Ongoing Clinical Trials for Laryngeal Squamous Cell Carcinoma
Currently, there are 4 clinical trials underway examining new treatment approaches for laryngeal squamous cell carcinoma, a type of cancer affecting the voice box. These studies are exploring immunotherapy medications, targeted therapies, and advanced surgical techniques across multiple European countries including Germany, Spain, and the Netherlands.
Clinical trial locations
- 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
- Netherlands
- Spain
Study on Pembrolizumab and Drug Combination for Patients with Recurrent Head and Neck Cancer
This trial is examining treatment options for patients whose cancer has returned in the head and neck area after previous treatment. The study compares two approaches: one using sequential re-radiochemotherapy followed by pembrolizumab, and another using pembrolizumab with or without chemotherapy.
Main inclusion criteria: Participants must be at least 18 years old with confirmed recurrent head and neck squamous cell carcinoma that cannot be surgically removed or where surgery would cause significant functional problems. The cancer must have a PD-L1 combined positive score of 1 or more, and participants must have had prior radiation or combined radiation and chemotherapy treatment of the neck with at least a 6-month gap since the last treatment. Adequate 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 beyond recurrent head and neck squamous cell carcinoma are excluded. Those with severe or uncontrolled medical conditions, recent participation in other clinical trials, known allergies to study medications, or who are pregnant or breastfeeding cannot participate. Patients unable to follow study procedures or attend required visits may also be excluded.
Focus and goal: The trial aims to determine whether the new treatment sequence can improve overall survival compared to standard therapies. Participants receive treatments through intravenous infusion and are monitored regularly through physical examinations, blood tests, imaging studies, and questionnaires assessing tumor symptoms, swallowing function, and quality of life.
Investigational drugs: Pembrolizumab is an immunotherapy medication that helps the immune system fight cancer cells by blocking pathways that allow cancer to hide from immune cells. Re-radiochemotherapy combines radiation therapy with chemotherapy drugs including fluorouracil, carboplatin, and cisplatin to target and stop cancer cell growth.
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 affecting bone marrow that increases cancer risk, who have developed squamous cell carcinoma in areas including the larynx. The trial investigates whether afatinib can safely and effectively treat these cancers when they cannot be surgically removed or have spread.
Main inclusion criteria: Patients must be 18 years or older with confirmed Fanconi anemia and confirmed unresectable or locoregionally advanced squamous cell carcinoma in specified head and neck areas. They must have adequate organ and bone marrow function, including neutrophils greater than 1,000 cells per microliter, platelets greater than 50,000 cells per microliter, and hemoglobin greater than 8 grams per deciliter. Patients should have an ECOG performance status of less than 2, meaning they can carry out daily activities with minimal assistance. The tumor must not be suitable for surgical removal and must have at least one measurable lesion visible on CT or MRI scans.
Main exclusion criteria: Patients without the specified diagnosis of unresectable or metastatic squamous cell carcinoma in the designated areas, those without Fanconi anemia, and those outside the specified age range cannot participate.
Focus and goal: The study evaluates how well afatinib works in controlling cancer and improving quality of life for this specific patient group. Researchers will monitor treatment effectiveness through regular imaging tests and assess any side effects, with adjustments made to the treatment plan as necessary.
Investigational drugs: Afatinib is taken orally as film-coated tablets in strengths of 40 mg, 30 mg, or 20 mg. It is a tyrosine kinase inhibitor that works by blocking certain proteins that promote cancer cell growth, specifically targeting the epidermal growth factor receptor and related pathways.
Study on Fluorescence-Guided Surgery Using cRGD-ZW800-1 for Patients with Laryngeal and Hypopharyngeal Cancer
This innovative trial explores a new surgical technique using a fluorescent tracer called cRGD-ZW800-1 to help surgeons better identify and remove cancerous tissue during operations for laryngeal and hypopharyngeal cancer. The tracer makes cancer cells glow under special lights, potentially improving surgical accuracy.
Main inclusion criteria: Participants must be at least 18 years old with biopsy-confirmed squamous cell carcinoma of the larynx or hypopharynx. They must be eligible for surgical removal of the tumor and have sufficient knowledge of Dutch to understand the informed consent form.
Main exclusion criteria: Patients who do not have squamous cell carcinoma of the larynx or hypopharynx, those not undergoing total laryngectomy or pharyngectomy, patients outside the specified age range, and vulnerable populations unable to give consent are excluded.
Focus and goal: The study determines whether fluorescence imaging can help surgeons distinguish cancerous tissue from healthy tissue more effectively during throat cancer surgery. Before surgery, patients receive an intravenous infusion of cRGD-ZW800-1, and during the operation, surgeons use a special camera to see the glowing effect. Success is measured by the tumor-to-background ratio, with a value greater than 1.5 considered feasible, and by achieving clear resection margins with no cancerous tissue left behind.
Investigational drugs: The cRGD-ZW800-1 fluorescence imaging agent is a diagnostic tool administered intravenously that binds to cancer cells, causing them to emit a fluorescent signal when exposed to specific light, allowing better visualization during surgery.
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 combining pembrolizumab and lenvatinib works better than pembrolizumab alone in preventing cancer from returning in patients who have completed initial chemotherapy and radiation treatment for locally advanced head and neck cancer.
Main inclusion criteria: Participants must be adults aged 18 or older with locally advanced head and neck cancer stage III-IVB confirmed through tissue examination. Their tumors must test positive for PD-L1 with a score of 1 or higher. They must have completed combined radiation and chemotherapy treatment, including at least 68 Gray of radiation and at least 200mg/m² of cisplatin, with no cancer growth or spread during that treatment. Participants must have good physical function, being either fully active or able to carry out light work.
Main exclusion criteria: Patients with other malignant tumors in the past 5 years, active brain metastases, autoimmune diseases requiring systemic treatment, organ transplantation history, active hepatitis B or C, HIV infection, uncontrolled high blood pressure, serious heart conditions including recent heart attack, active bleeding problems, pregnancy or breastfeeding, known allergies to study medications, recent participation in other trials, or serious medical conditions compromising safety are excluded.
Focus and goal: The trial compares two treatment approaches: pembrolizumab alone given through intravenous infusion, or pembrolizumab through infusion combined with lenvatinib capsules taken by mouth. Treatment continues for up to 2 years with regular medical examinations, imaging tests to monitor cancer response, and monitoring of side effects.
Investigational drugs: Pembrolizumab is an immunotherapy medication that helps the immune system recognize and attack cancer cells by blocking the PD-L1 protein. Lenvatinib is a targeted therapy taken as oral capsules that blocks the growth and spread of cancer cells by interfering with proteins needed for tumor growth and blood vessel formation.
Summary
These four clinical trials represent diverse approaches to treating laryngeal squamous cell carcinoma and related head and neck cancers. Germany hosts the most trials with three studies, while Spain participates in one and the Netherlands conducts one focused on surgical innovation.
A notable pattern emerges in the focus on immunotherapy, particularly pembrolizumab, which appears in three of the four trials. This reflects current trends in cancer treatment where medications that enhance the immune system’s ability to fight cancer are being extensively studied. Two trials specifically examine combination approaches: one pairing pembrolizumab with lenvatinib, and another exploring pembrolizumab with or without chemotherapy following re-radiochemotherapy.
The trials address different clinical situations: recurrent cancer after previous treatment, advanced disease in patients with genetic disorders like Fanconi anemia, and cancer prevention after initial treatment. The Dutch study stands apart by exploring an entirely different approach using fluorescence-guided surgery to improve surgical precision.
Patient eligibility varies significantly across trials, with some requiring specific tumor characteristics such as PD-L1 positivity, while others focus on particular patient populations like those with Fanconi anemia. Most trials require participants to be at least 18 years old with adequate organ function and the ability to follow study procedures.
