that can be surgically removed. The treatment combines immunotherapy with chemotherapy to see how well the combination works in shrinking tumors before surgery.
Main inclusion criteria: Participants must be at least 18 years old with Stage III-IV oral cavity cancer confirmed by tissue examination. The cancer must be suitable for surgery with intent to cure and must meet specific biological markers. Good physical function is required, with ECOG status of 0-1, meaning patients can perform daily activities. Adequate organ and blood function is necessary, including normal white blood cell counts, hemoglobin levels, platelet counts, and liver and kidney function.
Main exclusion criteria: Patients who have had previous treatment for oral cavity cancer cannot participate. Those with active autoimmune disease, uncontrolled heart disease, active infections, or cancer spread to other parts of the body are excluded. Pregnant or breastfeeding women, those with known allergic reactions to study medications, or those who had major surgery within 4 weeks before the study are not eligible.
Main focus: The study aims to evaluate how well the combination of tislelizumab, carboplatin, and paclitaxel works in treating locally advanced oral cavity cancer before surgery. Researchers will examine how much cancer remains after treatment and monitor safety and effectiveness.
Investigational drugs: Carboplatin and paclitaxel are chemotherapy medications given through intravenous infusion that stop cancer cells from growing and dividing. Tislelizumab is an immunotherapy drug that helps the body’s immune system fight cancer by blocking a protein called PD-1.
Study on Detecting Sentinel Lymph Nodes in Early Oral Cancer Using Gallium-68-Tilmanocept and Technetium-99m in Patients with Oral Cancer
This trial focuses on improving the detection of sentinel lymph nodes in patients with early-stage oral cancer. The study compares a new imaging technique using Gallium-68-Tilmanocept PET/CT with the traditional method using Technetium-99m to determine which is more accurate.
Main inclusion criteria: Participants must be at least 18 years old with primary oral cancer located in specific areas of the mouth. The cancer must be classified as T1-T2 or small T3 stage with no spread to lymph nodes confirmed by ultrasound-guided fine needle aspiration within 30 days. Patients must be candidates for surgical removal through the mouth. Good performance status is required, with ECOG Grade 0-2, meaning patients can perform daily activities with varying levels of independence.
Main exclusion criteria: Patients with other types of cancer or who have had previous treatment for oral cancer cannot participate. Those with severe medical conditions, pregnant or breastfeeding women, and individuals unable to give informed consent are excluded. Patients participating in another clinical trial simultaneously or with a history of drug or alcohol abuse are not eligible.
Main focus: The study aims to determine which imaging method is more accurate at detecting sentinel lymph nodes before surgery. This information could help doctors better plan treatment and improve outcomes for patients with early oral cancer.
Investigational drugs: Gallium-68-Tilmanocept is a special imaging agent that helps doctors see lymph nodes more clearly during PET/CT scans. It binds to specific proteins in lymphatic tissue, allowing the lymph nodes to be highlighted during imaging to identify where cancer might spread first.
Study of Durvalumab, Tremelimumab, and Cisplatin for Patients with Resectable, Locally Advanced Squamous Cell Carcinoma of the Oral Cavity
This study investigates the effects of two immunotherapy medications, durvalumab and tremelimumab, in treating oral cavity cancer. The trial compares using durvalumab alone versus a combination of durvalumab and tremelimumab, with some participants receiving a placebo.
Main inclusion criteria: Participants must be at least 18 years old with newly diagnosed, resectable locally advanced stage IV oral cavity cancer confirmed through tissue examination. Patients must not have had any prior systemic therapy or radiation therapy in the head and neck area. An ECOG performance status of 0 or 1 is required, meaning patients can perform daily activities with minimal or no restrictions. Adequate organ and bone marrow function is necessary, and patients must weigh more than 30 kg.
Main exclusion criteria: Patients with an active second cancer in the last five years, active autoimmune disease requiring treatment, or history of organ transplantation are excluded. Those with active hepatitis B, hepatitis C, HIV, or AIDS cannot participate. Pregnant or breastfeeding women, those with known allergies to study medications, or those who received a live vaccine within 30 days before the study are not eligible.
Main focus: The trial monitors the biological response of tumors to these immunotherapy treatments, including any changes in tumor size or behavior. The study assesses the safety of the treatments and their impact on participants’ overall health.
Investigational drugs: Durvalumab and tremelimumab are both immunotherapy medications given through intravenous infusion. Durvalumab blocks a protein called PD-L1, while tremelimumab targets a protein called CTLA-4, both helping the immune system recognize and attack cancer cells more effectively.
Study of Pembrolizumab with Lenvatinib after Chemoradiation Treatment in Patients with Locally Advanced Head and Neck Cancer who are PD-L1 Positive
This trial examines whether combining pembrolizumab with lenvatinib works better than pembrolizumab alone in preventing cancer from returning after patients complete their initial treatment with chemotherapy and radiation therapy.
Main inclusion criteria: Participants must be at least 18 years old with locally advanced head and neck cancer (stage III-IVB) confirmed through tissue examination. The tumor must test positive for PD-L1 with a score of 1 or higher. Patients must have completed combined radiation therapy of at least 68 Gray with at least 200mg/m² of cisplatin chemotherapy. Good physical function is required, with ability to carry out daily activities with minimal or no restrictions.
Main exclusion criteria: Patients with a history of other cancers in the past 5 years, known active brain metastases, autoimmune diseases requiring treatment, or history of organ transplantation are excluded. Those with active hepatitis B or C, HIV infection, uncontrolled high blood pressure, serious heart conditions, or active bleeding problems cannot participate. Pregnant or breastfeeding women and those with known allergies to study medications are not eligible.
Main focus: The study aims to determine if using both pembrolizumab and lenvatinib together prevents cancer from returning more effectively than pembrolizumab alone. The treatment period may last up to 47 weeks, with regular medical check-ups to monitor health and treatment effectiveness.
Investigational drugs: Pembrolizumab is an immunotherapy medication given through intravenous infusion that blocks the PD-1 receptor to help the immune system fight cancer. Lenvatinib is taken as oral capsules and works as a targeted therapy that blocks proteins cancer cells need to grow and create new blood vessels.
Summary
The six ongoing clinical trials for squamous cell carcinoma of the oral cavity represent diverse approaches to treating this disease at different stages. Germany leads in trial availability with three studies, followed by Spain with participation in two trials, while Belgium, Italy, and the Netherlands each host one trial.
A notable trend is the strong focus on immunotherapy approaches, with pembrolizumab appearing in three different trials and other immune checkpoint inhibitors like durvalumab, tremelimumab, and tislelizumab being tested. Most trials combine immunotherapy with either chemotherapy or targeted therapies, reflecting the current direction in cancer treatment toward combination approaches.
The trials cover various disease stages, from early detection methods to treatment of advanced and recurrent disease. One study specifically addresses patients with Fanconi anemia, a rare genetic disorder that increases cancer risk, demonstrating attention to special patient populations. The variety of treatment approaches and patient populations covered by these trials provides options for patients at different stages of their disease journey across multiple European countries.
