NRG-HN014 (C-PRE): A randomized phase III study of neoadjuvant immunotherapy with response-adapted treatment versus standard-of-care treatment for patients with resectable stage III-IV (M0) cutaneous squamous cell carcinoma (cSCC)
Recommended Citation
Gross N, Atwood K, Ashford B, Barker C, Chen Y, Nagarajan P, Rischin D, Schmitt N, Tam S, Wise-Draper TM, Ward M, Wu X, Yom SS. NRG-HN014 (C-PRE): A randomized phase III study of neoadjuvant immunotherapy with response-adapted treatment versus standard-of-care treatment for patients with resectable stage III-IV (M0) cutaneous squamous cell carcinoma (cSCC). Ann Oncol 2025; 36:1.
Document Type
Conference Proceeding
Publication Date
9-1-2025
Publication Title
Ann Oncol
Keywords
Oncology
Abstract
Cutaneous squamous cell carcinoma (CSCC) is associated with immune system dysfunction, and prior research has demonstrated durable pathologic responses and favorable survival using neoadjuvant anti-programmed death-1 (PD-1) therapy. NRG-HN014 (C-PRE) is an NCI-sponsored, open-label, randomized, phase 3 trial (NCT06568172) evaluating the efficacy of neoadjuvant cemiplimab with response-adapted treatment for advanced stage, resectable cSCC. Trial design: Patients with histologically confirmed resectable stage III-IV (M0) CSCC will be enrolled, including select immunosuppressed patients. A total of 420 patients in the US, Canada and Australia will be randomly assigned 1:1 to Arm 1 (standard-of-care) or Arm 2 (neoadjuvant cemiplimab with response-adapted treatment). Patients in Arm 1 will proceed directly to surgery and receive adjuvant radiation as indicated by pathology. Patients in Arm 2 will receive cemiplimab 350 mg IV Q3W (up to 4 doses) followed by response-adapted oncologic surgery. Patients in Arm 2 with a complete pathologic response (pCR) will receive no further treatment. The remaining patients in Arm 2 with
Volume
36
First Page
1
