Libtayo (cemiplimab-rwlc)

P2, N=120, Not yet recruiting, Regeneron Pharmaceuticals | Trial completion date: Nov 2029 --> Dec 2030 | Initiation date: Mar 2025 --> Mar 2026 | Trial primary completion date: Apr 2027 --> Jun 2028

P1/2, N=240, Recruiting, Regeneron Pharmaceuticals | N=150 --> 240

P2, N=180, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Nov 2025 --> Feb 2026

P1/2, N=86, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Dec 2025 --> Mar 2026

P2, N=32, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Aug 2026 --> Dec 2027 | Trial primary completion date: Nov 2025 --> Jun 2027

P2, N=66, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

P2, N=108, Not yet recruiting, National Cancer Institute (NCI)

This report conducts a systematic review of four principal studies: ① The KEYNOTE-689 trial was the inaugural study to establish that "pembrolizumab combined with standard therapy" diminishes the risk of disease progression or mortality by 34% in patients with Programmed Cell Death-L1(PD-L1) CPS ≥ 10, resulting in Food and Drug Administration (FDA) approval; ② The NIVOPOSTOP trial revealed that adjuvant nivolumab alongside CRT significantly improved 3-year disease-free survival (DFS) (63.1% vs. 52.5%), with efficacy unaffected by PD-L1 status; ③ The C-POST trial indicated a substantial DFS advantage with adjuvant cemiplimab in high-risk skin squamous cell carcinoma (HR = 0.32);④ The NeoRTPC02 trial innovatively integrated low-dose radiotherapy with immune chemotherapy, achieving a pathological complete response(pCR) rate of 60.9%. Nonetheless, the ideal treatment approach, strategies for reducing radiation dosage, preservation of organ function, and selection of biomarkers necessitate additional confirmation. Future efforts must focus on interdisciplinary collaboration to enhance tailored precision treatment protocols, aiming to improve the 5-year survival rate of HNSCC while maintaining organ function and quality of life.

The patient was admitted and commenced on intravenous methylprednisolone, leading to symptom resolution within 7 days. Understanding the pathophysiological mechanisms underlying these toxicities is essential for optimizing treatment strategies, minimizing adverse effects without compromising ICI efficacy, and ultimately prolonging patient access to immunotherapy. Further research into immune-related dermatological conditions may also provide valuable insights into the molecular mechanisms governing endogenous dermatological diseases, offering new avenues for targeted dermatological therapies.

P2, N=74, Not yet recruiting, Università Vita-Salute San Raffaele

P2, N=44, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Initiation date: Nov 2025 --> Aug 2026

P2, N=160, Recruiting, Fondazione Ricerca Traslazionale