Clinical Trial for Patients with Muscle Invasive Bladder Cancer (MIBC) who have Progressed on Prior Treatment (Astra Zeneca GU118)
Technical Title: An Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Multi-Centre, Multi-arm Phase 1b Study in patients with Muscle Invasive Bladder Cancer (MIBC) who have progressed on prior treatment (BISCAY) D2615C00001
Disease Type: Metastatic muscle invasive bladder cancer (MIBC) (urothelial) that has not responded to another treatment, or that has returned after being treated with another medicine.
This research is testing two new study drugs (MEDI4736 and AZD4547) to find out if they can treat metastatic MIBC effectively. The study will also look for side effects caused by the study drugs and examine how long the drugs remain in blood.
To participate in this study, you will need to provide a sample of your tumor tissue to determine what genetic type of bladder cancer you have. You will only be offered treatment on this study if your tumor sample shows certain types of genetic mutations. The treatment you receive will match the genetics of your tumor sample. This means that different patients are offered different treatments on this study. This study will test the theory that these matched treatments may give a better treatment response.
The treatments that are offered in this study and the genetic mutations they are matched to are as follows:
Patients who do not have a specific mutation for the study will receive AZD9150 in combination with MEDI4736 (durvalumab). AZD9150 is given by an intravenous injection once every two days for a week, for a total of 3 doses. It is then given once a week. MEDI4736 is an intravenous injection given once a month.
Research Procedures (not a complete list):
The research procedures you complete will depend on what treatment you receive. Generally, you will need to visit the clinic at least once a week in the first month of the study and once a month thereafter for follow up. Depending on the visit, you may need to complete a physical exam, blood and urine tests, and heart tests. You will also complete scans (like MRI and CT scans) once every 8 weeks. A fresh research biopsy will also be required during the second month.
Eligibility Criteria (Not a complete list):
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