This defined as, at least 5 instillations of induction BCG and an overall of at least 7 instillations of BCG within 9 months.įor patients to be unresponsive to BCG, they must have persistent high risk NMIBC at 6 months (±4 weeks) after adequate BCG or recurrent high risk NMIBC within 9 months of the last BCG instillation despite having received adequate BCG.įurthermore, an eligible patient’s most recent cystoscopy must have High Grade Ta or any Grade T1 without CIS. The approval was based on data from KEYNOTE-057 ( NCT02625961 ), a multicenter, open-label, single-arm trial in 96 patients with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. This trial targets patients with High Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy.Įligible patients must have first received an adequate course of BCG therapy. ![]() The MK-3475-057 study is a Phase II Clinical Trial for Bladder Cancer. Methods: Key inclusion criteria include age 18 y BCG-unresponsive NMIBC (high-grade Ta, T1, and/or carcinoma in situ CIS despite adequate BCG treatment) ineligible for/or declines radical. KEYNOTE-361 is a randomised, open-label, phase 3 trial of patients aged at least 18 years, with untreated, locally advanced, unresectable, or metastatic urothelial carcinoma, with an Eastern Cooperative Oncology Group performance status of up to 2. Patients who fail to adequately respond to BCG are escalated to radical cystectomy to remove persistent or recurrent disease. KEYNOTE-057 was a single-arm phase 2 study that evaluated pembrolizumab in bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). Bladder Cancer – MK3475-057 Study (Clinical Trial): KEYNOTE-057 (NCT02625961) is a single-arm, open-label, phase 2 study to evaluate pembrolizumab in pts with high-risk NMIBC unresponsive to BCG. KEYNOTE-057 Rationale and Findings Standard treatment of high-risk NMIBC involves transurethral resection of the bladder tumor (TURBT) followed by intravesical BCG therapy to eradicate any residual disease.
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