Erbitux (cetuximab)

P3, N=370, Active, not recruiting, AstraZeneca | Trial completion date: Sep 2025 --> Sep 2026

This overview provides a concise synthesis of targeted therapies under investigation or already in clinical use, including monoclonal antibodies against epidermal growth factor receptor (EGFR) (e.g., cetuximab) and immune checkpoint inhibitors (e.g., nivolumab, pembrolizumab), as well as inhibitors of programmed cell death protein 1 (PD-1) and its ligand (PD-L1) or agents targeting angiogenic and intracellular signaling pathways such as VEGF and mTOR...Metformin and statins, for instance, have demonstrated anti-proliferative and pro-apoptotic effects in preclinical OSCC models. Notably, recent evidence suggests that regular use of nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, may improve survival specifically in patients with PIK3CA-altered Head and Neck tumors, potentially through modulation of the COX-2/PGE2 axis. Although prospective evidence remains limited and somewhat heterogeneous, existing preclinical and observational studies suggest that these agents may improve survival and reduce treatment-related toxicity, further pointing to the relevance of molecular stratification in guiding future repurposing strategies. This article aims to map the current therapeutic landscape, highlighting both established molecular targets and emerging repositioned drugs in the management of OSCC and OPSCC.

P1, N=188, Recruiting, Alterome Therapeutics, Inc. | N=130 --> 188

P2, N=150, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting

This study aimed to compare the efficacy and safety of neoadjuvant immunochemotherapy (NAIC), neoadjuvant immunotherapy plus cetuximab (NAI-CTX), and neoadjuvant chemotherapy (NAC) in patients with locally advanced OSCC...The efficacy of neoadjuvant therapy was primarily associated with PD-L1 expression levels rather than the number of treatment cycles. NAIC demonstrates superior pathologic responses and survival benefits compared to both NAI-CTX and NAC, establishing it as a highly promising neoadjuvant strategy for locally advanced OSCC.

P3, N=500, Recruiting, Johnson & Johnson Enterprise Innovation Inc. | Trial completion date: Dec 2027 --> Jun 2028

P2, N=408, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed

Glecirasib monotherapy and its combination with cetuximab represent potential treatment options for patients with advanced, refractory colorectal cancer harbouring KRASG12C mutations. The promising efficacy and safety support further exploration of glecirasib-based combinations in earlier lines of treatment.

Our findings directly inform clinical guidelines, address gaps in current therapeutic decision-making. Durvalumab or pembrolizumab combined with GC are optimal first-line regimens for advanced BTC, balancing survival benefits and safety. Sintilimab plus anlotinib combined with GC demonstrates superior PFS but requires further validation. While EGFR inhibitors plus chemotherapy demonstrate potential in KRAS wild-type patients, confirmation in large-scale RCTs is required. PD-L1 expression may represent a promising predictive biomarker for response to PD-1 inhibitor therapy.

P3, N=89, Completed, Incyte Corporation | Active, not recruiting --> Completed

P2, N=70, Recruiting, Zhejiang University

P1, N=36, Recruiting, University of Chicago | Active, not recruiting --> Recruiting