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

NCT03219775 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2021-11-03

No results posted yet for this study

Summary

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.

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

Conditions

Interventions

BIOLOGICAL

Nivolumab/Ipilimumab

* 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)

Sponsors & Collaborators

Principal Investigators

  • Marc-Oliver Grimm, Prof. Dr. · Jena University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-06
Primary Completion
2021-09-16
Completion
2023-02-18

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03219775 on ClinicalTrials.gov