Pancreatic neoplasm Trials in Disease

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

This clinical trial is evaluating a new treatment approach for patients with advanced or metastatic solid tumors, including pancreatic cancer that has spread to other parts of the body or has grown into nearby tissues. The study tests tisotumab vedotin, a medication that delivers chemotherapy directly to cancer cells, both on its own and in combination with other cancer-fighting drugs.

Main inclusion criteria:

• Patients must have relapsed, locally-advanced, or metastatic colorectal or pancreatic cancer, squamous non-small cell lung cancer, or squamous cell carcinoma of the head and neck that has not responded to previous treatments and cannot be treated with standard therapy
• The cancer must be measurable according to specific medical guidelines, meaning doctors can track changes in tumor size
• 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
• For certain parts of the study involving head and neck cancer, patients must have a Combined Positive Score of 1 or more, which measures a specific protein in cancer cells

Main exclusion criteria:

• Patients with cancers that are not solid tumors are not eligible
• Patients whose cancer has not spread to nearby tissues or distant organs cannot participate
• Patients who fall outside the specified age range for the study
• Patients who are unable to follow study procedures or do not agree to participate
• Patients who belong to vulnerable populations that the study is not designed to include

Focus and goal of the trial:

The trial is divided into several parts, each testing different treatment combinations. Some patients will receive tisotumab vedotin alone, while others will receive it combined with pembrolizumab, an immunotherapy drug that helps the immune system fight cancer cells. A third group will receive all three medications together, including a platinum-based chemotherapy drug such as cisplatin or carboplatin.

All medications are given through intravenous infusion, which means they are delivered directly into the bloodstream through a vein. Throughout the study, doctors will closely monitor how the tumors respond to treatment, measuring changes in tumor size and tracking overall patient survival. The study will also assess any side effects that patients experience.

The main goal is to evaluate the antitumor activity of tisotumab vedotin and its combinations, determining how effective and safe these treatment options are for patients with advanced cancers that have not responded to standard therapies.

Investigational drugs:

• Tisotumab vedotin is an antibody-drug conjugate that combines a monoclonal antibody with a chemotherapy drug to target and destroy cancer cells more precisely
• Pembrolizumab is an immunotherapy medication that helps the immune system recognize and attack cancer cells
• Platinum agents such as cisplatin or carboplatin are chemotherapy drugs that damage the DNA of cancer cells, helping to stop their growth and spread

Summary

Currently, there is one active clinical trial for pancreatic neoplasm patients, focusing on those with advanced or metastatic disease. The trial is being conducted across four European countries: France, Germany, Italy, and Spain. This multi-country approach provides broader access to patients across Europe who have exhausted standard treatment options.

The trial takes an innovative approach by testing tisotumab vedotin, an experimental antibody-drug conjugate, both as a single treatment and in combination with established cancer therapies. The combination approach with pembrolizumab and platinum-based chemotherapy represents an attempt to enhance treatment effectiveness by targeting cancer through multiple mechanisms simultaneously.

This study specifically addresses an important medical need for patients whose cancer has not responded to previous treatments, offering a potential new treatment option through clinical research. Patients interested in participating should discuss eligibility with their healthcare provider to determine if this trial might be appropriate for their specific situation.