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

  • STATUS
    Not Recruiting
  • participants needed
    200
  • sponsor
    AIO-Studien-gGmbH
Updated on 23 January 2021
platelet count
calcium
systemic therapy
measurable disease
carcinoma
vegf
growth factor
metastasis
neutrophil count
bone metastases
programmed cell death 1 ligand 1
nivolumab
ipilimumab
temsirolimus
curative surgery
nephrectomy
metastatic renal cell carcinoma
advanced renal cell carcinoma

Summary

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.

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

Details
Condition Renal Cell Carcinoma, Clear Cell Metastatic Renal Cell Carcinoma
Treatment Nivolumab/Ipilimumab
Clinical Study IdentifierNCT02917772
SponsorAIO-Studien-gGmbH
Last Modified on23 January 2021

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