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1 Study Matches

Site for A study of enfortumab vedotin (ASG-22CE) as monotherapy or in combination with other anticancer therapies for the treatment of urothelial cancer

This study is to determine the recommended Phase 3 dose of venetoclax in combination with azacitidine in AML patients when given as maintenance therapy following allogeneic stem cell transplantation. It also is to determine if venetoclax can be effective in combination with azacitidine to improve RFS in AML patients compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation.
Kathleen Rizzo at or 717-531-8678
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Patients must have histologically documented locally advanced or metastatic urothelial (previously known as transitional cell) cancer (i.e., cancer of the bladder, renal pelvis, ureter, or urethra).
Patients in dose-escalation cohorts, Cohort A, Optional Cohort B, Cohort G, and Cohort K must be eligible for CPI therapy.
Minimum age of 18 years
Patients must have measurable disease according to RECIST Version 1.1
An ECOG performance status of 0, 1, or 2
Exclusion Criteria:
Received any prior treatment with a CPI. A CPI is defined as a PD-1 inhibitor, PD-L1 inhibitor, or PD-L2 inhibitor (including, but not limited to, atezolizumab, pembrolizumab, nivolumab, durvalumab, or avelumab).
Ongoing sensory or motor neuropathy Grade 2 or higher.
Active central nervous system (CNS) metastases.
Ongoing clinically significant toxicity (Grade 2 or greater) associated with prior treatment (including radiotherapy or surgery).
Patients with conditions requiring high doses of steroids (>10 mg/day of prednisone or equivalent) or other immunosuppressive medications are excluded.
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Hershey, PA