Clinical trial locations
- Belgium
- Germany
- Italy
- Slovakia
- Spain
Study on Niraparib and Dostarlimab for Patients with HPV-Negative Head and Neck Squamous Cell Carcinoma
This trial is investigating a combination treatment approach for patients with HPV-negative oropharyngeal cancer. The study tests two medications: niraparib, a tablet taken by mouth, and dostarlimab, given through a vein infusion.
Main inclusion criteria: Patients must have HPV-negative squamous cell carcinoma that can be removed with surgery, with cancer at stage III-IV that has not spread to distant body parts. Patients need good overall health status, normal organ function including blood counts and kidney/liver function, and the ability to swallow tablets. Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for 180 days afterward.
Main exclusion criteria: Patients with HPV-positive cancer cannot participate. Those outside the specified age range, not meeting clinical trial group criteria, or considered part of vulnerable populations are also excluded.
Trial focus: The study evaluates how effectively this combination prevents cancer cells from repairing themselves, potentially leading to their destruction. The trial includes three phases: an induction phase with both medications, surgery to remove the tumor, and a maintenance phase with continued niraparib treatment. Throughout the study, regular monitoring includes check-ups and imaging tests like MRI to assess cancer response.
Investigational drugs: The study uses a PARP inhibitor (niraparib) that blocks an enzyme cells use for DNA repair, combined with immunotherapy (dostarlimab) that helps the immune system recognize and attack cancer cells more effectively.
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 studies afatinib in patients with Fanconi anemia who have developed advanced cancer in the mouth, throat, or voice box areas that cannot be surgically removed or has spread to other body parts.
Main inclusion criteria: Patients must provide written informed consent and have ECOG performance status less than 2. They need adequate organ and bone marrow function including specific levels of neutrophils, platelets, hemoglobin, and normal kidney and liver function tests. Female patients must be of non-childbearing potential or agree to pregnancy prevention during the study. Male patients must agree to contraception measures. Patients must be at least 18 years old with confirmed Fanconi anemia diagnosis and unresectable or locoregionally advanced squamous cell carcinoma. They must have at least one measurable tumor lesion and not be candidates for standard curative treatments.
Main exclusion criteria: Patients without unresectable or metastatic locoregionally advanced cancer, those without Fanconi anemia, patients outside the specified age range, those not in specified trial groups, and those not male or female are excluded.
Trial focus: The study evaluates afatinib's safety and effectiveness in controlling these cancers and improving quality of life. Different dosages will be compared, with monitoring for side effects and cancer response over time. The trial will assess treatment duration effects, overall survival, and health-related quality of life changes.
Investigational drugs: Afatinib is taken orally as film-coated tablets and works by blocking certain proteins that promote cancer cell growth, specifically targeting the epidermal growth factor receptor and related pathways. It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.
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 recurrence after patients complete initial chemotherapy and radiation treatment.
Main inclusion criteria: Patients must be adults 18 years or older with locally advanced stage III-IVB cancer confirmed through tissue examination. Their tumors must test positive for PD-L1 protein with a score of 1 or higher. Patients must have completed combined radiation (at least 68 Gray) and chemotherapy (at least 200mg/m² cisplatin) without cancer growth or spread during treatment. They must have good physical function, being either fully active or able to carry out light work.
Main exclusion criteria: History of other cancers in the past 5 years (except successfully treated non-melanoma skin cancer or cervical cancer), active brain metastases or brain/spinal cord disease, autoimmune diseases requiring systemic treatment, organ transplantation history, active hepatitis B or C, HIV infection or AIDS, uncontrolled high blood pressure, serious heart conditions including recent heart attack, active bleeding problems or blood-thinning medication use, pregnancy or breastfeeding, known medication allergies, recent participation in other trials, mental conditions interfering with study procedures, or any serious medical condition compromising patient safety are excluded.
Trial focus: The treatment period may last up to 2 years. Patients receive either pembrolizumab alone through intravenous infusion or pembrolizumab infusion plus lenvatinib capsules taken by mouth. Regular medical check-ups monitor health status, with imaging tests evaluating cancer response to treatment.
Investigational drugs: Pembrolizumab is an immunotherapy medication that blocks the PD-L1 protein, helping the immune system recognize and attack cancer cells more effectively. Lenvatinib is a targeted therapy that blocks cancer cell growth and spread by interfering with proteins cancer cells need to grow and create new blood vessels.
Summary
These five clinical trials represent diverse approaches to treating oropharyngeal squamous cell carcinoma across multiple European countries. A notable pattern is the focus on HPV status, with separate trials for HPV-positive and HPV-negative cancers, reflecting the different biological characteristics and treatment responses of these cancer subtypes.
Immunotherapy features prominently in several studies, with trials investigating durvalumab, pembrolizumab, and dostarlimab, either alone or in combination with other treatments. This reflects the growing importance of harnessing the immune system to fight cancer. Several trials also explore treatment de-escalation strategies for HPV-positive cancers, aiming to maintain effectiveness while reducing side effects and improving quality of life.
The geographic distribution shows concentration in Western and Southern European countries, with trials in Italy, Spain, Germany, Belgium, and Slovakia. Some studies are multi-national, allowing for broader patient recruitment and potentially more generalizable results. The variety of investigational approaches—from traditional chemotherapy combinations to novel targeted therapies and immunotherapies—demonstrates the ongoing effort to improve outcomes for patients with this challenging cancer type.
Germany
