Last updated on February 2020

Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Transitional Cell Carcinoma


Brief description of study

TITAN-TCC (0416-ASG) is a Phase 2, open-label study of nivolumab (BMS-936558) monotherapy with additional nivolumab/ipilimumab "boost" cycles in previously untreated* and platinum-based pretreated, 2nd and 3rd line, advanced or metastatic transitional cell carcinoma subjects. Nivolumab is a fully human PD-1 antibody which blocks the respective immune checkpoint in a ligand (PD-L1/PD-L2) independent manner.

[*Update from Jan-2020: First-line cohort was stopped and the inclusion of these patients was terminated]

Detailed Study Description

This is a Phase 2, single arm study of a tailored immunotherapy approach with nivolumab in adult ( 18 years) subjects with previously untreated (1st line)* or pretreated (2nd and 3rd line), surgically unresectable or metastatic TCC (further designated "advanced TCC"). The study targets to recruit 130 untreated (1st line) and 120 pretreated (2nd / 3rd line) patients, respectively. Tumor tissue obtained at least 2 years prior to screening must be available for a central pathology assessment. Subjects must have advanced (not amenable to curative surgery or radiation) or metastatic TCC, and must not have received more than two prior platinum-based chemotherapies for the treatment of advanced TCC.

[*Update from Jan-2020: First-line cohort was stopped and the inclusion of these patients was terminated. According protocol v.5.0 80 2nd/3rd-line patients need to be included]

Clinical Study Identifier: NCT03219775

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