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Therapy Name Poly ICLC
Synonyms
Therapy Description

Hiltonol (poly ICLC) is a synthetic double stranded RNA complex, which induces interferon production and stimulates anti-tumor immune response (PMID: 22126373).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Poly ICLC Hiltonol Hiltonol (poly ICLC) is a synthetic double stranded RNA complex, which induces interferon production and stimulates anti-tumor immune response (PMID: 22126373).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02425306 Phase Ib/II Cyclophosphamide 6MHP vaccine Poly ICLC Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma Terminated USA 0
NCT06064279 Phase Ib/II Poly ICLC Harnessing Allo-immunity to Enhance Immune Checkpoint Inhibitor Responses in Advanced NSCLC (HAITEN-ICI) Withdrawn USA 0
NCT02427581 Phase I Poly ICLC Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy Withdrawn 0
NCT03262103 Phase I Poly ICLC Neoadjuvant Hiltonol (PolyICLC) for Prostate Cancer Completed USA 0
NCT01532960 Phase I Poly ICLC Pilot Study of a Breast Cancer Vaccine Plus Poly-ICLC for Breast Cancer (Breast 41) Terminated USA 0
NCT02166905 Phase Ib/II Poly ICLC Rasdegafusp alfa Epacadostat DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission Completed USA 0
NCT02413827 Phase Ib/II Nivolumab + Varlilumab Rasdegafusp alfa Poly ICLC A Study of Varlilumab (Anti-CD27) and Ipilimumab and CDX-1401 in Patients With Unresectable Stage III or IV Melanoma Terminated USA 0
NCT04525859 Phase I Poly ICLC Poly-ICLC (Hiltonol) Vaccine In Malignant Pleural Mesothelioma Unknown status USA 0
NCT02126579 Phase Ib/II Poly ICLC Long peptide vaccine 7 Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists Completed USA 0
NCT04544007 Phase II Poly ICLC A Phase II Trial of Poly-ICLC for Low-Grade Gliomas (NF111) Terminated USA 0
NCT02332889 Phase Ib/II Decitabine Poly ICLC Phase I/II Decitabine/Vaccine Therapy in Relapsed/Refractory Pediatric High Grade Gliomas/Medulloblastomas/CNS PNETs Terminated USA 0
NCT03068832 Phase I Poly ICLC Neoepitope-based Personalized Vaccine Approach in Pediatric Patients With Recurrent Brain Tumors Withdrawn 0
NCT02358187 Phase II Poly ICLC A Vaccine Trial for Low Grade Gliomas Recruiting USA 0
NCT01188096 Phase II Poly ICLC A Trial of Poly-ICLC in the Management of Recurrent Pediatric Low Grade Gliomas Completed USA 0
NCT06342908 Phase I Neoantigen-targeted ppDC Poly ICLC A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma Recruiting USA 0
NCT02510950 Phase I Sargramostim Poly ICLC Temozolomide Neoepitope-based Personalized Vaccine Approach in Patients With Newly Diagnosed Glioblastoma Terminated USA 0
NCT01130077 Phase I Poly ICLC A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction With Poly-ICLC in Pediatric Gliomas Completed USA 0
NCT02334735 Phase II Poly ICLC Autologous Dendritic Cells Pulsed with MART-1 NY-ESO-1 peptide vaccine A Comparison of Matured Dendritic Cells and Montanide® in Study Subjects With High Risk of Melanoma Recurrence Completed USA 0
NCT02754362 Phase II Poly ICLC Bevacizumab A Toll-like Receptor Agonist as an Adjuvant to Tumor Associated Antigens (TAA) Mixed With Montanide ISA-51 VG With Bevacizumab for Patients With Recurrent Glioblastoma Withdrawn USA 0
NCT02078648 Phase Ib/II SL-701 Poly ICLC Bevacizumab Safety and Efficacy Study of SL-701, a Glioma-Associated Antigen Vaccine To Treat Recurrent Glioblastoma Multiforme Completed USA 0
NCT02423863 Phase II Poly ICLC In Situ, Autologous Therapeutic Vaccination Against Solid Cancers With Intratumoral Hiltonol Completed USA 0


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