Finding studies
Finding studies
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Lead
SWOG Cancer Research Network
With
PRIMARY OBJECTIVE: I. To compare pathologic complete response (pCR, pT0N0) with avelumab plus gemcitabine and carboplatin (AGCa) versus (vs.) no neoadjuvant therapy preceding protocol surgery for muscle-invasive bladder cancer or upper tract urothelial carcinoma (MIBC/UTUC) for participants who are ineligible for cisplatin-based chemotherapy. SECONDARY OBJECTIVES: I. To evaluate toxicities with AGCa, and to compare resectability rates and surgical complications by arm in this population. II. To compare event-free survival (EFS) with AGCa versus no neoadjuvant therapy in this population. III. To compare overall survival (OS) with AGCa versus no neoadjuvant therapy preceding surgery in this population. IV. To compare pathologic complete response (pCR, pT0N0) with avelumab plus gemcitabine and carboplatin (AGCa) vs. no neoadjuvant therapy preceding protocol surgery in the subset of participants who received at least 2 cycles of neoadjuvant therapy in Arm A. BANKING OBJECTIVE: I. To bank tumor tissue, blood, and urine for future correlative genomic, transcriptomic, and proteomic studies to discover molecular signatures associated with pCR and resistance. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive avelumab intravenously (IV) over 60 minutes on day 1. Treatment repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up 4 in the absence of disease progression or unacceptable toxicity. Within 4-8 weeks after final systemic therapy, patients undergo standard of care surgery. ARM B: Patients undergo standard of care surgery. After completion of study treatment, patients are followed up every 12 weeks for years 1-2, every 6 months for year 3, then annually in years 4-5.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
