^
    2d
    A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers (clinicaltrials.gov)
    P1/2, N=107, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2025
    Trial completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    PD-L1 negative
    |
    Jingzhuda (entinostat) • bintrafusp alfa (M7824) • PDS01ADC
    3d
    Therapeutic Advances and Challenges for the Management of HPV-Associated Oropharyngeal Cancer. (PubMed, Int J Mol Sci)
    Eight drugs have been approved by the FDA for HNC, including both generic and commercial forms: bleomycin sulfate, cetuximab (Erbitux), docetaxel (Taxotere), hydroxyurea (Hydrea), pembrolizumab (Keytruda), loqtorzi (Toripalimab-tpzi), methotrexate sodium (Trexall), and nivolumab (Opdivo). The most common drugs to treat HPV-associated OPC under these clinical trials and implemented as well for HPV-negative HNC include cisplatin, nivolumab, cetuximab, paclitaxel, pembrolizumab, 5-fluorouracil, and docetaxel...In this context, we identified most mutated genes found in HPV-associated OPC that can represent potential targets for drug development. These include TP53, PIK3CA, PTEN, NOTCH1, RB1, FAT1, FBXW7, HRAS, KRAS, and CDKN2A.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • RB1 (RB Transcriptional Corepressor 1) • NOTCH1 (Notch 1) • FBXW7 (F-Box And WD Repeat Domain Containing 7) • FAT1 (FAT atypical cadherin 1)
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Erbitux (cetuximab) • cisplatin • paclitaxel • docetaxel • 5-fluorouracil • Loqtorzi (toripalimab-tpzi) • methotrexate • bleomycin • hydroxyurea
    3d
    A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010) (MK-7902-010)-China Extension Study (clinicaltrials.gov)
    P3, N=112, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Jul 2026 --> Mar 2025 | Trial primary completion date: Jul 2026 --> Aug 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib)
    3d
    Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC (clinicaltrials.gov)
    P=N/A, N=220, Recruiting, UNC Lineberger Comprehensive Cancer Center | Trial completion date: Nov 2025 --> Nov 2033 | Trial primary completion date: Nov 2025 --> Nov 2033
    Trial completion date • Trial primary completion date
    4d
    Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma (clinicaltrials.gov)
    P2, N=30, Recruiting, Washington University School of Medicine | Trial completion date: Oct 2025 --> Oct 2027 | Trial primary completion date: Oct 2025 --> Oct 2027
    Trial completion date • Trial primary completion date • Surgery • Metastases
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    CDKN2A expression
    |
    CUE-101
    5d
    SURVEILLE-HPV: Evaluation of HPV16 Circulating DNA as Biomarker to Detect the Recurrence, in Order to Improve Post Therapeutic Surveillance of HPV16-driven Oropharyngeal Cancers (clinicaltrials.gov)
    P2, N=420, Recruiting, UNICANCER | Not yet recruiting --> Recruiting
    Enrollment open
    8d
    Pilot Trial of E Cigarettes in Pts Diagnosed With Cancer of the Head, Neck, and Lung (clinicaltrials.gov)
    P=N/A, N=0, Withdrawn, Ohio State University Comprehensive Cancer Center | N=40 --> 0 | Suspended --> Withdrawn
    Enrollment change • Trial withdrawal
    8d
    Saliva Testing for High-Risk Human Papillomavirus Infection Oral Cavity and Pharynx Cancer (clinicaltrials.gov)
    P=N/A, N=80, Not yet recruiting, Wake Forest University Health Sciences
    New trial
    10d
    Evaluation of salivary tumor necrosis factor α as a diagnostic biomarker in oral submucosal fibrosis and squamous cell carcinoma of the oral cavity and oropharynx: a cross sectional observational study. (PubMed, Front Oral Health)
    No significant difference in salivary TNF-α levels was noted among the OSMF, SCC and control groups. The study showed a positive correlation of TNF-α with increasing stages of OSMF but was not a reliable biomarker in the categorization of the same.
    Observational data • Journal
    |
    TNFA (Tumor Necrosis Factor-Alpha)
    10d
    p16 overexpression identifies oncogenic high-risk HPV infection in non-oropharyngeal squamous cell carcinoma of the head and neck. (PubMed, Head Neck)
    We conclude that HPV-positive non-OPSCC are associated with p16 overexpression and low levels of pRb and cyclin D1. High expression of pRb and cyclin D1 indicates HPV-negativity.
    Journal
    |
    CCND1 (Cyclin D1)
    |
    CCND1 overexpression • CCND1 expression
    10d
    Oropharynx (OPX) Biomarker Trial (clinicaltrials.gov)
    P=N/A, N=180, Recruiting, Mayo Clinic
    New trial
    15d
    A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer (clinicaltrials.gov)
    P2, N=225, Suspended, Regeneron Pharmaceuticals | Recruiting --> Suspended
    Trial suspension • Combination therapy • Metastases
    |
    Libtayo (cemiplimab-rwlc) • vidutolimod (CMP-001)
    15d
    Spark2: Neoadjuvant Targeting of Myeloid Cell Populations in Combination With Nivolumab in Head & Neck Ca (clinicaltrials.gov)
    P2, N=24, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Apr 2024 --> Aug 2024
    Trial primary completion date • Combination therapy • Surgery
    |
    Opdivo (nivolumab) • BMS-986253
    15d
    High Dose Steroid Therapy (Prednisone or Methylprednisolone) for the Improvement of Symptoms of Late Radiation-Associated Lower Cranial Neuropathy in Oropharyngeal Cancer Survivors (clinicaltrials.gov)
    P1/2, N=35, Recruiting, M.D. Anderson Cancer Center | Active, not recruiting --> Recruiting | N=15 --> 35
    Enrollment open • Enrollment change
    |
    methylprednisolone sodium succinate
    21d
    Immunoexpression of Ki67, P16 and Beta-catenin in precursor lesions of cutaneous squamous cell carcinoma. (PubMed, Rom J Morphol Embryol)
    The immunoreactivity to the investigated markers confirms the multistage skin carcinogenesis, and their involvement starting from the initiation phase of the cancer process. The importance of the studied markers in the evolution and prognosis of precancerous lesions of CSCC is also supported by the linear correlations revealed between the immunoexpressions of P16, Ki67 and the membranous immunoexpression of Beta-catenin in AK.
    Journal
    |
    CTNNB1 (Catenin (cadherin-associated protein), beta 1)
    |
    CTNNB1 expression
    22d
    HYHOPE: De-intensified Hypofractionated Radiation Therapy for HPV-associated Oropharynx Cancer (clinicaltrials.gov)
    P1, N=24, Active, not recruiting, University of Texas Southwestern Medical Center | Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Jun 2024 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    cisplatin
    23d
    Understanding exososmes: Part 3-therapeutic + diagnostic potential in dentistry. (PubMed, Periodontol 2000)
    In total 47 diagnostic studies revealed a role for salivary/crevicular fluid exosomes for the diagnosis of birth defects, cardiovascular disease, diabetes, gingival recession detection, gingivitis, irritable bowel syndrome, neurodegenerative disease, oral lichen planus, oral squamous cell carcinoma, oropharyngeal cancer detection, orthodontic root resorption, pancreatic cancer, periodontitis, peri-implantitis, Sjögren syndrome, and various systemic diseases. Hence, we characterize the exosomes as possessing "remarkable" potential, serving as a valuable tool for clinicians with significant advantages.
    Review • Journal
    |
    BMP2 (Bone Morphogenetic Protein 2)
    25d
    Neoadjuvant Sintilimab Combined With Reduction of Cycles of Chemotherapy in Resectable Oral Cavity or Oropharyngeal Squamous Cell Carcinoma (OOC-002) (clinicaltrials.gov)
    P2, N=43, Recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Trial primary completion date: Sep 2023 --> Sep 2024
    Trial primary completion date • Combination therapy
    |
    carboplatin • Tyvyt (sintilimab) • albumin-bound paclitaxel
    25d
    Human Papillomavirus-Attributable Head and Neck Cancers in India-A Systematic Review and Meta-Analysis. (PubMed, JCO Glob Oncol)
    The HPV-attributable fraction is considerably lower for OC, suggesting a negligible causative role of HPV in OC. A significant proportion of OPC and LC are attributed to HPV; however, their exact causative role is unclear because of the presence of other known risk factors.
    Retrospective data • Review • Journal
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A)
    26d
    A 22-year single institution review of 119 cases of salivary duct carcinoma. (PubMed, Laryngoscope Investig Otolaryngol)
    Trastuzumab administration was not associated with survival in HER-2-positive patients receiving chemotherapy...Factors associated with worse survival included nodal and distant metastases, perineural invasion, lymphovascular invasion, and tumor size. Level 3.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab)
    26d
    The Relationship of Grade, Stage and Tobacco Usage in Head and Neck Squamous Cell Carcinoma With p53, PIK3CA and MicroRNA Profiles. (PubMed, Cureus)
     Through the deciphering of complex miRNA patterns and their relationships with clinicopathology, this study attempted to increase our understanding of HNSCC. Some candidate miRNAs showing probable association with grade, stage and personal habits were identified, but larger studies are needed to confirm or refute the importance of these miRNAs.
    Journal
    |
    TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MIR155 (MicroRNA 155) • MIR21 (MicroRNA 21) • MIR20B (MicroRNA 20b) • MIR31 (MicroRNA 31) • MIR363 (MicroRNA 363) • MIR497 (MicroRNA 497) • MIR15A (MicroRNA 15a) • MIR218 (MicroRNA 218)
    |
    TP53 expression • miR-31-5p underexpression
    29d
    A Study of Gebasaxturev (V937) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (V937-013) (clinicaltrials.gov)
    P1/2, N=75, Terminated, Merck Sharp & Dohme LLC | Phase classification: P1b/2 --> P1/2 | Completed --> Terminated; Business Reasons
    Phase classification • Trial termination • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 negative
    |
    Keytruda (pembrolizumab) • Cavatak (gebasaxturev)
    29d
    MCC-19178: Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P1/2, N=95, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Mar 2024 --> Aug 2024
    Trial completion date • Metastases
    |
    Opdivo (nivolumab) • Erbitux (cetuximab)
    30d
    Depression and Adherence in Head and Neck Cancer (clinicaltrials.gov)
    P=N/A, N=185, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2023 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2026
    Trial completion date • Trial primary completion date • Adherence
    30d
    Men and Women Offering Understanding of Throat HPV (clinicaltrials.gov)
    P=N/A, N=1500, Active, not recruiting, Johns Hopkins Bloomberg School of Public Health | Trial completion date: Jun 2025 --> Jun 2028 | Trial primary completion date: Apr 2024 --> Apr 2025
    Trial completion date • Trial primary completion date
    30d
    A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer (clinicaltrials.gov)
    P1/2, N=72, Not yet recruiting, Theravectys S.A.
    New P1/2 trial • Viral vector
    1m
    Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer (clinicaltrials.gov)
    P2, N=45, Recruiting, Ohio State University Comprehensive Cancer Center
    New P2 trial • Circulating tumor DNA
    |
    cisplatin • carboplatin • paclitaxel
    1m
    CXCL9 mediating the effect of thyroid disorders on oral and oropharyngeal cancer risk: a mediation Mendelian randomization study. (PubMed, J Stomatol Oral Maxillofac Surg)
    This study not only elucidated the potential causal relationships between TD including its two subtypes and OCPC risk, but also highlighted CXCL9 as a pivotal mediator in this association.
    Journal
    |
    CXCL9 (Chemokine (C-X-C motif) ligand 9)
    1m
    Clinical and genomic characterization of chemoradiation-resistant HPV-positive oropharyngeal squamous cell carcinoma. (PubMed, Front Oncol)
    These tumors demonstrate higher rates of p53 mutation and activation of MYC, SRC, and TGF-beta pathways. A comparison of tumors before and after treatment demonstrates PI3K-EMT-Stem pathways post-treatment in HPV-positive tumors with persistent disease after platinum-based chemoradiation.
    Journal
    |
    TP53 (Tumor protein P53) • NF1 (Neurofibromin 1) • KMT2D (Lysine Methyltransferase 2D) • TGFB1 (Transforming Growth Factor Beta 1) • PIK3C2B (Phosphatidylinositol-4-Phosphate 3-Kinase Catalytic Subunit Type 2 Beta)
    |
    TP53 mutation
    1m
    Pre-operative Atezolizumab in Patients With Resectable, Human Papillomavirus Related Oropharyngeal Carcinoma (clinicaltrials.gov)
    P2, N=20, Recruiting, Emory University | Suspended --> Recruiting | Initiation date: Feb 2024 --> Oct 2023
    Enrollment open • Trial initiation date
    |
    Tecentriq (atezolizumab)
    1m
    EGFR overexpression and macrophage infiltration correlate with poorer prognosis in HPV-negative oropharyngeal cancer via STAT6 signaling. (PubMed, Head Neck)
    There is strong correlation between EGFR overexpression and M2 polarization in patients with p16-negative OPC. Immunotherapy with or without EGFR inhibitor could be considered in these high-risk patients.
    Journal • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • STAT6 (Signal transducer and activator of transcription 6) • MRC1 (Mannose Receptor C-Type 1)
    |
    EGFR overexpression • EGFR positive • CDKN2A negative • MRC1 expression
    1m
    Ex Vivo 3D-ultrasound for Oropharyngeal Cancer (clinicaltrials.gov)
    P=N/A, N=15, Completed, Rigshospitalet, Denmark
    New trial • Surgery
    1m
    SPOT-US: Surgeon-performed Outpatient Transoral and Transcervical Ultrasound of the Oropharynx (clinicaltrials.gov)
    P=N/A, N=112, Recruiting, Rigshospitalet, Denmark | Trial primary completion date: Feb 2024 --> Sep 2024
    Trial primary completion date
    1m
    GCO 16-0609: Quarterback 2b - Sequential Therapy With Reduced Dose Chemoradiotherapy for HPV Oropharynx Cancer (clinicaltrials.gov)
    P=N/A, N=43, Active, not recruiting, Icahn School of Medicine at Mount Sinai | Phase classification: P2 --> P=N/A
    Phase classification • Metastases
    1m
    Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic Surgery (clinicaltrials.gov)
    P=N/A, N=60, Recruiting, CMR Surgical Ltd | Not yet recruiting --> Recruiting
    Enrollment open • Surgery
    1m
    Could MMP3 and MMP9 Serve as Biomarkers in EBV-Related Oropharyngeal Cancer. (PubMed, Int J Mol Sci)
    The obtained results confirm the diagnostic accuracy for MMP 3 and MMP 9. Both MMPs may be useful in the diagnosis of EBV positive OPSCC patients.
    Journal
    |
    MMP9 (Matrix metallopeptidase 9) • MMP3 (Matrix metallopeptidase 3)
    1m
    Testing the Addition of an Investigational Drug, Xevinapant, to Usual Radiation Therapy Plus Cisplatin/Carboplatin for Patients With Head and Neck Cancer (clinicaltrials.gov)
    P2, N=180, Not yet recruiting, ECOG-ACRIN Cancer Research Group | Initiation date: Jan 2024 --> Apr 2024
    Trial initiation date
    |
    TNFA (Tumor Necrosis Factor-Alpha)
    |
    CDKN2A negative
    |
    cisplatin • carboplatin • xevinapant (Debio 1143)
    1m
    A Study Evaluating Efficacy and Safety of Multiple Treatment Combinations in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (Morpheus-Head and Neck Cancer) (clinicaltrials.gov)
    P1/2, N=90, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting | Trial completion date: Aug 2027 --> Aug 2024 | Trial primary completion date: Nov 2026 --> Aug 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    PD-L1 expression
    |
    Tecentriq (atezolizumab) • carboplatin • paclitaxel • tiragolumab (RG6058)
    1m
    ROMA LA-OPSCC2: Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma 2 (clinicaltrials.gov)
    P=N/A, N=30, Active, not recruiting, University Health Network, Toronto | Trial completion date: Aug 2024 --> Mar 2025 | Trial primary completion date: Dec 2023 --> Jan 2025
    Trial completion date • Trial primary completion date • Metastases
    1m
    Testing the Addition of M6620 (VX-970, Berzosertib) to Usual Chemotherapy and Radiation for Head and Neck Cancer (clinicaltrials.gov)
    P1, N=43, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Mar 2025
    Trial completion date • Combination therapy • Metastases
    |
    cisplatin • berzosertib (M6620)
    1m
    18P.389: Durvalumab With or Without Metformin in Treating Participants With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P1, N=38, Completed, Sidney Kimmel Cancer Center at Thomas Jefferson University | Active, not recruiting --> Completed
    Trial completion
    |
    Imfinzi (durvalumab) • metformin
    1m
    Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer (clinicaltrials.gov)
    P2, N=90, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Sep 2024 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • MRI