Fox Chase Cancer Center
RETAIN-3 is a phase II study in patients with cT2-T3N0M0 muscle-invasive urothelial carcinoma of the bladder. Participants will receive neoadjuvant enfortumab vedotin and pembrolizumab followed by clinical and biomarker-based assessment to inform subsequent treatment management.
RETAIN-3 is a multicenter, open-label, phase II study evaluating a biomarker- and response-adapted bladder preservation strategy in patients with cT2-T3N0M0 muscle-invasive bladder cancer treated with neoadjuvant enfortumab vedotin and pembrolizumab. Following treatment, participants undergo clinical restaging and biomarker assessment to guide subsequent management, which may include active surveillance, maintenance therapy, cystectomy, or chemoradiation. The study aims to determine whether a biomarker-guided approach can preserve the bladder in selected patients while maintaining favorable on…
Inclusion Criteria: * Primary urothelial or predominantly urothelial carcinoma of the bladder confirmed from pathology report. Patients with some component of variant histology mixed with predominant urothelial carcinoma will be allowed. Upper tract urothelial carcinoma patients are not allowed. * Urothelial carcinoma of the prostatic urethra in men is allowed * Histologic evidence of muscularis propria invasion. * AJCC(22) clinical stage T2-T3 N0M0. * No radiographic evidence of lymph node positive disease as per RECIST 1.1 (≥15 mm short axis diameter). If a lymph node is greater than 1.5 cm…
1.25 mg/kg (maximum 125 mg) intravenously on Days 1 and 8 of each 21-day cycle for 3 cycles.
200 mg intravenously on Day 1 of each 21-day cycle or subcutaneous pembrolizumab/berahyaluronidase formulation administered per protocol.
Cisplatin administered as a radiosensitizing chemotherapy regimen in participants receiving chemoradiation.
Gemcitabine administered as a radiosensitizing chemotherapy regimen in participants receiving chemoradiation.
Fluorouracil administered as a radiosensitizing chemotherapy regimen in participants receiving chemoradiation.
Mitomycin C administered in combination with fluorouracil as a radiosensitizing chemotherapy regimen in participants receiving chemoradiation.
Surgical removal of the bladder performed according to institutional standards.
Definitive bladder-preserving treatment consisting of external beam radiation therapy administered with concurrent radiosensitizing chemotherapy according to institutional standards and protocol specifications.
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