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PhAse 1/2 StuDy of Modern ImmunotherApy in BCG-RelaPsing UroThelial Carcinoma of the BLADDER – (ADAPT-BLADDER) HCRN GU16-243 (PSCI 18-129)

This is a Phase II drug study which is designed to examine the effects of Durvalumab on individuals with bladder cancer that has not invaded muscle tissue. Study subjects will have already been treated with one or more surgical resections and Bacillus Calmette-Guerin or BCG, and the disease has now recurred.
Kathleen Rizzo at krizzo@pennstatehealth.psu.edu
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03317158
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Inclusion Criteria:
Histologically confirmed non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage) on transurethral resection of bladder tumor (TURBT) obtained within 60 days of registration.
ECOG (WHO) performance status 0 or 1
Age ≥ 18 years old at time of consent
White blood cell count (WBC) > 3.0 K/mm3
Absolute neutrophil count (ANC) ≥ 1.5 K/mm3
Exclusion Criteria:
Subjects with muscle-invasive (i.e. T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on baseline radiographic imaging obtained within 60 days prior to study registration.
Subjects with 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.
Subjects who 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.
Subjects who have had any prior radiation to the prostate or pelvis.
Cancer
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Location
Hershey, PA