In short

There are currently 4 ongoing clinical trials investigating new treatments for metastatic head and neck cancer. These studies are evaluating various immunotherapy medications, either alone or in combination with other treatments such as chemotherapy or radiation therapy. The trials are being conducted across multiple European countries including Belgium, Denmark, France, Germany, Greece, Italy, Portugal, Romania, and Spain.

Clinical trial locations

Belgium
- Study of eftilagimod alpha with pembrolizumab combination therapy for patients with metastatic head and neck cancer who have not received previous treatment
Denmark
- Study of eftilagimod alpha with pembrolizumab combination therapy for patients with metastatic head and neck cancer who have not received previous treatment
France
Germany
- Study of eftilagimod alpha with pembrolizumab combination therapy for patients with metastatic head and neck cancer who have not received previous treatment
- Study of Tisotumab Vedotin, Pembrolizumab, and Platinum Drug Combination for Patients with Advanced or Metastatic Solid Tumors
Greece
- Study of Retifanlimab, INCAGN02385, and INCAGN02390 for First-Line Treatment in Patients with PD-L1 Positive Recurrent/Metastatic Head and Neck Cancer
Italy
- Study of Retifanlimab, INCAGN02385, and INCAGN02390 for First-Line Treatment in Patients with PD-L1 Positive Recurrent/Metastatic Head and Neck Cancer
- Study of Tisotumab Vedotin, Pembrolizumab, and Platinum Drug Combination for Patients with Advanced or Metastatic Solid Tumors
Portugal
- Study of Retifanlimab, INCAGN02385, and INCAGN02390 for First-Line Treatment in Patients with PD-L1 Positive Recurrent/Metastatic Head and Neck Cancer
Romania
- Study of eftilagimod alpha with pembrolizumab combination therapy for patients with metastatic head and neck cancer who have not received previous treatment
Spain

Study of eftilagimod alpha with pembrolizumab combination therapy for patients with metastatic head and neck cancer who have not received previous treatment

This trial examines a combination therapy approach for patients with metastatic head and neck squamous cell carcinoma that has spread beyond its original location. The study compares two treatment approaches: pembrolizumab alone versus pembrolizumab combined with eftilagimod alfa.

Main inclusion criteria: Participants must be at least 18 years old with measurable cancer that has spread and cannot be cured with local treatments. Adequate organ function is required, demonstrated through blood tests showing sufficient white blood cells, platelets, hemoglobin, and normal kidney and liver function. A tissue sample must be provided for testing specific markers. Good physical function is necessary, with participants able to perform daily activities. Women of childbearing age must have a negative pregnancy test and use effective birth control during the study and for 4 months afterwards.

Main exclusion criteria: Patients who have previously received anti-PD-1, anti-PD-L1, or anti-PD-L2 immunotherapy cannot participate. Active brain metastases, uncontrolled medical conditions such as severe heart disease or high blood pressure, and active infections exclude participation. Known autoimmune disease is generally excluded, though controlled conditions like type 1 diabetes or thyroid disorders may be acceptable. Pregnant or breastfeeding women, those with certain viral infections, and participation in other clinical trials are not permitted.

Study focus: The trial evaluates how well the combination of pembrolizumab and eftilagimod alfa works together in treating this cancer compared to pembrolizumab alone. Treatment can last up to 24 months, with pembrolizumab given through intravenous infusion and eftilagimod alfa administered as a subcutaneous injection. The study monitors cancer response through regular medical examinations and imaging tests.

Investigational drugs: Eftilagimod alpha is a soluble LAG-3 fusion protein that helps activate the immune system to fight cancer cells. Pembrolizumab is an immunotherapy medication that blocks certain proteins, helping the immune system recognize and attack cancer cells. Both medications work by boosting the body's natural defense mechanisms.

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

This double-blind clinical trial investigates treatment options for recurrent or metastatic squamous cell carcinoma that is positive for the PD-L1 protein. The study tests combinations of retifanlimab with other investigational drugs.

Main inclusion criteria: Participants must be 18 years or older with confirmed diagnosis of cancer that has returned or spread and cannot be treated with curative surgery or radiation. The tumor must test positive for PD-L1 as determined by a central laboratory. At least one measurable tumor according to specific medical guidelines is required. Available tissue samples from a previous biopsy are needed, or participants must be willing to undergo a new biopsy. Patients must be fully active or have some symptoms but can carry out light work.

Main exclusion criteria: Patients who have already received systemic therapy for their condition cannot participate. Those without PD-L1 positive status, outside the specified age range, or considered part of vulnerable populations are excluded.

Study focus: The trial evaluates the safety and effectiveness of retifanlimab alone compared to combinations with INCAGN02385 and INCAGN02390. All medications are administered through intravenous infusion. Neither participants nor researchers know which treatment each participant receives during the study, which can last up to 24 months. Regular check-ups include physical exams, blood tests, and imaging to monitor cancer progression and treatment effects.

Investigational drugs: Retifanlimab is an immune checkpoint inhibitor that helps the body's immune system recognize and attack cancer cells. INCAGN02385 targets the LAG-3 protein to prevent it from interfering with immune system function against cancer. INCAGN02390 blocks the TIM-3 protein, potentially enhancing the immune response against cancer cells.

Study of Tisotumab Vedotin, Pembrolizumab, and Platinum Drug Combination for Patients with Advanced or Metastatic Solid Tumors

This study evaluates tisotumab vedotin for patients with locally advanced or metastatic solid tumors, including squamous cell carcinoma of the head and neck. The trial examines the medication both alone and in various combinations.

Main inclusion criteria: Patients must have relapsed, locally advanced, or metastatic cancer that has not responded to previous treatments and cannot be treated with standard therapy. For patients with head and neck cancer, disease progression must have occurred after the most recent treatment, with no more than 1 or 2 previous treatments. Measurable disease according to specific guidelines is required. Patients with head and neck cancer must have a Combined Positive Score of 1 or more for the PD-L1 protein. A tissue sample for testing must be provided, either recent or taken within the last 2 years.

Main exclusion criteria: Patients with cancers that are not solid tumors, those without locally advanced or metastatic disease, individuals outside the specified age range, those unable to follow study procedures, or members of vulnerable populations not included in the study design cannot participate.

Study focus: The trial assesses the antitumor activity of tisotumab vedotin alone and in combination with pembrolizumab and platinum agents like cisplatin or carboplatin. All medications are administered intravenously. The study monitors tumor response, time to response, and overall survival to determine treatment effectiveness and safety.

Investigational drugs: Tisotumab vedotin is an antibody-drug conjugate that delivers a cytotoxic agent directly to cancer cells by targeting a specific surface protein. Pembrolizumab helps the immune system attack cancer cells. Platinum agents are chemotherapy drugs that damage cancer cell DNA to stop their growth.

Study on the Safety and Effects of Durvalumab and Tremelimumab with Radiotherapy for Patients with Metastatic Squamous Cell Carcinoma

This trial tests a combination of immunotherapy medications with precise radiation therapy for metastatic squamous cell carcinoma, including cancer of the head and neck. The study has two phases focusing on safety and effectiveness.

Main inclusion criteria: Patients must be 18 years or older with adequate organ function, including sufficient neutrophils, platelets, hemoglobin levels, normal liver enzymes, and proper kidney function. Participants must have confirmed diagnosis of metastatic squamous cell carcinoma that has been previously treated. At least one tumor suitable for radiation treatment and another that will not receive radiation are required. One tumor must be accessible for biopsy both before and after treatment. Previously collected tumor samples must be available, and tumors must be measurable according to specific criteria. Patients must not have had radiation therapy in the area to be treated and must have a performance status indicating they are fully active or have some restrictions but can still do light work.

Main exclusion criteria: Previous history of other cancers (except certain treated skin cancers), active infections requiring antibiotics, severe allergic reactions to similar medications, pregnancy or breastfeeding, autoimmune disease, recent live vaccines, serious heart conditions, uncontrolled high blood pressure, recent drug or alcohol abuse, and current participation in another clinical trial all exclude participation.

Study focus: The trial evaluates the safety and clinical activity of durvalumab and tremelimumab when combined with stereotactic body radiotherapy. This precise radiation treatment targets tumors while minimizing damage to healthy tissue. Throughout the study, participants undergo various medical assessments including imaging tests to track cancer progress and treatment response.

Investigational drugs: Durvalumab blocks the PD-L1 protein, helping the immune system recognize and destroy cancer cells. Tremelimumab inhibits the CTLA-4 protein, enhancing the immune system's ability to attack cancer cells. Both medications are administered intravenously in combination with stereotactic body radiotherapy to enhance treatment effectiveness.

Summary

The four ongoing clinical trials for metastatic head and neck cancer demonstrate a strong focus on immunotherapy approaches, with all studies incorporating medications that work by enhancing the body's immune system to fight cancer cells. Most trials are evaluating combination therapies rather than single treatments, reflecting current research trends in oncology.

Geographically, these trials show a concentration in Western European countries, particularly France and Spain, which each host three of the four trials. Germany and Italy each participate in two trials, while Belgium, Denmark, Greece, Portugal, and Romania each host one trial. This distribution suggests robust clinical research infrastructure in these countries for cancer treatment studies.

A notable pattern across the trials is the emphasis on PD-1 and PD-L1 pathway inhibitors, with pembrolizumab appearing in three of the four studies. Other immune checkpoint inhibitors such as retifanlimab and durvalumab are also being investigated. Several trials explore combinations with additional immunotherapy agents targeting different pathways, including LAG-3, TIM-3, and CTLA-4 proteins, suggesting researchers are investigating whether blocking multiple immune checkpoints simultaneously may improve treatment outcomes.

The trials generally require participants to have adequate organ function, good performance status, and in most cases, no previous treatment with similar immunotherapy medications. Treatment duration typically extends up to 24 months, with regular monitoring through imaging tests and physical examinations. All studies emphasize patient safety monitoring alongside effectiveness evaluation, reflecting the experimental nature of these treatment combinations.

Head and neck cancer metastatic Trials in Disease

Clinical trials for Head and neck cancer metastatic