Head and neck cancer stage IV Trials in Disease

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

This trial is testing different combinations of cancer treatments for patients with advanced or metastatic solid tumors, including squamous cell carcinoma of the head and neck. The study explores how well tisotumab vedotin works alone or when combined with other medications.

Inclusion criteria: Participants must have relapsed, locally-advanced, or metastatic cancer, including squamous cell carcinoma of the head and neck, that has not responded to previous treatments and cannot be treated with standard therapy. For patients with this type of head and neck cancer, the disease must have gotten worse after the most recent treatment, and they should have had no more than 1 or 2 previous treatments for cancer that has returned or spread. The cancer must be measurable in size according to specific guidelines. Patients must also have a Combined Positive Score (CPS) of 1 or more, which measures a protein called PD-L1 in cancer cells. A tissue sample for testing is required, either from a recent biopsy or one taken within the last 2 years. Both men and women of adult age can participate.

Exclusion criteria: Patients with a different type of cancer that is not a solid tumor are not eligible. Solid tumors are masses of tissue that do not include liquid areas or cysts. Those who have not been diagnosed with locally advanced or metastatic disease cannot participate. Patients outside the specified age range, those unable to follow study procedures, or those who do not agree to participate are also excluded. Additionally, patients who are part of a vulnerable population not included in the study design cannot take part.

Focus and goals: The main purpose of this trial is to assess the antitumor activity of tisotumab vedotin and its combinations in treating advanced cancers. The study monitors how tumors respond to treatment, how long it takes for a response to occur, and the overall survival of patients. The trial is divided into several parts where tisotumab vedotin is given alone or combined with pembrolizumab, which helps the immune system fight cancer, and platinum agents like cisplatin or carboplatin, which are types of chemotherapy drugs. These medications are given through an intravenous infusion, meaning they are delivered directly into the bloodstream through a vein. Regular monitoring includes imaging tests and other evaluations to measure tumor size and progression.

Investigational drugs: Tisotumab vedotin is an experimental medication being studied for its ability to fight cancer. It is an antibody-drug conjugate that delivers a chemotherapy drug directly to cancer cells by targeting a specific protein on their surface. Pembrolizumab is used in combination with tisotumab vedotin to help the immune system attack cancer cells. Platinum agents, such as cisplatin or carboplatin, are chemotherapy drugs that damage the DNA of cancer cells to help stop their growth. The study evaluates whether these combinations can enhance treatment effectiveness.

Summary

There is currently one ongoing clinical trial available for patients with Stage IV head and neck cancer. This trial is being conducted across four European countries: France, Germany, Italy, and Spain. The study focuses on evaluating the combination of tisotumab vedotin, pembrolizumab, and platinum-based chemotherapy agents as a potential treatment approach for patients with advanced or metastatic solid tumors, including squamous cell carcinoma of the head and neck.

The trial is particularly notable for its investigation of tisotumab vedotin, an antibody-drug conjugate that is still in the experimental phase. The study aims to determine whether combining this new medication with established cancer treatments like pembrolizumab and platinum agents can improve outcomes for patients whose cancer has not responded to previous therapies. Patients interested in participating should have experienced disease progression after their most recent treatment and have limited prior treatment history.