^
    2years
    Study of Intratumoral (IT) Ulevostinag (MK-1454) in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (MK-1454-002) (clinicaltrials.gov)
    P2, N=18, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed | N=200 --> 18 | Trial completion date: Apr 2023 --> Sep 2022 | Trial primary completion date: Apr 2023 --> Sep 2022
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • ulevostinag (MK-1454)
    over2years
    Study of Ulevostinag (MK-1454) Alone or in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors or Lymphomas (MK-1454-001) (clinicaltrials.gov)
    P1, N=157, Completed, Merck Sharp & Dohme Corp. | Active, not recruiting --> Completed | N=235 --> 157
    Trial completion • Enrollment change • Combination therapy
    |
    CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • ulevostinag (MK-1454)
    over2years
    Study of Ulevostinag (MK-1454) Alone or in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors or Lymphomas (MK-1454-001) (clinicaltrials.gov)
    P1, N=235, Active, not recruiting, Merck Sharp & Dohme Corp. | Trial completion date: Oct 2022 --> Apr 2022 | Trial primary completion date: Oct 2022 --> Apr 2022
    Trial completion date • Trial primary completion date • Combination therapy
    |
    CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • ulevostinag (MK-1454)
    over3years
    Current status of intralesional agents in treatment of malignant melanoma. (PubMed, Ann Transl Med)
    This review focuses on the current status of IT agents currently under clinical trials in melanoma. Reviewed therapies include T-VEC, T-VEC with immune checkpoint inhibitors including ipilimumab and pembrolizumab or other agents, RP1, OrienX010, Canerpaturev (C-REV, HF10), CAVATAK (coxsackievirus A21, CVA21) alone or in combination with checkpoint inhibitors, oncolytic polio/rhinovirus recombinant (PVSRIPO), MAGE-A3-expressing MG1 Maraba virus, VSV-IFNbetaTYRP1, suicide gene therapy, ONCOS-102, OBP-301 (Telomelysin), Stimulation of Interferon Genes Pathway (STING agonists) including DMXAA, MIW815 (ADU-S100) and MK-1454, PV-10, toll-like receptors (TLRs) agonists including TLR-9 agonists (SD-101, CMP-001, IMO-2125 or tilsotolimod, AST-008 or cavrotolimod, MGN1703 or lefitolimod), CV8102, NKTR-262 plus NKTR-214, LHC165, G100, intralesional interleukin-2, Daromun (L19IL2 plus L19TNF), Hiltonol (poly-ICLC), electroporation including calcium electroporation and plasmid interleukin-12 electroporation (pIL-12 EP), IT ipilimumab, INT230-6 (cisplatin and vinblastine with an amphiphilic penetration enhancer), TTI-621 (SIRPαFc), CD-40 agonistic antibodies (ABBV-927 and APX005M), antimicrobial peptide LL37 and other miscellaneous agents.
    Review • Journal
    |
    TYRP1 (Tyrosinase Related Protein 1) • CD40 (CD40 Molecule) • MAGEA3 (MAGE Family Member A3)
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab) • Imlygic (talimogene laherparepvec) • bempegaldesleukin (NKTR-214) • vidutolimod (CMP-001) • Fibromun (onfekafusp alfa) • ONCOS-102 • cavrotolimod (AST-008) • cisplatin/vinblastine/SHAO-FA (INT230-6) • nelitolimod (SD-101) • ADU-S100 • CV8102 • Cavatak (gebasaxturev) • Hiltonol (poly-ICLC) • LHC165 • NKTR-262 • Nidlegy (darleukin/fibromun) • OrienX010 • Telomelysin (suratadenoturev) • canerpaturev (TBI-1401) • giloralimab (ABBV-927) • lefitolimod (MGN1703) • sotigalimab (PYX-107) • tilsotolimod (IMO-2125) • ulevostinag (MK-1454)
    over3years
    Study of Intratumoral (IT) MK-1454 in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (MK-1454-002) (clinicaltrials.gov)
    P2, N=200, Active, not recruiting, Merck Sharp & Dohme Corp. | Trial completion date: Sep 2023 --> Apr 2023 | Trial primary completion date: Sep 2023 --> Apr 2023
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • ulevostinag (MK-1454)
    over3years
    Study of MK-1454 Alone or in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors or Lymphomas (MK-1454-001) (clinicaltrials.gov)
    P1, N=235, Active, not recruiting, Merck Sharp & Dohme Corp. | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed • Combination therapy
    |
    CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • ulevostinag (MK-1454)
    over3years
    Study of Intratumoral (IT) MK-1454 in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (MK-1454-002) (clinicaltrials.gov)
    P2, N=200, Active, not recruiting, Merck Sharp & Dohme Corp. | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • ulevostinag (MK-1454)
    over4years
    [VIRTUAL] Phase II study of intratumoral MK-1454 plus pembrolizumab compared with pembrolizumab monotherapy as first-line treatment for metastatic or unresectable, recurrent head and neck squamous cell carcinoma (ESMO 2020)
    In KEYNOTE-048, which compared pembro ± chemotherapy with cetuximab + chemotherapy in patients with previously untreated metastatic or recurrent head and neck squamous cell carcinoma (HNSCC), pembro significantly prolonged OS as monotherapy in patients with a PD-L1 combined positive score (CPS) ≥1 and ≥20 and in combination with chemotherapy in patients with CPS ≥1 and ≥20 and in the total population. Funding: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Clinical trial identification: 2019-003060-42; NCT04220866.
    Clinical • P2 data
    |
    STING (stimulator of interferon response cGAMP interactor 1)
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • ulevostinag (MK-1454)
    over4years
    [VIRTUAL] Characterization of STING pathway agonists using in vitro phenotypic assay models (AACR-II 2020)
    A phase I clinical trial with a STING agonist (MK-1454) is currently underway in patients with advanced metastatic solid tumors or lymphomas...The effect on proliferation, apoptosis, and cell viability will be discussed. Tumor microenvironment models will also be treated with compounds and screened for validated biomarkers.
    Preclinical • IO biomarker
    |
    CD8 (cluster of differentiation 8) • STING (stimulator of interferon response cGAMP interactor 1)
    |
    ulevostinag (MK-1454)
    over4years
    Study of Intratumoral (IT) MK-1454 in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (MK-1454-002) (clinicaltrials.gov)
    P2, N=200, Recruiting, Merck Sharp & Dohme Corp. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • ulevostinag (MK-1454)
    over4years
    Phase 2 Study in 1L HNSCC of IT MK-1454 / MK-3475 IV vs MK-3475 IV Estudio de fase 2 en CECC en 1L de MK-1454 IT/MK-3475 IV frente a MK-3475 IV. (clinicaltrialsregister.eu)
    P2, N=200, Ongoing, Merck Sharp & Dohme Corp., a subsidiary of Merck &Co.,Inc
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • ulevostinag (MK-1454)