![]() Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial. Pembrolizumab monotherapy for the treatment of high-risk non-muscle-invasive bladder cancer unresponsive to BCG (KEYNOTE-057): an open-label, single-arm, multicentre, phase 2 study. Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361): a randomised, open-label, phase 3 trial. First-line pembrolizumab (pembro) in cisplatin-ineligible patients with advanced urothelial cancer (UC): response and survival results up to five years from the KEYNOTE-052 phase 2 study. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. Enrollment will continue until approximately 260 patients have enrolled.Bellmunt, J. Primary end points are complete response (cohort A) and disease-free survival (cohort B) secondary end points include progression-free survival, overall survival, duration of response, and the relationship between PD-L1 expression and response to treatment. Adverse events (AEs) will be monitored throughout the study and for 30 days after end of treatment (90 days for serious AEs and events of clinical interest) and graded per Common Terminology Criteria for Adverse Events version 4.0. Low-grade Ta recurrence will not be considered treatment failure these patients may undergo repeat TURBT and remain on treatment. At 18 months, patients with no evidence of disease may discontinue treatment. CT imaging will be used to assess for metastatic or nodal disease. ![]() Response will be assessed using cystoscopy and urine cytology every 12 weeks for the first 2 years, every 24 weeks for the next 2 years, and every 52 weeks thereafter. ![]() Patients will enter cohorts based on presence (cohort A) or absence (cohort B) of CIS as determined by tissue pathology at screening. Patients will receive pembrolizumab 200 mg once every 3 weeks for 24 months or until disease recurrence, progression, or unacceptable toxicity. Eligible patients must have undergone ≥2 cystoscopic procedures with the most recent ≤8 weeks before study start, including complete TURBT (tissue sample must be available). Eligibility criteria include age ≥18 years, histologically confirmed diagnosis of high-risk, BCG-unresponsive NMIBC (high-grade Ta, T1, and/or carcinoma in situ despite adequate BCG treatment), ineligible for or declined radical cystectomy, and Eastern Cooperative Oncology Group performance status 0-2. Methods: KEYNOTE-057 (NCT02625961) is an open-label, phase 2 study designed to evaluate the efficacy and safety of the anti–PD-1 antibody pembrolizumab in patients with high-risk, BCG-unresponsive NMIBC. PD-L1 is widely expressed in urothelial tumors, providing a therapeutic rationale for targeting this pathway in NMIBC. The programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) pathway is frequently altered in cancer, leading to inhibition of active T-cell–mediated immune surveillance of tumors. Background: A large percentage of patients with NMIBC experience disease recurrence/progression after standard-of-care therapy with transurethral resection of bladder tumor (TURBT) and intravesical BCG instillation.
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