Avelumab and Radiation in Muscle-Invasive Bladder Cancer (NCT03747419) | Clinical Trial Compass
TerminatedPhase 2
Avelumab and Radiation in Muscle-Invasive Bladder Cancer
Stopped: In agreement with the drug sponsor and the institution, the trial has been terminated due to slow accrual.
United States14 participantsStarted 2018-12-13
Plain-language summary
This research study is studying the effects of adding a certain type of immunotherapy to standard bladder-directed radiation as a treatment for muscle-invasive urothelial carcinoma of the bladder.
The drug in this study is: Avelumab (also known as BAVENCIO®)
Who can participate
Age range18 Years
SexALL
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Subjects must meet all of the following applicable inclusion criteria to participate in the study.
Inclusion Criteria:
* Histologically confirmed transitional cell (urothelial) carcinoma of the bladder that is invasive into the muscularis propria (≥T2 disease) within 6 months of enrollment date. The presence of variant histologies (squamous, adenocarcinoma, micropapillary, etc.) is allowed. Note: A prior diagnosis of non-muscle-invasive bladder cancer (≤T1) managed with transurethral resection with or without intravesicular therapy (now with muscle invasion) is allowed.
* Inability to receive cisplatin-based chemotherapy, as defined by creatinine clearance \<60 ml/min, ECOG PS ≤2, grade 2 or higher hearing loss, NYHA class 3 or higher, neuropathy (grade 2 or higher), or patient refusal to receive cisplatin-based chemotherapy.
Additional Inclusion Criteria:
* Male or female subjects aged ≥18 years
* ECOG performance status ≤2 or Karnofsky score ≥60% (see Appendix A)
* Life expectancy of greater than 1 year
* Demonstrate normal organ and marrow function
* Estimated creatinine clearance \> 30 mL/min according to the Cockcroft-Gault formula.
* Women of child-bearing age must have a negative serum pregnancy test at screening.
* Women of child-bearing potential and men must agree to use a highly effective method of contraception (hormonal or barrier method of birth control, or abstinence) beginning prior to study entry, for the duration of study participation, and for at least …
What they're measuring
1
Complete Clinical Response Rate
Timeframe: 3 months following completion of radiation; then every 3 months until 2 years after registration; then every 6 months up to a maximum of 3 years after registration