^
    23h
    KEYNOTE A99: Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) (clinicaltrials.gov)
    P1/2, N=296, Active, not recruiting, Inhibrx Biosciences, Inc | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden)
    |
    EGFR mutation • TMB-H • MSI-H/dMMR • ALK rearrangement
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • ordastobart (INBRX-106)
    1d
    Spark2: Neoadjuvant Targeting of Myeloid Cell Populations in Combination With Nivolumab in Head & Neck Ca (clinicaltrials.gov)
    P2, N=24, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Opdivo (nivolumab) • BMS-986253
    1d
    Multi-omics profiling of ACOX3 unveils pan-cancer clinical biomarker potential. (PubMed, Comput Biol Chem)
    ACOX3 represents a dual diagnostic and prognostic biomarker with broad pan-cancer relevance, exhibiting distinct immune correlates and therapeutic potential.
    Journal • Pan tumor
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    AZD6482 • TGX-221
    2d
    Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=44, Completed, Bristol-Myers Squibb | Terminated --> Completed
    Trial completion
    |
    Opdivo (nivolumab) • Erbitux (cetuximab)
    2d
    Genomic landscape of a long-term surviving patient with metastatic cancer of the larynx: a case report. (PubMed, Front Oncol)
    Our findings suggest that subtle regulatory variants may contribute to favorable clinical outcomes in rare long-term survivors of R/M HNSCC. Further studies are needed to identify predictive biomarkers in this unique subgroup of patients.
    Journal
    |
    EIF4EBP1 (Eukaryotic translation initiation factor 4E binding protein 1) • CTBP2 (C-Terminal Binding Protein 2)
    2d
    cGAS-STING pathway reprograms macrophage polarization and is highly expressed in responding tumors after neoadjuvant immunotherapy in head and neck carcinoma. (PubMed, Acta Biochim Biophys Sin (Shanghai))
    In support of translational relevance, analysis of single-cell RNA-seq data from HNSCC patients receiving neoadjuvant immunotherapy indicates that TMEM173 is expressed primarily in T cells and macrophages and that the cGAS-STING pathway score is significantly higher in patients who respond to treatment. Collectively, these findings provide systematic clinical and experimental evidence supporting the potential of STING agonists, such as MSA-2, to enhance antitumor immunity in HNSCC, particularly when combined with immunotherapy.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CD68 (CD68 Molecule) • IFNA1 (Interferon Alpha 1) • CD80 (CD80 Molecule) • IFNB1 (Interferon Beta 1)
    2d
    Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma (MINK). A "Window of Opportunity" Pilot Study. (clinicaltrials.gov)
    P4, N=25, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    2d
    Paclitaxel, Carboplatin and Cetuximab (PCC) With Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=128, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    Erbitux (cetuximab) • cisplatin • carboplatin • paclitaxel • docetaxel • fluorouracil topical
    2d
    NRG-HN008: Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin (clinicaltrials.gov)
    P1, N=21, Active, not recruiting, National Cancer Institute (NCI) | N=42 --> 21 | Trial completion date: Dec 2025 --> Dec 2026
    Enrollment change • Trial completion date
    |
    CD4 (CD4 Molecule)
    |
    peposertib (M3814)
    2d
    NCI-2018-01836: Sorafenib in Combination With Carboplatin and Paclitaxel in Treating Participants With Metastatic or Recurrent Head and Neck Squamous Cell Cancer (clinicaltrials.gov)
    P2, N=48, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    carboplatin • sorafenib • paclitaxel
    2d
    Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer (clinicaltrials.gov)
    P2, N=90, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    3d
    A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    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
    Trial completion date • Trial initiation date • Trial primary completion date • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)