Clinical trial locations
- Austria
- Belgium
- Bulgaria
- Czechia
- Denmark
- France
- 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
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 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.