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

Sponsor
AIO-Studien-gGmbH
Study ID
NCT03219775
Phase
PHASE2
Status
Unknown

Conditions

  • Advanced Cancer
  • Metastatic Cancer
  • Transitional 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 4) * If CR/PR: Nivolumab Maintenance Mono-Therapy (240 mg i.V. / Q2W) * If SD/PD: Nivolumab/Ipilimumab "Boost 1+2"-Combination Therapy (Nivo1 mg/kg i.V. and Ipi3 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 1 mg/kg i.V. and Ipi 3 mg/kg i.V. / Q3W x 2) * If CR/PR/SD: Nivolumab Maintenance Mono-Therapy (240 mg i.V. / Q2W) * since June 5, 2019, the treatment in all four "boost" cycles (1+2) and (3+4) is performed with nivolumab 1 mg/kg + ipilimumab 3 mg/kg (NIVO1/IPI3)

Study Details

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

Key Dates

Start date
Jul 6, 2017
Status verified
Nov 2021
Primary completion
Sep 16, 2021
Completion
Feb 18, 2023

Study Design

Enrollment
169 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: max. months ]

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