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    DRUG CLASS:

    HPV-16 E6 protein inhibitor

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    Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies (NCT04287868)
    Phase 1/2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/19/2025
    Initiation :
    06/09/2020
    Primary completion :
    07/26/2022
    Completion :
    07/01/2026
    PD-L1 • CDKN2A • CD4
    |
    PD-L1 negative
    |
    bintrafusp alfa (M7824) • Versamune HPV • PDS01ADC
    A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1 (AHEAD-MERIT) (NCT04534205)
    Phase 2
    BioNTech SE
    Recruiting
    Last update posted :
    01/28/2025
    Initiation :
    01/07/2021
    Primary completion :
    05/01/2028
    Completion :
    05/01/2028
    PD-L1
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • BNT113
    Study of PDS0101 and Pembrolizumab Combination I/O in Subjects with HPV16 + Recurrent And/or Metastatic HNSCC (VERSATILE-002) (NCT04260126)
    Phase 2
    PDS Biotechnology Corp.
    Active, not recruiting
    Last update posted :
    12/18/2024
    Initiation :
    03/29/2021
    Primary completion :
    06/01/2025
    Completion :
    06/01/2025
    PD-L1
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • Versamune HPV
    A Vaccine (PDS0101) and Chemoradiation for the Treatment of Stage IB3-IVA Cervical Cancer, the IMMUNOCERV Trial (NCT04580771)
    Phase 2
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    06/04/2024
    Initiation :
    10/14/2020
    Primary completion :
    03/08/2025
    Completion :
    03/08/2025
    ALK
    |
    cisplatin • Versamune HPV
    Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R/R HPV-related Oropharyngeal Cancers (NCT05582590)
    Phase 1
    NexImmune Inc.
    Not yet recruiting
    Last update posted :
    01/15/2024
    Initiation :
    03/31/2025
    Primary completion :
    07/01/2026
    Completion :
    08/25/2027
    HLA-A
    |
    cyclophosphamide • fludarabine IV • NEXI-003
    A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC (OpcemISA) (NCT03669718)
    Phase 2
    ISA Pharmaceuticals
    Active, not recruiting
    Last update posted :
    12/29/2023
    Initiation :
    11/30/2018
    Primary completion :
    09/01/2024
    Completion :
    06/01/2025
    PD-L1
    |
    PD-L1 expression
    |
    Libtayo (cemiplimab-rwlc) • ISA101
    VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Related Anal or Anal/Peri-Anal, High Grade Squamous Intraepithelial Lesion (HSIL) in Individuals Seronegative for Human Immunodeficiency Virus (HIV)-1/2 (NCT03499795)
    Phase 2
    Inovio Pharmaceuticals
    Completed
    Last update posted :
    07/14/2023
    Initiation :
    05/15/2018
    Primary completion :
    06/16/2020
    Completion :
    05/26/2021
    CD8 • TNFRSF9
    |
    CD8 positive
    |
    bizalimogene ralaplasmid (VGX-3100)
    CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers (NCT05122221)
    Phase 1
    Corregene Biotechnology Co., Ltd
    Recruiting
    Last update posted :
    06/28/2022
    Initiation :
    07/17/2022
    Primary completion :
    03/01/2023
    Completion :
    12/01/2024
    HLA-A
    |
    HLA-A*02
    |
    cyclophosphamide • fludarabine IV • CRTE7A2-01 • cyclophosphamide intravenous
    DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (NCT03439085)
    Phase 2
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    02/14/2022
    Initiation :
    11/14/2018
    Primary completion :
    12/31/2022
    Completion :
    12/31/2022
    CD4
    |
    Imfinzi (durvalumab) • rocakinogene sifuplasmid (INO-9012) • MEDI0457
    A Study of INO-3112 DNA Vaccine With Electroporation in Participants With Cervical Cancer (NCT02172911)
    Phase 1/2
    Inovio Pharmaceuticals
    Completed
    Last update posted :
    02/21/2021
    Initiation :
    06/06/2014
    Primary completion :
    09/07/2017
    Completion :
    09/07/2017
    IFNG
    |
    MEDI0457
    Study of HPV Specific Immunotherapy in Participants With HPV Associated Head and Neck Squamous Cell Carcinoma (NCT02163057)
    Phase 1/2
    Inovio Pharmaceuticals
    Completed
    Last update posted :
    01/22/2021
    Initiation :
    08/13/2014
    Primary completion :
    01/23/2017
    Completion :
    01/23/2017
    CD8 • CD69 • TNFRSF9 • GZMB • FOXP3 • GZMA • PRF1
    |
    TILs
    |
    MEDI0457