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<p>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 [<sup>18</sup>F]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: <a href="https://clinicaltrials.gov/study/NCT04620200">NCT04620200</a>.</p>

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Neoadjuvant ipilimumab and nivolumab in resectable cutaneous squamous cell carcinoma: a randomized phase 2 trial

  • 期刊论文

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  • 发表日期：

    2025年10月8日

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  • Sabine E. Breukers,
  • Joleen J. H. Traets,
  • Stan W. van Dijk,
  • Mercedes Machuca Ostos,
  • Itske Fraterman,
  • Robert D. Crommelin,
  • Hedda van der Hulst,
  • Xiaohang Qiao,
  • Thomas Boere,
  • Lonneke V. van de Poll-Franse,
  • Valesca Retèl,
  • Vincent van der Noort,
  • Joris L. Vos,
  • Alexandra G. L. Toppenberg,
  • Martijn van der Heijden,
  • Francesco Missale,
  • Fons Balm,
  • Michiel van den Brekel,
  • Richard Dirven,
  • M. Baris Karakullukcu,
  • Luc Karssemakers,
  • W. Martin C. Klop,
  • Peter J.F.M Lohuis,
  • Willem H. Schreuder,
  • Ludi E. Smeele,
  • Lilly-Ann van der Velden,
  • Elsemieke Plasmeijer,
  • Laura A. Smit,
  • Jan Paul de Boer,
  • Arash Navran,
  • Bram Westerink,
  • Petra K. de Koekkoek-Doll,
  • Jonas Castelijns,
  • Maurits Wondergem,
  • Wouter V. Vogel,
  • Anke Kuijpers,
  • Winan J. van Houdt,
  • Suzanne Onderwater,
  • Esther Maas-Bannink,
  • Sten Cornelissen,
  • Annegien Broeks,
  • Bernard M. Tijink,
  • Lot A. Devriese,
  • Remco de Bree,
  • Christian U. Blank,
  • Ton N. Schumacher,
  • Daniela S. Thommen,
  • John B.A.G. Haanen,
  • Charlotte L. Zuur

摘要

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.