Last updated 18 days ago
Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin
677 patients around the world
Available in Argentina, Chile, Mexico, United States, Brazil, Spain
Not provided
AstraZeneca
11Research sites
677Patients around the world
This study is for people with
Bladder Cancer
High Risk Muscle Invasive Bladder Cancer
Requirements for the patient
To 130 Years
All Gender
Medical requirements
- Histologically or cytologically documented muscle-invasive UC of the bladder.Participants with transitional cell and mixed transitional/non-transitional cell histologies;Participants with MIBC clinical tumor (T) stage T2-T4aN0/1M0 or UC of the bladder with clinical state T1N1M0.Participants should also have not received prior systemic chemotherapy or immunotherapy for the treatment of MIBC or bladder UC.Medically fit for cystectomy and able to receive neoadjuvant therapy;Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC;ECOG performance status of 0,1,2 at enrollment.Availability of tumor sample prior to study entry;Must have a life expectancy of at least 12 weeks at randomization.Cisplatin-ineligible, as defined by any of the following criteria (based on Galsky et al 2011) OR Refuse cisplatin based chemotherapy (must be documented in the medical records)
- Evidence of lymph node (N2+) or metastatic TCC/UC disease at the time of screening.Active infectionUncontrolled intercurrent illnessPrior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti--PD-1, anti PD-L1, or anti-PD-L2 antibodies.Current or prior use of immunosuppressive medication within 14 days before the first dose of IPs.
Sites
Hospital Británico de Buenos Aires - CABA
Recruiting
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Centro de Investigación Pergamino SA
Recruiting
Hospital Universitario Austral - Pilar
Recruiting
Instituto de Oncología de Rosario - IOR
Instituto Universitario CEMIC - CABA
Recruiting
Centro de Oncología e Investigación Buenos Aires COIBA
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
CDU - Centro de Urología - Buenos Aires
Hemato Oncólogos S.A.
Recruiting
StudyVOLGA
SponsorAstraZeneca
Study typeInterventional
Conditions
High Risk Muscle Invasive Bladder CancerBladder Cancer
Requirements
To 130 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04960709
