Breukers, Sabine E. and Traets, Joleen J. H. and van Dijk, Stan W. and Ostos, Mercedes Machuca and Fraterman, Itske and Crommelin, Robert D. and van der Hulst, Hedda and Qiao, Xiaohang and Boere, Thomas and van de Poll-Franse, Lonneke V. and Retel, Valesca and van der Noort, Vincent and Vos, Joris L. and Toppenberg, Alexandra G. L. and van der Heijden, Martijn and Missale, Francesco and Balm, Fons and van den Brekel, Michiel and Dirven, Richard and Karakullukcu, M. Baris and Karssemakers, Luc and Klop, W. Martin C. and Lohuis, Peter J. F. M. and Schreuder, Willem H. and Smeele, Ludi E. and van der Velden, Lilly-Ann and Plasmeijer, Elsemieke and Smit, Laura A. and de Boer, Jan Paul and Navran, Arash and Westerink, Bram and de Koekkoek-Doll, Petra K. and Castelijns, Jonas and Wondergem, Maurits and Vogel, Wouter V. and Kuijpers, Anke and van Houdt, Winan J. and Onderwater, Suzanne and Maas-Bannink, Esther and Cornelissen, Sten and Broeks, Annegien and Tijink, Bernard M. and Devriese, Lot A. and de Bree, Remco and Blank, Christian U. and Schumacher, Ton N. and Thommen, Daniela S. and Haanen, John B. A. G. and Zuur, Charlotte L. (2025) Neoadjuvant ipilimumab and nivolumab in resectable cutaneous squamous cell carcinoma: a randomized phase 2 trial. NATURE MEDICINE, 31 (12). pp. 4055-4064. ISSN 1078-8956, 1546-170X
Full text not available from this repository. (Request a copy)Abstract
Patients with cutaneous squamous cell carcinoma (CSCC) frequently require mutilating surgery and adjuvant radiotherapy (RT). CSCC has been demonstrated to be highly responsive to neoadjuvant anti-PD-1 immune-checkpoint blockade (ICB). However, efficacy and safety of neoadjuvant anti-PD-1 combined with anti-CTLA-4 are lacking. In the MATISSE trial, the primary objective was met to investigate the pathological response rate on neoadjuvant nivolumab (NIVO) and nivolumab plus ipilimumab (NIVO + IPI) at the time of standard of care (SOC: surgery +/- RT), defined as the proportion of remaining viable tumor cells in the surgical specimen. Fifty patients with stage I-IVa resectable CSCC were treated with NIVO (weeks 0 and 2) or NIVO (weeks 0 and 2) plus low-dose IPI (week 0) before SOC in week 4. The median follow-up was 31 months. Forty patients underwent SOC; 9 of 20 (45%) patients who received NIVO and 10 of 20 (50%) patients who received NIVO + IPI reached a major pathological response (MPR) and 2 of 20 (10%) patients with NIVO and 6 of 20 (30%) with NIVO + IPI reached a partial pathological response (PPR), resulting in pathological response rates of 55% and 80%, respectively. MPR or PPR was accompanied by 2-year disease-specific survival (DSS) of 100%. ICB was safe with 12% (NIVO) and 8% (NIVO + IPI), grade 3, immune-related toxicity without surgical delays. Ten patients opted to decline surgery and RT, of whom nine reached durable organ preservation and a clinical complete remission on two ICB infusions alone, accompanied by a 2-year DSS of 100% and favorable health-related quality of life. Early changes in [18F]fluorodeoxyglucose positron emission tomography/computed tomography's total lesion glycolysis can safely select patients for response-guided treatment de-escalation in future trials. The ClinicalTrials.gov identifier is: NCT04620200.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | RISK-FACTORS; CANCER; IMMUNOTHERAPY; CEMIPLIMAB; SURVIVAL; OUTCOMES; DISEASE; COHORT; HEAD; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Hals-Nasen-Ohren-Heilkunde |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 31 Mar 2026 06:27 |
| Last Modified: | 31 Mar 2026 06:27 |
| URI: | https://pred.uni-regensburg.de/id/eprint/67892 |
Actions (login required)
 |
View Item |
