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

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

Timeline

Start

2017-07-06

Primary completion

2021-09-16

Completion

2023-02-18

Outcome

Met primary endpoint

paper This objective response rate was significantly higher than the prespecified threshold of 20% or less (33% [90% CI 24-42]; p=0·0049). PMID 36868252 ↗

Publications

• Grimm MO, Schostak M, Grun CB, Loidl W, Pichler M, Zimmermann U, Schmitz-Drager B, Steiner T, Roghmann F, Niegisch G, Bolenz C, Schmitz M, Baretton G, Leucht K, Schumacher U, Foller S, Zengerling F, Meran J; TITAN-TCC Study Group. Nivolumab + Ipilimumab as Immunotherapeutic Boost in Metastatic Urothelial Carcinoma: A Nonrandomized Clinical Trial. JAMA Oncol. 2024 Jun 1;10(6):755-764. doi: 10.1001/jamaoncol.2024.0938.
• Grimm MO, Grun CB, Niegisch G, Pichler M, Roghmann F, Schmitz-Drager B, Baretton G, Schmitz M, Bolenz C, Foller S, Leucht K, Schumacher U, Schostak M, Meran J, Loidl W, Zengerling F. Tailored immunotherapy approach with nivolumab with or without ipilimumab in patients with advanced transitional cell carcinoma after platinum-based chemotherapy (TITAN-TCC): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2023 Apr;24(4):347-359. doi: 10.1016/S1470-2045(23)00053-0. Epub 2023 Feb 28.
• Grimm MO, Schmitz-Drager BJ, Zimmermann U, Grun CB, Baretton GB, Schmitz M, Foller S, Leucht K, Schostak M, Zengerling F, Schumacher U, Loidl W, Meran J. Tailored Immunotherapy Approach With Nivolumab in Advanced Transitional Cell Carcinoma. J Clin Oncol. 2022 Jul 1;40(19):2128-2137. doi: 10.1200/JCO.21.02631. Epub 2022 Mar 11.

Drugs

Indications