TY  - JOUR
AU  - Grimm, Marc-Oliver
AU  - Grün, Christine Barbara
AU  - Niegisch, Günter
AU  - Pichler, Martin
AU  - Roghmann, Florian
AU  - Schmitz-Dräger, Bernd
AU  - Baretton, Gustavo
AU  - Schmitz, Marc
AU  - Bolenz, Christian
AU  - Foller, Susan
AU  - Leucht, Katharina
AU  - Schumacher, Ulrike
AU  - Schostak, Martin
AU  - Meran, Johannes
AU  - Loidl, Wolfgang
AU  - Zengerling, Friedemann
TI  - 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.
JO  - The lancet  / Oncology
VL  - 24
IS  - 4
SN  - 1470-2045
CY  - London
PB  - The Lancet Publ. Group
M1  - DKFZ-2023-00443
SP  - 347-359
PY  - 2023
N1  - 2023 Apr;24(4):347-359
AB  - 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.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 progressive disease (non-responders) at week 8 received a boost of two or four doses of intravenous nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks. Patients who subsequently had progressive disease during nivolumab maintenance also received a boost, using this schedule. The primary endpoint was the confirmed investigator-assessed objective response rate in the intention-to-treat population and had to exceed 20
LB  - PUB:(DE-HGF)16
C6  - pmid:36868252
DO  - DOI:10.1016/S1470-2045(23)00053-0
UR  - https://inrepo02.dkfz.de/record/274133
ER  -