Clinical Trial TitlePhase 1/2 study of modern immunotherapy in BCG-relapsing urothelial carcinoma of the bladder – (ADAPT-BLADDER) HCRN GU16-243.
National Clinical Trial Number:NCT03317158
Clinical Trial Protocol Description:
This study assesses the safety and recommended dose of durvalumab when added to BCG treatment and will also evaluate if durvalumab when added to BCG treatment or radiation treatment will decrease the risk cancer coming back.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have histologically confirmed non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage) on TURBT obtained within 42 days of registration.
- Have an ECOG (WHO) performance status of 0 or 1.
- Have BCG-unresponsive disease defined by any of the following:
- Persistent or recurrent CIS with or without the presence of concurrent Ta or T1 tumors within 12 months of completion of adequate BCG therapy.
- Recurrent high-grade Ta or T1 tumors within 6 months of completion of adequate BCG therapy.
You will be excluded from the study if any of the following criteria apply to you:
- Have muscle-invasive (i.e. T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on baseline radiographic imaging obtained within 28 days prior to study registration. The required radiographic imaging includes:
- Abdomen/Pelvis - CT scan
- Chest - chest x-ray or CT scan
- Have another active second malignancy other than non-melanoma skin cancers and biochemical relapsed prostate cancer. Subjects that have completed all necessary therapy and are considered to be at less than 30% risk of relapse are not considered to have an active second malignancy and are eligible for enrollment.
- Have received the last administration of an anti-cancer therapy including chemotherapy, immunotherapy, and monoclonal antibodies ≤ 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy.
- Have had any prior radiation to the prostate or pelvis.
This is a partial list of elgibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.