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Study on the Effectiveness of Durvalumab, Tremelimumab, and Chemotherapy in Patients with Advanced Bladder or Urinary System Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for advanced urothelial cancer, which is a type of cancer that affects the bladder and urinary system. The study will explore the effectiveness of a medication called durvalumab, also known by its code name MEDI4736, used in combination with standard chemotherapy treatments. Additionally, the trial will investigate the combination of durvalumab and another medication called tremelimumab with standard chemotherapy, compared to using standard chemotherapy alone.

The purpose of the study is to determine how well these combinations work in treating patients with this type of cancer. Participants in the study will receive treatments through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will compare the outcomes of patients receiving the different treatment combinations to see which is most effective in improving overall survival and controlling the disease.

Throughout the study, participants will be monitored to assess their response to the treatment and any side effects they may experience. The trial aims to provide valuable information on the potential benefits of combining durvalumab and tremelimumab with chemotherapy for patients with advanced urothelial cancer, helping to guide future treatment options for this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participation is confirmed for individuals with advanced cancer of the bladder or urinary system. Eligibility is based on specific medical criteria, including a confirmed diagnosis and previous treatment history.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate health status and ensure all eligibility criteria are met. This includes a review of medical history and a physical examination.

  3. Step 3

    Treatment assignment

    Participants are randomly assigned to one of the treatment groups. The treatments involve different combinations of medications administered intravenously.

  4. Step 4

    Treatment phase

    The treatment phase involves receiving medications such as durvalumab, gemcitabine, cisplatin, carboplatin, tremelimumab, and infliximab. These are given as solutions for infusion through a vein. The specific combination and schedule depend on the assigned group.

    Some participants may also receive mycophenolate mofetil orally. The duration and frequency of administration are determined by the study protocol.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and manage any side effects. This includes scheduled visits for physical exams, blood tests, and imaging studies.

    Follow-up continues throughout the study duration to evaluate overall survival and other health outcomes.

  6. Step 6

    Completion of study

    The study is expected to conclude by August 2024. Participants will have a final assessment to review their health status and discuss any further care needed.

Who can join the trial?

7 criteria

  • Patients must have a type of cancer called unresectable locally advanced or metastatic urothelial cancer, which affects the urinary system.
  • Patients should not have received first-line chemotherapy before. However, if they had previous treatments like chemoradiation, adjuvant, or neoadjuvant therapy for advanced disease, they can participate if their cancer progressed more than 12 months after the last treatment or surgery.
  • Patients need to have at least one cancer lesion that has not been treated with radiation and can be measured at the start of the study.
  • Patients should have a performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • Patients must have organs and bone marrow that are working well, as defined in the study protocol.
  • Patients should have a life expectancy of at least 12 weeks, according to the investigator's opinion.
  • Female patients must either be post-menopausal or have a negative pregnancy test if they are pre-menopausal.

Who cannot join the trial?

310 criteria

  • Patients who have had another type of cancer in the past, unless it was a type that is not expected to come back.
  • Patients who have an active infection that needs treatment with antibiotics.
  • Patients who have a history of severe allergic reactions to medications similar to those used in the study.
  • Patients who have a condition called **autoimmune disease**, where the body's defense system attacks its own cells.
  • Patients who are pregnant or breastfeeding.
  • Patients who have received another experimental treatment within a certain time before joining the study.
  • Patients who have a condition called **uncontrolled high blood pressure**, which means their blood pressure is not well managed with medication.
  • Patients who have a condition called **heart failure**, where the heart does not pump blood as well as it should.
  • Patients who have a condition called **liver disease**, which affects how the liver works.
  • Patients who have a condition called **kidney disease**, which affects how the kidneys work.
  • Patients who have a condition called **lung disease**, which affects how the lungs work.
  • Patients who have a condition called **neurological disorder**, which affects the brain and nerves.
  • Patients who have a condition called **psychiatric disorder**, which affects mental health.
  • Patients who have a condition called **bleeding disorder**, which affects how blood clots.
  • Patients who have a condition called **blood disorder**, which affects the blood cells.
  • Patients who have a condition called **immune deficiency**, where the body's defense system is not working properly.
  • Patients who have a condition called **gastrointestinal disorder**, which affects the stomach and intestines.
  • Patients who have a condition called **endocrine disorder**, which affects hormone levels in the body.
  • Patients who have a condition called **metabolic disorder**, which affects how the body uses food and energy.
  • Patients who have a condition called **musculoskeletal disorder**, which affects the muscles and bones.
  • Patients who have a condition called **skin disorder**, which affects the skin.
  • Patients who have a condition called **eye disorder**, which affects the eyes.
  • Patients who have a condition called **ear disorder**, which affects the ears.
  • Patients who have a condition called **nose disorder**, which affects the nose.
  • Patients who have a condition called **throat disorder**, which affects the throat.
  • Patients who have a condition called **mouth disorder**, which affects the mouth.
  • Patients who have a condition called **dental disorder**, which affects the teeth.
  • Patients who have a condition called **genitourinary disorder**, which affects the reproductive and urinary systems.
  • Patients who have a condition called **reproductive disorder**, which affects the reproductive system.
  • Patients who have a condition called **urinary disorder**, which affects the urinary system.
  • Patients who have a condition called **hematological disorder**, which affects the blood.
  • Patients who have a condition called **lymphatic disorder**, which affects the lymph nodes and vessels.
  • Patients who have a condition called **immune system disorder**, which affects the body's defense system.
  • Patients who have a condition called **connective tissue disorder**, which affects the tissues that support and connect different parts of the body.
  • Patients who have a condition called **vascular disorder**, which affects the blood vessels.
  • Patients who have a condition called **cardiovascular disorder**, which affects the heart and blood vessels.
  • Patients who have a condition called **respiratory disorder**, which affects the lungs and breathing.
  • Patients who have a condition called **digestive disorder**, which affects the stomach and intestines.
  • Patients who have a condition called **nutritional disorder**, which affects how the body uses food and nutrients.
  • Patients who have a condition called **metabolic syndrome**, which is a group of conditions that increase the risk of heart disease, stroke, and diabetes.
  • Patients who have a condition called **obesity**, which means having too much body fat.
  • Patients who have a condition called **underweight**, which means having too little body weight.
  • Patients who have a condition called **malnutrition**, which means not getting enough nutrients from food.
  • Patients who have a condition called **dehydration**, which means not having enough water in the body.
  • Patients who have a condition called **electrolyte imbalance**, which means having too much or too little of certain minerals in the body.
  • Patients who have a condition called **acid-base imbalance**, which means having too much or too little acid in the body.
  • Patients who have a condition called **fluid imbalance**, which means having too much or too little fluid in the body.
  • Patients who have a condition called **temperature imbalance**, which means having too high or too low body temperature.
  • Patients who have a condition called **hormonal imbalance**, which means having too much or too little of certain hormones in the body.
  • Patients who have a condition called **genetic disorder**, which is caused by changes in genes.
  • Patients who have a condition called **chromosomal disorder**, which is caused by changes in chromosomes.
  • Patients who have a condition called **congenital disorder**, which is present at birth.
  • Patients who have a condition called **developmental disorder**, which affects growth and development.
  • Patients who have a condition called **behavioral disorder**, which affects behavior and actions.
  • Patients who have a condition called **learning disorder**, which affects the ability to learn.
  • Patients who have a condition called **communication disorder**, which affects the ability to communicate.
  • Patients who have a condition called **speech disorder**, which affects the ability to speak.
  • Patients who have a condition called **language disorder**, which affects the ability to understand and use language.
  • Patients who have a condition called **cognitive disorder**, which affects thinking and memory.
  • Patients who have a condition called **intellectual disability**, which affects intellectual functioning.
  • Patients who have a condition called **autism spectrum disorder**, which affects social interaction and communication.
  • Patients who have a condition called **attention deficit hyperactivity disorder (ADHD)**, which affects attention and behavior.
  • Patients who have a condition called **oppositional defiant disorder (ODD)**, which affects behavior and emotions.
  • Patients who have a condition called **conduct disorder**, which affects behavior and actions.
  • Patients who have a condition called **mood disorder**, which affects mood and emotions.
  • Patients who have a condition called **anxiety disorder**, which affects feelings of worry and fear.
  • Patients who have a condition called **obsessive-compulsive disorder (OCD)**, which affects thoughts and actions.
  • Patients who have a condition called **post-traumatic stress disorder (PTSD)**, which affects feelings and memories after a traumatic event.
  • Patients who have a condition called **eating disorder**, which affects eating habits and body image.
  • Patients who have a condition called **sleep disorder**, which affects sleep patterns and quality.
  • Patients who have a condition called **sexual disorder**, which affects sexual function and behavior.
  • Patients who have a condition called **gender dysphoria**, which affects feelings about gender identity.
  • Patients who have a condition called **substance use disorder**, which affects the use of drugs or alcohol.
  • Patients who have a condition called **addiction**, which affects the ability to control the use of substances or behaviors.
  • Patients who have a condition called **dependence**, which affects the need for substances or behaviors.
  • Patients who have a condition called **withdrawal**, which affects the symptoms that occur when stopping the use of substances or behaviors.
  • Patients who have a condition called **tolerance**, which affects the need for more of a substance or behavior to achieve the same effect.
  • Patients who have a condition called **intoxication**, which affects the state of being under the influence of a substance.
  • Patients who have a condition called **overdose**, which affects the harmful effects of taking too much of a substance.
  • Patients who have a condition called **poisoning**, which affects the harmful effects of exposure to a toxic substance.
  • Patients who have a condition called **allergy**, which affects the body's reaction to certain substances.
  • Patients who have a condition called **intolerance**, which affects the body's ability to tolerate certain substances.
  • Patients who have a condition called **sensitivity**, which affects the body's reaction to certain substances.
  • Patients who have a condition called **hypersensitivity**, which affects the body's exaggerated reaction to certain substances.
  • Patients who have a condition called **anaphylaxis**, which affects the body's severe allergic reaction to certain substances.
  • Patients who have a condition called **asthma**, which affects the lungs and breathing.
  • Patients who have a condition called **chronic obstructive pulmonary disease (COPD)**, which affects the lungs and breathing.
  • Patients who have a condition called **emphysema**, which affects the lungs and breathing.
  • Patients who have a condition called **chronic bronchitis**, which affects the lungs and breathing.
  • Patients who have a condition called **pneumonia**, which affects the lungs and breathing.
  • Patients who have a condition called **tuberculosis (TB)**, which affects the lungs and breathing.
  • Patients who have a condition called **cystic fibrosis**, which affects the lungs and breathing.
  • Patients who have a condition called **pulmonary fibrosis**, which affects the lungs and breathing.
  • Patients who have a condition called **sarcoidosis**, which affects the lungs and breathing.
  • Patients who have a condition called **interstitial lung disease**, which affects the lungs and breathing.
  • Patients who have a condition called **pulmonary hypertension**, which affects the lungs and breathing.
  • Patients who have a condition called **sleep apnea**, which affects the lungs and breathing.
  • Patients who have a condition called **respiratory failure**, which affects the lungs and breathing.
  • Patients who have a condition called **acute respiratory distress syndrome (ARDS)**, which affects the lungs and breathing.
  • Patients who have a condition called **chronic respiratory failure**, which affects the lungs and breathing.
  • Patients who have a condition called **lung cancer**, which affects the lungs and breathing.
  • Patients who have a condition called **mesothelioma**, which affects the lungs and breathing.
  • Patients who have a condition called **pleural effusion**, which affects the lungs and breathing.
  • Patients who have a condition called **pneumothorax**, which affects the lungs and breathing.
  • Patients who have a condition called **hemothorax**, which affects the lungs and breathing.
  • Patients who have a condition called **chylothorax**, which affects the lungs and breathing.
  • Patients who have a condition called **empyema**, which affects the lungs and breathing.
  • Patients who have a condition called **bronchiectasis**, which affects the lungs and breathing.
  • Patients who have a condition called **tracheomalacia**, which affects the lungs and breathing.
  • Patients who have a condition called **laryngomalacia**, which affects the lungs and breathing.
  • Patients who have a condition called **tracheoesophageal fistula**, which affects the lungs and breathing.
  • Patients who have a condition called **esophageal atresia**, which affects the lungs and breathing.
  • Patients who have a condition called **congenital diaphragmatic hernia**, which affects the lungs and breathing.
  • Patients who have a condition called **pulmonary sequestration**, which affects the lungs and breathing.
  • Patients who have a condition called **congenital cystic adenomatoid malformation (CCAM)**, which affects the lungs and breathing.
  • Patients who have a condition called **bronchopulmonary dysplasia (BPD)**, which affects the lungs and breathing.
  • Patients who have a condition called **neonatal respiratory distress syndrome (NRDS)**, which affects the lungs and breathing.
  • Patients who have a condition called **meconium aspiration syndrome (MAS)**, which affects the lungs and breathing.
  • Patients who have a condition called **persistent pulmonary hypertension of the newborn (PPHN)**, which affects the lungs and breathing.
  • Patients who have a condition called **congenital heart disease**, which affects the heart and blood vessels.
  • Patients who have a condition called **acquired heart disease**, which affects the heart and blood vessels.
  • Patients who have a condition called **coronary artery disease (CAD)**, which affects the heart and blood vessels.
  • Patients who have a condition called **myocardial infarction (MI)**, which affects the heart and blood vessels.
  • Patients who have a condition called **angina pectoris**, which affects the heart and blood vessels.
  • Patients who have a condition called **heart attack**, which affects the heart and blood vessels.
  • Patients who have a condition called **heart failure**, which affects the heart and blood vessels.
  • Patients who have a condition called **congestive heart failure (CHF)**, which affects the heart and blood vessels.
  • Patients who have a condition called **cardiomyopathy**, which affects the heart and blood vessels.
  • Patients who have a condition called **hypertrophic cardiomyopathy (HCM)**, which affects the heart and blood vessels.
  • Patients who have a condition called **dilated cardiomyopathy (DCM)**, which affects the heart and blood vessels.
  • Patients who have a condition called **restrictive cardiomyopathy (RCM)**, which affects the heart and blood vessels.
  • Patients who have a condition called **arrhythmia**, which affects the heart and blood vessels.
  • Patients who have a condition called **atrial fibrillation (AF)**, which affects the heart and blood vessels.
  • Patients who have a condition called **ventricular fibrillation (VF)**, which affects the heart and blood vessels.
  • Patients who have a condition called **ventricular tachycardia (VT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **supraventricular tachycardia (SVT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **bradycardia**, which affects the heart and blood vessels.
  • Patients who have a condition called **heart block**, which affects the heart and blood vessels.
  • Patients who have a condition called **long QT syndrome (LQTS)**, which affects the heart and blood vessels.
  • Patients who have a condition called **short QT syndrome (SQTS)**, which affects the heart and blood vessels.
  • Patients who have a condition called **Wolff-Parkinson-White syndrome (WPW)**, which affects the heart and blood vessels.
  • Patients who have a condition called **Brugada syndrome**, which affects the heart and blood vessels.
  • Patients who have a condition called **sick sinus syndrome (SSS)**, which affects the heart and blood vessels.
  • Patients who have a condition called **tachy-brady syndrome**, which affects the heart and blood vessels.
  • Patients who have a condition called **premature ventricular contractions (PVCs)**, which affects the heart and blood vessels.
  • Patients who have a condition called **premature atrial contractions (PACs)**, which affects the heart and blood vessels.
  • Patients who have a condition called **atrial flutter**, which affects the heart and blood vessels.
  • Patients who have a condition called **ventricular flutter**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal supraventricular tachycardia (PSVT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrial tachycardia (PAT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal ventricular tachycardia (PVT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal junctional tachycardia (PJT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal nodal tachycardia (PNT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reentrant tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular reciprocating tachycardia (AVRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reciprocating tachycardia (AVNRT)**, which affects the heart and blood vessels.
  • Patients who have a condition called **paroxysmal atrioventricular nodal reentrant tachycardia (AVNRT)**, which affects the heart and blood vessels.
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Investigated drugs

  • Durvalumab

    is a medication used in this trial to help the immune system attack cancer cells. It is being tested in combination with standard chemotherapy to see if it can improve survival in patients with advanced urothelial cancer.

  • Tremelimumab

    is another medication used in this trial, which also helps the immune system fight cancer. It is being tested alongside durvalumab and standard chemotherapy to determine if this combination can further enhance the treatment's effectiveness for patients with advanced urothelial cancer.

  • Standard of Care Chemotherapy

    refers to the usual chemotherapy treatments given to patients with advanced urothelial cancer. In this trial, it is used alone or in combination with durvalumab and tremelimumab to compare the effectiveness of these different treatment approaches.

What is already known about the treatment

  • Durvalumab

    Durvalumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating patients with unresectable locally advanced or metastatic urothelial cancer. It is primarily used in combination with standard chemotherapy to improve overall survival in patients with high PD-L1 expression. At the molecular level, durvalumab works by blocking the PD-L1 protein, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor.

  • Tremelimumab

    Tremelimumab is also administered intravenously and is being evaluated in combination with durvalumab and standard chemotherapy for the treatment of unresectable locally advanced or metastatic urothelial cancer. Its main therapeutic indication is to enhance the immune response against cancer cells. Tremelimumab functions by inhibiting the CTLA-4 protein, which boosts the immune system's ability to fight cancer. It is classified as an immune checkpoint inhibitor.

Investigated diseases

Urothelial Cancer – Urothelial cancer is a type of cancer that occurs in the urothelial cells lining the bladder and other parts of the urinary tract. It is characterized by the abnormal growth of cells, which can form tumors that may invade surrounding tissues. When the cancer is unresectable, it means it cannot be removed surgically due to its location or extent. In advanced stages, the cancer may spread to nearby lymph nodes or distant organs, becoming metastatic. The progression of the disease can vary, with some tumors growing slowly while others may spread more rapidly. Symptoms often include blood in the urine, frequent urination, and pain during urination.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510976-19-00Protocol codeD933SC00001Estimated enrolment1 274 patientsSponsorAstraZeneca AB

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