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A Randomized Phase II Study of Atezolizumab (MPDL3280A) plus Recombinant Human IL-7 (CYT107) in patients with locally advanced or metastatic urothelial carcinoma
This phase II trial studies how well atezolizumab when given with glycosylated recombinant human interleukin-7 (CYT107) works in treating participants with urothelial carcinoma that has spread to nearby tissue or lymph nodes, cannot be removed by surgery, or has spread to other places in the body. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. CYT107 is a biological product naturally made by the body that may stimulate the immune system to destroy tumor cells. Giving atezolizumab and CYT107 may work better in treating participants with locally advanced, inoperable, or metastatic urothelial carcinoma
The goals of this trial are to evaluate the safety and tolerability of the investigational treatment combination, and to determine whether the addition of CYT107 to atezolizumab improves the objective response rate achieved by atezolizumab alone in patients with advanced/non-resectable bladder cancer who are either not considered to be eligible for cisplatin-based treatment or have recurrent disease after platinum chemotherapy. Primary Objectives To determine the clinical efficacy of the investigational treatment combination. The primary endpoint will be the Objective Response Rate (ORR), defined by Complete Response (CR) or Partial Response (PR) as measured by RECIST v1.1.
Atezolizumab (Tecentriq); CYT107 ()