Pancreatic carcinoma stage IV 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 new treatment options for patients with advanced or metastatic solid tumors, including pancreatic cancer that has spread to other parts of the body. The study examines how well tisotumab vedotin works, both on its own and when combined with other cancer-fighting medications.

Main inclusion criteria: Patients eligible for this study 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 its size through imaging tests. Patients must be able to provide a tissue sample for testing, either from a recent biopsy or one taken within the last two years. Both men and women of appropriate age ranges can participate in the study.

Main exclusion criteria: Patients cannot participate if they have a cancer that is not a solid tumor. Those who have not been diagnosed with locally advanced or metastatic disease are not eligible. Patients must be within the specified age range and able to follow study procedures. Those who do not agree to participate or are part of vulnerable populations not included in the study design are also excluded.

Focus and goal: The study aims to assess the antitumor activity of tisotumab vedotin and determine how effective these treatment combinations are in fighting advanced cancers. Researchers will monitor how tumors respond to the treatment, how long it takes for a response to occur, and the overall survival of patients. The trial is divided into several parts, with some patients receiving tisotumab vedotin alone, while others receive it alongside pembrolizumab or both pembrolizumab and a platinum-based chemotherapy drug like cisplatin or carboplatin. All medications are given through intravenous infusion, meaning they are delivered directly into the bloodstream through a vein. Participants undergo regular monitoring, including imaging tests and other evaluations, to measure tumor size and progression throughout the study.

Investigational drugs: The main drug being tested is tisotumab vedotin, an antibody-drug conjugate that delivers a chemotherapy agent directly to cancer cells by targeting a specific protein on their surface. This helps inhibit tumor growth and spread. Pembrolizumab is used in combination with tisotumab vedotin in some parts of the study. It works by helping the immune system recognize and attack cancer cells. The study also includes platinum agents, which are types of chemotherapy drugs containing platinum that damage the DNA of cancer cells to stop their growth. These drugs are being tested in various combinations to determine which approach offers the best results for patients with advanced solid tumors.

Summary

Currently, there is one clinical trial available for patients with Stage IV pancreatic carcinoma. This trial is being conducted in four European countries: France, Germany, Italy, and Spain, providing access to patients across multiple locations. The study focuses on evaluating tisotumab vedotin, a novel antibody-drug conjugate, both as a single treatment and in combination with pembrolizumab and platinum-based chemotherapy. This approach reflects a growing interest in combination therapies that use different mechanisms to fight cancer more effectively. Patients with advanced pancreatic cancer who have not responded to standard treatments may find this trial of interest, as it offers access to experimental medications that are not yet widely available in standard medical practice.