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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 by Marc-Oliver Grimm; Christine Barbara Grün; Günter Niegisch; Martin Pichler; Florian Roghmann; Bernd Schmitz-Dräger; Gustavo Baretton; Marc Schmitz; Christian Bolenz; Susan Foller; Katharina Leucht; Ulrike Schumacher; Martin Schostak; Johannes Meran; Wolfgang Loidl; Friedemann Zengerling is a Medicine article available to read on EtoBox.

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Background Nivolumab is used after platinum-based chemotherapy in patients with metastatic urothelial carcinoma. Studies suggest improved outcomes for dual checkpoint inhibition with high ipilimumab doses. We aimed to examine the safety and activity of nivolumab induction and high-dose ipilimumab as an immunotherapeutic boost as a second-line treatment for patients with metastatic urothelial carcinoma. Methods TITAN-TCC is a multicentre, single-arm, phase 2 trial done at 19 hospitals and cancer centres in Germany and Austria. Adults aged 18 years or older with histologically confirmed metastatic or surgically unresectable urothelial cancer of the bladder, urethra, ureter, or renal pelvis were eligible. Patients had to have progression during or after first-line platinum-based chemotherapy and up to one more second-line or third-line treatment, a Karnofsky Performance Score of 70 or higher, and measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1. After four doses of intravenous nivolumab 240 mg induction monotherapy every 2 weeks, patients with a partial or complete response at week 8 continued maintenance nivolumab, whereas those with stable or progre

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Author

Marc-Oliver Grimm; Christine Barbara Grün; Günter Niegisch; Martin Pichler; Florian Roghmann; Bernd Schmitz-Dräger; Gustavo Baretton; Marc Schmitz; Christian Bolenz; Susan Foller; Katharina Leucht; Ulrike Schumacher; Martin Schostak; Johannes Meran; Wolfgang Loidl; Friedemann Zengerling

Publisher

Elsevier BV

Published

2023

Language

EN

Field

Medicine (Health Sciences)