NCT02917772

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

A Phase II Single Arm Clinical Trial of a Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Carcinoma, Renal Cell
• Clear-cell Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab/Ipilimumab	* Induction: Mono-Therapy with Nivolumab (240 mg i.V. / Q2W x 8) * If CR/PR: Nivolumab Maintenance Mono-Therapy (240 mg i.V. / Q2W) * If SD/PD: Nivolumab/Ipilimumab "Boost 1+2"-Combination Therapy (Nivo 3 mg/kg i.V. and Ipi 1 mg/kg i.V. / Q3W x 2) * If CR/PR: Nivolumab Maintenance Mono-Therapy (240 mg i.V. / Q2W) * If SD/PD: Nivolumab/Ipilimumab "Boost 3+4"-Combination Therapy (Nivo 3 mg/kg i.V. and Ipi 1 mg/kg i.V. / Q3W x 2) * If CR/PR/SD: Nivolumab Maintenance Mono-Therapy (240 mg i.V. / Q2W)

Timeline

• Start date: 2016-10-01
• Primary completion: 2021-10-01
• Completion: 2022-10-01
• First posted: 2016-09-28
• Last updated: 2022-10-06

Locations

35 sites across 8 countries: Austria, Belgium, Czechia, France, Germany, Italy, Spain, United Kingdom