van Dorp, Jeroen and Pipinikas, Christodoulos and Suelmann, Britt B. M. and Mehra, Niven and van Dijk, Nick and Marsico, Giovanni and van Montfoort, Maurits L. and Hackinger, Sophie and Braaf, Linde M. and Amarante, Tauanne and van Steenis, Charlaine and McLay, Kirsten and Daletzakis, Antonios and van den Broek, Daan and van de Kamp, Maaike W. and Hendricksen, Kees and de Feijter, Jeantine M. and Boellaard, Thierry N. and Meijer, Richard P. and van der Heijden, Toine G. and Rosenfeld, Nitzan and van Rhijn, Bas W. G. and Jones, Greg and van der Heijden, Michiel S. (2023) High- or low-dose preoperative ipilimumab plus nivolumab in stage III urothelial cancer: the phase 1B NABUCCO trial. NATURE MEDICINE, 29 (3). 588-+. ISSN 1078-8956, 1546-170X
Full text not available from this repository. (Request a copy)Abstract
Cohort 1 of the phase 1B NABUCCO trial showed high pathological complete response (pCR) rates with preoperative ipilimumab plus nivolumab in stage III urothelial cancer (UC). In cohort 2, the aim was dose adjustment to optimize responses. Additionally, we report secondary endpoints, including efficacy and tolerability, in cohort 2 and the association of presurgical absence of circulating tumor DNA (ctDNA) in urine and plasma with clinical outcome in both cohorts. Thirty patients received two cycles of either ipilimumab 3 mg kg(-1) plus nivolumab 1 mg kg(-1) (cohort 2A) or ipilimumab 1 mg kg(-1) plus nivolumab 3 mg kg(-1) (cohort 2B), both followed by nivolumab 3 mg kg(-1). We observed a pCR in six (43%) patients in cohort 2A and a pCR in one (7%) patient in cohort 2B. Absence of urinary ctDNA correlated with pCR in the bladder (ypT0Nx) but not with progression-free survival (PFS). Absence of plasma ctDNA correlated with pCR (odds ratio: 45.0; 95% confidence interval (CI): 4.9-416.5) and PFS (hazard ratio: 10.4; 95% CI: 2.9-37.5). Our data suggest that high-dose ipilimumab plus nivolumab is required in stage III UC and that absence of ctDNA in plasma can predict PFS.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | NEOADJUVANT CHEMOTHERAPY; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Urologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 09 Apr 2024 13:02 |
| Last Modified: | 09 Apr 2024 13:02 |
| URI: | https://pred.uni-regensburg.de/id/eprint/60785 |
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