Clinical Trials for Malignant Urinary Tract Neoplasm
There are currently 4 ongoing clinical trials investigating new treatments for malignant urinary tract neoplasm. These studies are testing innovative immunotherapy approaches and combination treatments across multiple European countries, offering options for patients with advanced or metastatic disease who may not be suitable for standard chemotherapy or who have completed previous treatments.
Clinical trial locations
- Austria
- Belgium
- Bulgaria
- Czechia
- Denmark
- France
- Study for Patients with Lung or Urinary Tract Cancer Continuing Treatment with Durvalumab, Infliximab, and Mycophenolate Mofetil
- Study of BT8009 Alone or with Pembrolizumab for Patients with Advanced or Metastatic Bladder Cancer
- Study of Atezolizumab Treatment Before Surgery in Patients with Bladder Cancer or Upper Urinary Tract Cancer
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Latvia
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Spain
- Study for Patients with Lung or Urinary Tract Cancer Continuing Treatment with Durvalumab, Infliximab, and Mycophenolate Mofetil
- Study of BT8009 Alone or with Pembrolizumab for Patients with Advanced or Metastatic Bladder Cancer
- Study of BT8009 Alone or with Pembrolizumab for Patients with Advanced or Metastatic Bladder Cancer
- Study of Atezolizumab Treatment Before Surgery in Patients with Bladder Cancer or Upper Urinary Tract Cancer
Study for Patients with Lung or Urinary Tract Cancer Continuing Treatment with Durvalumab, Infliximab, and Mycophenolate Mofetil
This trial is designed for patients who have previously participated in cancer studies and continue to benefit from treatment with durvalumab. The study focuses on patients with post-chemotherapy urothelial and non-urothelial carcinoma of the urinary tract, among other cancer types.
Who can participate: To join this study, patients must be currently benefiting from durvalumab treatment in a previous trial and must provide written informed consent. They should be eligible to receive durvalumab at a fixed dose of 1500 mg every four weeks. The study accepts both male and female patients, including those who may be considered part of vulnerable populations.
Who cannot participate: Patients with cancer types not covered by the study cannot participate. Those who have not completed previous required treatments, have medical conditions that could interfere with the study treatment, or are unable to follow study procedures are excluded. Pregnant or breastfeeding women, patients with severe allergies to the study medication, those with serious infections or illnesses, patients currently in another clinical trial, and those with a history of substance abuse or recent major surgery are also excluded.
Study focus: The main goal is to continue providing durvalumab treatment to patients who are still benefiting from it and to monitor the safety and tolerability of the treatment. The study will track any serious side effects occurring up to 90 days after the last dose.
Treatment: The investigational drug is durvalumab, an immunotherapy medication that helps the body’s immune system fight cancer by blocking a protein that prevents immune cells from attacking cancer cells. It is administered as an intravenous infusion. Additional medications that may be used include infliximab (given through infusion) and mycophenolate mofetil (taken orally in capsule form).
Study of BT8009 Alone or with Pembrolizumab for Patients with Advanced or Metastatic Bladder Cancer
This trial investigates treatment options for urothelial cancer affecting the bladder and urinary system. The study explores the effectiveness of BT8009, an experimental medication, both alone and combined with other treatments including pembrolizumab and chemotherapy drugs.
Who can participate: Patients must be at least 18 years old and able to understand and consent to the study. They must have a confirmed diagnosis of locally advanced or metastatic urothelial cancer with measurable disease. Participants need available tumor tissue for testing and a life expectancy of at least 12 weeks. Adequate organ function is required, including normal levels of liver enzymes, kidney function, and blood clotting times. Women who can have children must have a negative pregnancy test and agree to use effective birth control, as must men with partners who can become pregnant.
Who cannot participate: Patients with different cancer types than those being studied, those outside the specified age range, or those unable to follow study procedures are excluded. Others excluded include patients with serious health conditions that might interfere with treatment, pregnant or breastfeeding women, those who recently received other cancer treatments, patients with allergies to study drugs, and those participating in another clinical trial simultaneously.
Study focus: The trial aims to evaluate progression-free survival and overall response rate when using BT8009 either as a standalone treatment or combined with pembrolizumab, compared to standard chemotherapy approaches. Researchers will monitor how well these treatments slow cancer progression or reduce tumor size.
Treatment: The investigational drugs include BT8009 (an antibody-drug conjugate targeting specific proteins on cancer cells), pembrolizumab (an immunotherapy medication), cisplatin and carboplatin (chemotherapy drugs that damage cancer cell DNA), gemcitabine (a chemotherapy drug that blocks cancer cell growth), and avelumab (an immunotherapy used as maintenance treatment). All are administered through intravenous infusion.
Study of BT8009 Alone or with Pembrolizumab for Patients with Advanced or Metastatic Bladder Cancer
This Spanish trial studies treatments for urothelial cancer affecting the bladder and urinary system, testing the investigational medication BT8009 both independently and combined with other therapies.
Who can participate: Patients must be at least 18 years old, able to understand and consent to the study, and willing to follow study procedures. They need a confirmed diagnosis of locally advanced or metastatic urothelial cancer with measurable disease and available tumor tissue for testing. A life expectancy of at least 12 weeks is required. Adequate organ function is necessary, including normal bilirubin levels (unless the patient has Gilbert disease), sufficient albumin and liver enzyme levels, good kidney function, and normal blood clotting times. Women who can become pregnant must have a negative pregnancy test and agree to birth control measures, as must men with partners of childbearing potential.
Who cannot participate: Excluded are patients with different cancer types, those outside the specified age range, patients unable to attend required visits, those with serious interfering health conditions, pregnant or breastfeeding women, patients who recently received other cancer treatments, those with allergies to study medications, and patients participating in another trial.
Study focus: The study evaluates how effectively BT8009 treats urothelial cancer, monitoring cancer response and progression over several months with regular check-ups. It aims to determine the best treatment options by comparing BT8009 alone and in combination with other therapies.
Treatment: The investigational drugs include BT8009 (targeting specific cancer cell proteins), pembrolizumab (helping the immune system fight cancer), cisplatin and carboplatin (chemotherapy drugs killing cancer cells), gemcitabine (stopping cancer cell growth), and avelumab (maintenance immunotherapy). All medications are administered through intravenous infusion.
Study of Atezolizumab Treatment Before Surgery in Patients with Bladder Cancer or Upper Urinary Tract Cancer
This study examines the effectiveness of atezolizumab given before surgery to patients with bladder and upper urinary tract urothelial cancer who either cannot receive or choose not to receive standard cisplatin chemotherapy.
Who can participate: Patients must be 18 years or older, able to provide written consent, and willing to follow study procedures. They must have remaining cancer tissue after initial surgery and be planning to undergo bladder or upper urinary tract removal surgery. The cancer must not have spread beyond nearby lymph nodes. Patients must have tissue samples available for testing and either decline or be unsuitable for cisplatin chemotherapy. Good physical function status is required (able to perform daily activities). Women who can become pregnant need a negative pregnancy test and must use reliable birth control during the study and for five months afterward. Adequate blood test results are necessary, showing sufficient blood cells, acceptable liver and kidney function, and normal blood clotting.
Who cannot participate: Excluded are patients with a history of autoimmune disease, previous immunotherapy treatment, active or untreated brain metastases, significant heart conditions, active infections (including hepatitis B, C, or HIV), other cancers within the last five years (except successfully treated non-melanoma skin cancer or cervical cancer), pregnant or breastfeeding women, severe kidney or liver problems, known allergies to study medications, major surgery within four weeks before treatment, recent participation in other trials, or any condition making participation unsafe.
Study focus: The main purpose is to determine if atezolizumab can reduce cancer size before surgery and to study how the medication affects the immune system. The study monitors treatment tolerance and tracks patient progress after surgery through regular medical examinations and imaging tests.
Treatment: The investigational drug is atezolizumab (brand name Tecentriq), a monoclonal antibody and immune checkpoint inhibitor administered through intravenous infusion at 1,200 mg. It works by blocking the PD-L1 protein, helping the immune system better detect and fight cancer cells. The treatment period lasts up to six months before surgery.
Summary
The four ongoing clinical trials for malignant urinary tract neoplasm demonstrate a strong focus on immunotherapy approaches, particularly in patients with advanced or metastatic urothelial cancer. All studies investigate immune checkpoint inhibitors as either standalone treatments or in combination with chemotherapy or other immunotherapies.
The trials are concentrated primarily in Western and Central European countries, with Spain participating in all four studies, and countries like Germany, France, Poland, Bulgaria, Romania, and Italy hosting multiple trials. One trial extends across 18 European countries, indicating broad international collaboration in researching these treatments.
A notable pattern is the emphasis on providing treatment options for patients who cannot receive or choose not to undergo standard cisplatin-based chemotherapy. Several trials specifically target this patient population, offering alternative treatment pathways through immunotherapy medications such as durvalumab, pembrolizumab, atezolizumab, and the investigational drug BT8009.
The studies employ different treatment strategies: continuation therapy for patients already benefiting from previous treatments, neoadjuvant therapy given before surgery to shrink tumors, and various combination approaches comparing new medications against standard chemotherapy regimens. This diverse range of approaches reflects ongoing efforts to find more effective and better-tolerated treatments for patients with urinary tract cancers at different disease stages.