Also known as: oral head and neck cancer
CEL-SCI said it expects to begin summer 2026 enrollment in a 212-patient U.S. confirmatory registration study of Multikine in head and neck cancer. The company also said it submitted a Breakthrough Medicine Designation application in Saudi Arabia and reported quarterly net loss of $5.5 million.
GeoVax is advancing Gedeptin toward a Phase 2 trial in head and neck cancer and has secured an exclusive license from Emory University for Gedeptin-ICI combination technology. The therapy has Orphan Drug Designation for oral and pharyngeal cancers.
A novel therapeutic vaccine using structural nanomedicine principles has shown promising results against HPV-driven cancers in preclinical models. The spherical nucleic acid vaccine design significantly slowed tumor growth and extended survival by generating potent T-cell responses. Unlike preventive HPV vaccines, this approach is designed to treat established cancers caused by the virus.
Immunotherapy is increasingly used in earlier cancer stages before or after surgery across seven tumor areas. Research shows neoadjuvant and adjuvant immunotherapy can reduce recurrence risk and improve immune recognition of tumor cells. However, challenges remain including side effects, costs, and determining which patients benefit most from earlier treatment.
The U.S. FDA has granted Fast Track designation to FluoGuide's FG001 as an intraoperative imaging agent for high-grade glioma surgical resection. The designation follows IND clearance in January and enables accelerated development and regulatory review.
Meta-analysis of 23 trials finds neoadjuvant chemoimmunotherapy achieved 66% major pathologic response in head and neck cancer patients compared to 18% for dual-agent and 6% for single-agent immunotherapy, though survival impact remains unclear.
Phase 2 trial of amivantamab in recurrent/metastatic adenoid cystic carcinoma achieved 72.2% clinical benefit rate with good tolerability. Combination therapy with pembrolizumab is being evaluated in head and neck squamous cell cancer.
The U.S. Food and Drug Administration has cleared FluoGuide's Investigational New Drug application for FG001, enabling the company to proceed with a Phase 2 registration trial in high-grade glioma patients with first enrollment expected in Q2 2026.
The U.S. FDA granted Breakthrough Therapy Designation for subcutaneous Rybrevant Faspro as monotherapy for adults with advanced head and neck squamous cell carcinoma, based on Phase 1b/2 study data showing rapid and durable responses.
The FDA has approved a monthly dosing schedule for Rybrevant Faspro in EGFR-mutated NSCLC and granted breakthrough therapy designation for the drug as monotherapy in HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma after prior therapy.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07583914 |
Safety, Tolerability, and Preliminary Antitumor Activity of Non-Cationic Peptide-CD47 siRNA in Advanced Solid Tumors |
NOT_YET_RECRUITING | PHASE1 |
| NCT07583316 |
A Phase 1 First-in-Human Study of CRPA1A2, a MAGE-A1/HLA-A*02:01 Bispecific T-Cell Engager, in Patients With Solid Tumors |
NOT_YET_RECRUITING | PHASE1 |
| NCT07558447 |
Extracellular Vesicles and Chemotherapy-Induced Peripheral Neuropathy |
RECRUITING | NA |
| NCT07557225 |
18F-T2 PET/CT Imaging for CAIX Positive Solid Tumors |
RECRUITING | NA |
| NCT07556367 |
Post-Radiation Oral Health in Underserved Head and Neck Cancer Patients |
RECRUITING | NA |
| NCT07550049 |
Comprehensive Oncogenomic Mapping and Exploration in Thoracic and Head & Neck Oncology |
NOT_YET_RECRUITING | |
| NCT07532538 |
A Machine Learning-Based Risk Prediction Model for Head and Neck Cancerous Lesions |
NOT_YET_RECRUITING | |
| NCT07528495 |
A Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's |
RECRUITING | PHASE2/PHASE3 |
| NCT07524894 |
Staph Nasal Decolonization to Improve Function and Feeding |
NOT_YET_RECRUITING | PHASE2 |
| NCT07524114 |
Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception (SHERLOCK) |
RECRUITING |
