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

Sponsor
AIO-Studien-gGmbH
Study ID
NCT02917772
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab/Ipilimumab — BIOLOGICAL
    * 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)

Study Details

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.

Key Dates

Start date
Oct 31, 2016
Status verified
Oct 2022
Primary completion
Oct 31, 2021
Completion
Oct 31, 2022

Study Design

Enrollment
200 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab/Ipilimumab
    * Induction: Mono-Therapy with Nivolumab * If CR/PR: Nivolumab Maintenance Mono-Therapy * If SD/PD: Nivolumab/Ipilimumab "Boost 1+2"-Combination Therapy * If CR/PR: Nivolumab Maintenance Mono-Therapy * If SD/PD: Nivolumab/Ipilimumab "Boost 3+4"-Combination Therapy * If CR/PR/SD: Nivolumab Maintenance Mono-Therapy

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: until 30 weeks after last patient first treatment, LPFT ]

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