TY  - JOUR
AU  - Grimm, Marc-Oliver
AU  - Esteban, Emilio
AU  - Barthélémy, Philippe
AU  - Schmidinger, Manuela
AU  - Busch, Jonas
AU  - Valderrama, Begoña P
AU  - Charnley, Natalie
AU  - Schmitz, Marc
AU  - Schumacher, Ulrike
AU  - Leucht, Katharina
AU  - Foller, Susan
AU  - Baretton, Gustavo
AU  - Duran, Ignacio
AU  - de Velasco, Guillermo
AU  - Priou, Frank
AU  - Maroto, Pablo
AU  - Albiges, Laurence
TI  - Tailored immunotherapy approach with nivolumab with or without nivolumab plus ipilimumab as immunotherapeutic boost in patients with metastatic renal cell carcinoma (TITAN-RCC): a multicentre, single-arm, phase 2 trial.
JO  - The lancet / Oncology
VL  - 24
IS  - 11
SN  - 1470-2045
CY  - London
PB  - The Lancet Publ. Group
M1  - DKFZ-2023-02099
SP  - 1252-1265
PY  - 2023
N1  - 2023 Nov;24(11):1252-1265
AB  - Nivolumab plus ipilimumab is approved as first-line regimen for intermediate-risk or poor-risk metastatic renal cell carcinoma, and nivolumab monotherapy as second-line therapy for all risk groups. We aimed to examine the efficacy and safety of nivolumab monotherapy and nivolumab plus ipilimumab combination as an immunotherapeutic boost after no response to nivolumab monotherapy in patients with intermediate-risk and poor-risk clear-cell metastatic renal cell carcinoma.TITAN-RCC is a multicentre, single-arm, phase 2 trial, done at 28 hospitals and cancer centres across Europe (Austria, Belgium, Czech Republic, France, Germany, Italy, Spain, and the UK). Adults (aged ≥18 years) with histologically confirmed intermediate-risk or poor-risk clear-cell metastatic renal cell carcinoma who were formerly untreated (first-line population) or pretreated with one previous systemic therapy (anti-angiogenic or temsirolimus; second-line population) were eligible. Patients had to have a Karnofsky Performance Status score of at least 70 and measurable disease per Response Evaluation Criteria in Solid Tumours (version 1.1). Patients started with intravenous nivolumab 240 mg once every 2 weeks. On early progressive disease (week 8) or non-response at week 16, patients received two or four doses of intravenous nivolumab (3 mg/kg) and ipilimumab (1 mg/kg) boosts (once every 3 weeks), whereas responders continued with intravenous nivolumab (240 mg, once every 2 weeks), but could receive two to four boost doses of nivolumab plus ipilimumab for subsequent progressive disease. The primary endpoint was confirmed investigator-assessed objective response rate in the full analysis set, which included all patients who received at least one dose of study medication; safety was also assessed in this population. An objective response rate of more than 25
LB  - PUB:(DE-HGF)16
C6  - pmid:37844597
DO  - DOI:10.1016/S1470-2045(23)00449-7
UR  - https://inrepo02.dkfz.de/record/284788
ER  -