Last updated on February 2019

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

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Brief description of study

TITAN RCC (0216-ASG) is a Phase 2, open-label study of nivolumab monotherapy with additional nivolumab/ipilimumab "boost" cycles in previously untreated and pretreated (2nd line), advanced or metastatic renal cell carcinoma (mRCC) subjects with intermediate and high risk disease according to IMDC.

Detailed Study Description

The primary object is to estimate the Objective response rate (ORR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of the TITAN regimen in untreated (1st line) and pretreated (2nd line) subjects with International Metastatic RCC Database Consortium (IMDC) intermediate and high risk, advanced Renal cell carcinoma (RCC) with clear cell component