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Ongoing Clinical Trials for Transitional Cell Carcinoma Urethra

Transitional cell carcinoma of the urethra, also known as urothelial carcinoma, is being studied in four ongoing clinical trials across Europe. These trials are testing combinations of immunotherapy drugs and antibody-drug conjugates to find more effective treatments for patients with advanced or metastatic disease. The studies are taking place in multiple European countries and are comparing new treatment approaches with standard chemotherapy.

Clinical trial locations

Study Comparing Sacituzumab Govitecan with Other Treatments for Patients with Advanced Unresectable Urothelial Cancer

This trial is comparing the effectiveness of sacituzumab govitecan, an antibody-drug conjugate, with standard chemotherapy treatments for patients with advanced urothelial cancer that cannot be surgically removed or has spread to other parts of the body.

Main inclusion criteria: Participants must be 18 years or older with confirmed urothelial cancer that is either metastatic or cannot be removed by surgery. The cancer must have worsened or returned after previous treatment with platinum-containing chemotherapy and anti-PD-1/PD-L1 therapy. Participants need to have an ECOG performance status of 0 or 1, meaning they can perform daily activities with minimal to no restrictions. Adequate blood counts, liver function, and kidney function are also required.

Main exclusion criteria: Patients with other types of cancer that are not urothelial cancer cannot participate. Those who have received different cancer treatment within the last 4 weeks, have severe heart problems, uncontrolled infections, or are pregnant or breastfeeding are also excluded. Patients with significant liver or kidney disease or a history of severe allergic reactions to similar drugs are not eligible.

Trial focus: The study aims to determine whether sacituzumab govitecan can help patients live longer compared to doctor-selected chemotherapy treatments such as docetaxel, vinflunine, or paclitaxel. All treatments are given as intravenous infusions. The research will monitor overall survival and other health outcomes to understand which treatment approach may be most effective for advanced urothelial cancer.

Investigational drug: Sacituzumab govitecan is an antibody-drug conjugate designed to target and kill cancer cells by delivering a powerful drug directly to them, while attempting to minimize damage to healthy cells.

Study of Enfortumab Vedotin and Pembrolizumab for Patients with Advanced or Metastatic Urothelial Cancer

This trial is testing the combination of enfortumab vedotin and pembrolizumab compared to standard chemotherapy in patients who have not previously received treatment for their advanced or metastatic urothelial cancer.

Main inclusion criteria: Participants must be 18 years or older with histologically documented urothelial cancer that is locally advanced or metastatic. The cancer must be measurable using specific guidelines, and participants need to have an ECOG performance status of 0, 1, or 2. For certain groups, patients must be eligible for platinum-based chemotherapy and have not received prior treatment for advanced cancer, while other groups may be ineligible for cisplatin due to reduced kidney function or heart problems. Adequate blood and organ function is required, as is the provision of tumor samples for analysis.

Main exclusion criteria: Patients with cancer types other than urothelial cancer, those outside the specified age range, or those unable to provide informed consent are excluded. Patients who are pregnant, breastfeeding, currently participating in another clinical trial, recovering from recent major surgery, or have a history of severe allergic reactions to the study drugs cannot participate.

Trial focus: The study will compare the effectiveness of the combination therapy of enfortumab vedotin and pembrolizumab with standard chemotherapy options including gemcitabine with either cisplatin or carboplatin. The goal is to evaluate overall survival rates and treatment response in patients with advanced urothelial cancer who have not received prior systemic treatment.

Investigational drugs: Enfortumab vedotin is an antibody-drug conjugate that targets a protein on cancer cells to deliver a toxic agent. Pembrolizumab is an immunotherapy drug that blocks a protein on cancer cells, allowing the immune system to recognize and attack them. The standard chemotherapy drugs gemcitabine, cisplatin, and carboplatin work by interfering with cancer cell DNA to prevent growth and division.

Study on Enfortumab Vedotin and Pembrolizumab for Patients with Advanced Urothelial Cancer

This trial is investigating enfortumab vedotin both alone and in combination with pembrolizumab for patients with various stages of urothelial cancer, including locally advanced, metastatic, and muscle-invasive disease.

Main inclusion criteria: Participants must have urothelial cancer that is either locally advanced, metastatic, or muscle-invasive, confirmed by tissue examination. Different groups have specific requirements: some must be eligible for platinum-based chemotherapy with no prior treatment for advanced cancer, while others must be ineligible for cisplatin due to health conditions like reduced kidney function or heart problems. Patients must have an ECOG performance status of 0, 1, or 2, a life expectancy of at least 3 months, and be willing to provide tumor samples. For muscle-invasive bladder cancer, patients must be eligible for surgical procedures including radical cystectomy and pelvic lymph node dissection. Age requirements are between 18 and 65 years.

Main exclusion criteria: Patients with cancer types other than urothelial cancer, those outside the age range, or unable to provide informed consent are excluded. Certain unspecified medical conditions that might interfere with the study, pregnancy, breastfeeding, participation in another clinical trial, recent major surgery, and history of severe allergic reactions to study drugs all prevent participation.

Trial focus: The study assesses the safety, tolerability, and effectiveness of enfortumab vedotin when used alone or combined with pembrolizumab. The research aims to determine how well these treatments reduce or eliminate cancer cells in patients with various stages of urothelial cancer. The trial will continue until August 2026.

Investigational drugs: Enfortumab vedotin is administered intravenously and works by targeting a protein on cancer cells to deliver a toxic agent that disrupts their growth. Pembrolizumab is used in combination with enfortumab vedotin to help the immune system recognize and attack cancer cells.

Study on the Safety and Effects of XL092 with Nivolumab, Ipilimumab, and Relatlimab for Patients with Advanced Solid Tumors

This trial is studying the combination of zanzalintinib with various immunotherapy drugs including nivolumab, ipilimumab, and relatlimab for patients with different types of advanced solid tumors, including urothelial carcinoma.

Main inclusion criteria: Patients must have a solid tumor that cannot be removed by surgery, is locally advanced, or has spread to other parts of the body. For most groups, the tumor must be measurable using RECIST 1.1 guidelines. Patients should provide tumor tissue samples and must have recovered from side effects of previous treatments. They must be 18 years or older with a Karnofsky Performance Status of 70% or higher, indicating reasonable ability to perform daily activities. Adequate organ and bone marrow function is required, and patients must understand study requirements and agree to participate. Those who are sexually active and able to have children must use effective birth control.

Main exclusion criteria: Patients with cancer types not specified in the study, those who have not received required previous treatments, and those with certain health conditions that might interfere with treatment are excluded. Patients unable to follow study procedures, those who are pregnant or breastfeeding, recent participants in other trials, and those with allergies to study medications cannot participate. Various histories of uncontrolled infections, heart, lung, liver, kidney, blood, immune system, neurological, or psychiatric conditions also prevent participation, as does substance abuse or inability to provide informed consent.

Trial focus: The study aims to determine the best dose of zanzalintinib when combined with immunotherapy drugs and to assess the safety and effectiveness of these combinations. The trial includes a dose-escalation stage to find the recommended dose and an expansion stage to evaluate preliminary effectiveness. The research will continue until December 2030, monitoring how well the treatment combinations work against various types of cancer.

Investigational drugs: XL092 (zanzalintinib) is an oral medication that inhibits specific molecular pathways promoting tumor growth. Nivolumab and ipilimumab are immunotherapy drugs that help the immune system recognize and attack cancer cells. Relatlimab is used as a fixed-dose combination with nivolumab to enhance immune response using two different mechanisms.

Summary

Four clinical trials are currently ongoing for transitional cell carcinoma of the urethra across Europe. The trials are concentrated primarily in Western European countries, with France, Belgium, Germany, Italy, and Spain hosting multiple studies. The research focuses heavily on immunotherapy combinations, particularly those involving pembrolizumab and nivolumab, alongside antibody-drug conjugates like enfortumab vedotin and sacituzumab govitecan.

Three of the four trials specifically target urothelial cancer, while one broader study includes this condition among several other advanced solid tumors. The combination of enfortumab vedotin and pembrolizumab appears in two separate trials, suggesting significant research interest in this particular treatment approach. Most trials are comparing these newer combination therapies with standard platinum-based chemotherapy to determine whether they offer improved survival outcomes for patients with advanced or metastatic disease.

The studies include patients at various stages of disease progression, from those who have not received prior treatment to those whose cancer has progressed after multiple lines of therapy. This range provides opportunities for patients at different points in their treatment journey to access potentially beneficial clinical trials across multiple European countries.

Ongoing Clinical Trials on Transitional cell carcinoma urethra

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