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GU16-257: Neoadjuvant Gemcitabine, Cisplatin, Plus Nivolumab in Patients with Muscle-Invasive Bladder Cancer with Selective Bladder Sparing

This is a phase 2 trial seeking to define the safety and activity of gemcitabine, cisplatin, plus nivolumab as neoadjuvant therapy in patients with muscle-invasive bladder cancer and to define the role of clinical complete response (cCR) in predicting benefit in patients opting to avoid cystectomy.

Primary Objectives

  1. Determine the cCR rate with gemcitabine, cisplatin, plus nivolumab;
  2. Determine the ability of cCR (cT0 or cTa) to predict benefit from treatment. Benefit was defined as, among the patients achieving a cCR, either being (a) 2-year metastasis-free in patients forgoing immediate cystectomy or (b) < ypT1N0 in patients electing immediate cystectomy.

Findings

Seventy-six patients were enrolled; of these, 33 achieved a cCR (43%, 95% confidence interval (CI): 32%, 55%), and 32 of the 33 who achieved a cCR opted to forgo immediate cystectomy. The positive predictive value of cCR was 0.97 (95% CI: 0.91, 1).