Enfortumab Vedotin for Advanced Cancer

This trial tests a new cancer treatment called enfortumab vedotin (also known as Padcev) to evaluate its effectiveness against several types of advanced cancers. The primary goal is to measure the treatment's ability to shrink tumors. The trial also assesses the treatment's safety and its impact on patient survival. Individuals with advanced cancers, such as certain types of breast, lung, head and neck, and stomach cancers, who have not responded to standard treatments, might be suitable candidates for this trial. Participants will receive the treatment through an IV infusion on specific days within a treatment cycle. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not participate in another interventional study while receiving treatment in this trial. It's best to discuss your current medications with the trial team to get a clear answer.

Research has shown that enfortumab vedotin, when used alone, has been studied in patients with advanced non-small cell lung cancer. The study found that the treatment was generally well-tolerated. Some patients experienced side effects like tiredness and skin rash, but these were usually manageable.

When combined with pembrolizumab, enfortumab vedotin has also been tested for bladder cancer. Studies have found that this combination reduces certain risks for patients, suggesting it is relatively safe. However, some common side effects included skin reactions and changes in taste.

Enfortumab vedotin is unique because it combines an antibody with a cancer-fighting agent, specifically targeting cancer cells while minimizing damage to healthy cells. Unlike traditional chemotherapy, which can affect both cancerous and healthy cells, enfortumab vedotin is designed to deliver its payload directly to the cancer cells, potentially reducing side effects. Researchers are particularly excited about its potential effectiveness in various cancers, such as breast and lung cancer, especially for patients who may not respond well to existing treatments like standard chemotherapies or targeted therapies. In some cases, like head and neck squamous cell carcinoma, it is used in combination with pembrolizumab, an immunotherapy, which may enhance its effectiveness by helping the immune system recognize and attack cancer cells.

Research has shown that enfortumab vedotin, which participants in this trial will receive, may be effective against various cancers. Different cohorts in this trial will study its effects on specific cancer types. For stomach and esophagus cancers, studies found that this treatment has promising effects, with patients living an average of 4 to 7 months longer. In hormone receptor-positive breast cancer, enfortumab vedotin showed some positive effects, although it didn't achieve all the trial's goals. In non-small cell lung cancer, both squamous and non-squamous types, some patients responded to the treatment, but these responses were less common. For head and neck cancer, the drug helped 24% of patients who had already tried many other treatments. Lastly, in triple-negative breast cancer, combining enfortumab vedotin with pembrolizumab significantly increased the number of patients who had a complete response compared to surgery alone. Overall, enfortumab vedotin shows potential in treating different types of cancer, offering hope for better outcomes.⁶⁷⁸⁹¹⁰