Head and neck cancer stage III Trials in Disease

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

This clinical trial is investigating the effectiveness of tisotumab vedotin, either alone or in combination with other cancer-fighting medications, for patients with advanced solid tumors. The study specifically includes patients with squamous cell carcinoma of the head and neck, among other cancer types.

Main inclusion criteria:

• Patients must have cancer that has returned, spread to nearby areas, or spread to other parts of the body and has not responded to previous treatments.
• For head and neck cancer patients specifically, the cancer must have gotten worse after their most recent treatment.
• Patients should have had no more than 1 or 2 previous treatments for cancer that has come back or spread.
• The cancer must be measurable, meaning doctors can track its size using medical imaging.
• For certain parts of the study, patients need to have a Combined Positive Score (CPS) of 1 or higher, which measures a specific protein called PD-L1 in cancer cells.
• Patients must be able to provide a tissue sample for testing, either from a recent biopsy or one taken within the last 2 years.
• Both men and women who are adults can participate.

Main exclusion criteria:

• Patients with cancer that is not a solid tumor.
• Patients whose cancer has not spread locally or to other parts of the body.
• Patients outside the specified age range for the study.
• Patients who cannot follow study procedures or do not agree to participate.
• Patients who are part of vulnerable populations not included in the study design.

Focus and goal of the trial:

The study aims to evaluate how well tisotumab vedotin works against cancer, both on its own and when combined with pembrolizumab and platinum-based chemotherapy drugs like cisplatin or carboplatin. The medications are given through intravenous infusion directly into the bloodstream. Researchers will monitor how tumors respond to treatment, how long it takes to see a response, and the overall survival of patients. The study is divided into several parts, with different treatment combinations being tested in each part.

Investigational drugs:

The trial uses three main types of medications:

• Tisotumab vedotin is an antibody-drug conjugate that delivers chemotherapy directly to cancer cells by targeting a specific protein on their surface. This helps to stop cancer cells from growing and spreading.
• Pembrolizumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells more effectively.
• Platinum agents (such as cisplatin or carboplatin) are traditional chemotherapy drugs that damage the DNA of cancer cells, helping to stop their growth.

Participants will undergo regular monitoring throughout the study, including imaging tests to measure tumor size and check for disease progression. The study will also track any side effects that patients may experience from the treatments.