Hiltonol (poly-ICLC) / Oncovir  >>  Phase 1
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31 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Hiltonol (poly-ICLC) / Oncovir
NCT03223103: Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma

Active, not recruiting
1
13
US
Poly-ICLC, Hiltonol®, Tumor Treating Fields, Optune®, Peptides, Personalized peptides
Albert Einstein College of Medicine, NovoCure Ltd.
Glioblastoma
07/20
05/25
NCT03121677: Personalized Tumor Vaccine Strategy and PD-1 Blockade in Patients With Follicular Lymphoma

Terminated
1
4
US
Personalized tumor vaccine, Poly ICLC, poly-ICLC, Nivolumab, Opdivo, Peripheral blood draws, Leukapheresis, Rituximab, Rituxan, Biopsy
Washington University School of Medicine
Follicular Lymphoma
09/20
08/23
NCT04345705: Direct Injection of Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma

Not yet recruiting
1
18
US
Poly ICLC, Hiltonol®
Raja M Flores, Oncovir, Inc.
Mesothelioma
05/22
05/22
NCT03956056: Neoantigen Peptide Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy

Terminated
1
12
US
Neoantigen Peptide Vaccine, Poly ICLC, Poly-ICLC, Hiltonol, Blood for immune monitoring
Washington University School of Medicine, National Institutes of Health (NIH), National Cancer Institute (NCI)
Pancreas Cancer, Pancreatic Cancer, Cancer of the Pancreas
07/22
07/23
NCT02549833: Neo-adjuvant Evaluation of Glioma Lysate Vaccines in WHO Grade II Glioma

Active, not recruiting
1
28
US
GBM6-AD and poly-ICLC before and after surgery, GBM6-AD and poly-ICLC after surgery only
Jennie Taylor, University of Minnesota
Oligodendroglioma, Astrocytoma, Grade II, Glioma, Astrocytic, Glioma, Malignant Glioma, Oligoastrocytoma, Mixed
08/22
08/24
NCT02924038: A Study of Varlilumab and IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG)

Terminated
1
14
US
IMA950, IMA950 peptides, poly-ICLC, Hiltonol, Varlilumab, CDX-1127
Nicholas Butowski, Celldex Therapeutics, National Cancer Institute (NCI)
Glioma, Malignant Glioma, Astrocytoma, Grade II, Oligodendroglioma, Glioma, Astrocytic, Oligoastrocytoma, Mixed
12/22
12/22
NCT04672291: Nasal Poly-ICLC (Hiltonol®) in Healthy COVID-19 Vaccinated Adults

Completed
1
43
Canada
Poly-ICLC (Hiltonol®) or Placebo, Safety, Expansion
Oncovir, Inc., University of Calgary
COVID - 19
04/23
04/23
NCT04799431: Neoantigen-Targeted Vaccine Combined With Anti-PD-1 Antibody for Patients With Stage IV MMR-p Colon and Pancreatic Ductal Cancer

Withdrawn
1
12
NA
Neoantigen Vaccine with Poly-ICLC adjuvant, Hiltonol® (Poly-ICLC), Retifanlimab, INCMGA00012; MGA012
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Incyte Corporation, National Cancer Institute (NCI)
Pancreatic Cancer Metastatic, Colorectal Cancer Metastatic
05/23
05/23
NCT02826434: Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer

Active, not recruiting
1
22
US
PVX-410, Durvalumab, MEDI4736, Hiltonol, poly-ICLC
Massachusetts General Hospital, OncoPep, Inc., AstraZeneca
Breast Cancer
06/25
09/26
NCT02886065: A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM

Active, not recruiting
1
19
US
Hiltonol, Poly ICLC, Citarinostat, CC-96241, Lenalidomide, REVLIMID, PVX-410
Massachusetts General Hospital, Celgene, OncoPep, Inc.
Smoldering Multiple Myeloma
09/24
09/24
NCT04525859: Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma

Recruiting
1
19
US
Safety, Expansion Cohort
Oncovir, Inc., Icahn School of Medicine at Mount Sinai
Malignant Pleural Mesothelioma
08/23
08/24
NCT05025488: Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm

Recruiting
1
10
US
Peptide-based vaccine, Poly ICLC
Marina Kremyanskaya
Myelofibrosis, Essential Thrombocythemia, MPN
03/26
03/26
AM-003, NCT04116320: Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors

Active, not recruiting
1
5
US
Echopulse, Focused Ultrasound Ablation, FUSA, Poly ICLC, Hiltonol, Standard of Care PD-1 Therapy
Craig L Slingluff, Jr, Theraclion
Melanoma, Breast Cancer, Merkel Cell Carcinoma, Squamous Cell Cancer, Non Small Cell Lung Cancer, Cervical Cancer, Urothelial Carcinoma, Ovarian Cancer, Hepatocellular Carcinoma, Small-cell Lung Cancer, Microsatellite Instability High, Gastric Cancer, Esophageal Cancer
02/24
02/24
NCT06218303: Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ

Recruiting
1
50
US
MUC1 Peptide Vaccine, Hiltonol®, POLY-ICLC, Aromatase Inhibitor, Anastrozole (Arimidex), Letrozole (Femara), Exemestane (Aromasin)
Finn, Olivera, PhD, A Glimmer of Hope Foundation, Breast Cancer Research Foundation
Ductal Carcinoma in Situ
01/26
08/28
NCT05557240: Neoantigens Phase I Trial in Newly Diagnosed Glioblastoma Patients

Recruiting
1
10
RoW
NeoPep Vaccine1 plus Poly-ICLC, NPVAC1+Poly-ICLC, NeoPep Vaccine2 plus Poly-ICLC, NPVAC2+Poly-ICLC
Shanghai 10th People's Hospital, Hangzhou NeoVax Biotechnology Co. LTD
Glioma, Malignant, Antigen-specific Vaccines, Individualized Treatment
02/24
08/25
NCT05281926: A Phase I, Open-label Study to Assess the Safety and Efficacy of Poly-ICLC Plus Nivolumab in Unresectable Hepatocellular Carcinoma Patients

Recruiting
1
10
RoW
Poly ICLC, Nivolumab
National Taiwan University Hospital
Hepatocellular Carcinoma
06/24
09/24
NCT04201873: Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma

Recruiting
1
40
US
Dendritic Cell Tumor Cell Lysate Vaccine, DC tumor cell lysate vaccine, dendritic cell-pulsed tumor cell lysate vaccine, Pembrolizumab, Keytruda, Lambrolizumab, MK-3475, SCH 900475, Placebo Administration, Poly ICLC, Hiltonol, Poly I:Poly C with Poly-L-Lysine Stabilizer, poly-ICLC, PolyI:PolyC with Poly-L-Lysine Stabilizer, Polyinosinic-Polycytidylic Acid Stabilized with Polylysine and Carboxymethylcellulose, Polyriboinosinic-Polyribocytidylic Acid-Polylysine Carboxymethylcellulose, Stabilized Polyriboinosinic/Polyribocytidylic Acid
Jonsson Comprehensive Cancer Center, National Cancer Institute (NCI), Merck Sharp & Dohme LLC, Phase One Foundation, Oncovir, Inc.
Recurrent Glioblastoma
12/24
12/25
Mel 70, NCT06472661: FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma

Recruiting
1
11
US
Echopulse or Echopulse HD, Focused Ultrasound Ablation, FUSA, PolyICLC, Hiltinol
University of Virginia, Theraclion
Advanced Melanoma
08/26
08/26
NCT05098210: Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma or Hormone Receptor Positive Her2 Negative Metastatic Refractory Breast Cancer

Recruiting
1
20
US
Neoantigen Peptide Vaccine, Nivolumab, BMS-936558, CMAB819, MDX-1106, NIVO, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo, Poly ICLC, Hiltonol, Poly I:Poly C with Poly-L-Lysine Stabilizer, poly-ICLC, PolyI:PolyC with Poly-L-Lysine Stabilizer, Polyinosinic-Polycytidylic Acid Stabilized with Polylysine and Carboxymethylcellulose, Polyriboinosinic-Polyribocytidylic Acid-Polylysine Carboxymethylcellulose, Stabilized Polyriboinosinic/Polyribocytidylic Acid
Fred Hutchinson Cancer Center, Amazon.com Services LLC
Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Hormone Receptor-Positive Breast Carcinoma, Locally Advanced Cutaneous Melanoma, Metastatic Acral Lentiginous Melanoma, Metastatic Conjunctival Melanoma, Metastatic Cutaneous Melanoma, Metastatic HER2-Negative Breast Carcinoma, Metastatic Mucosal Melanoma, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Prognostic Stage IV Breast Cancer AJCC v8, Recurrent Acral Lentiginous Melanoma, Recurrent Cutaneous Melanoma, Recurrent Mucosal Melanoma, Refractory HER2-Negative Breast Carcinoma, Unresectable Acral Lentiginous Melanoma, Unresectable Cutaneous Melanoma, Unresectable Mucosal Melanoma
11/25
11/26
NCT06564623: Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC)

Not yet recruiting
1
25
US
mBTC vax [0.3 - 2.4 mg peptide + 0.5 mg Poly-ICLC (Hiltonol)], Peptide + Poly-ICLC (Hiltonol), Durvalumab, IMFINZI®, Tremelimumab, IMJUDO®
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, AstraZeneca, Private Philanthropic Funds
Pancreatic Cancer
11/28
11/28
NCT06529822: Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease

Not yet recruiting
1
16
US
Synthetic long peptide personalized cancer vaccine, PCV, Poly ICLC, Hiltonol, Nivolumab, Signatera assay
Washington University School of Medicine, Natera, Inc.
Muscle-Invasive Bladder Carcinoma
06/28
05/33
IRB00210915, NCT04117087: Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Resected Mismatch Repair Protein (MMR-p) Colorectal and Pancreatic Cancer

Recruiting
1
30
US
KRAS peptide vaccine, Hiltonol® (Poly-ICLC), Nivolumab, OPDIVO, Ipilimumab, YERVOY®
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Bristol-Myers Squibb, National Cancer Institute (NCI), National Institutes of Health (NIH)
Colorectal Cancer, Pancreatic Cancer
08/25
08/25
NCT06342908: A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma

Not yet recruiting
1
6
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Dendritic Cell Therapy, Dendritic Cell Vaccine Therapy, Leukapheresis, Leukocytopheresis, Therapeutic Leukopheresis, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Poly ICLC, Hiltonol, Poly I:Poly C with Poly-L-Lysine Stabilizer, poly-ICLC, PolyI:PolyC with Poly-L-Lysine Stabilizer, Polyinosinic-Polycytidylic Acid Stabilized with Polylysine and Carboxymethylcellulose, Polyriboinosinic-Polyribocytidylic Acid-Polylysine Carboxymethylcellulose, Stabilized Polyriboinosinic/Polyribocytidylic Acid
Jonsson Comprehensive Cancer Center
Diffuse Hemispheric Glioma, H3 G34-Mutant
03/27
01/28
NCT01130077: A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction With Poly-ICLC in Pediatric Gliomas

Active, not recruiting
1
60
US
HLA-A2 restricted glioma antigen peptides vaccine, BB13624, Poly-ICLC
James Felker, Ellie Kavalieros Fund, Translational Brain Tumor Research Fund, Connor's Cure
Newly Diagnosed Pediatric Pontine Glioma, Newly Diagnosed Pediatric High Grade Glioma, Recurrent Pediatric High Grade Glioma, Recurrent Pediatric Low Grade Glioma
12/24
12/25
1B-22-2, NCT04616248: In Situ Immunomodulation With CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients w/ Unresectable and Metastatic Solid Tumors

Recruiting
1
18
US
Anti-CD40 Agonist Monoclonal Antibody CDX-1140, Agonist CD40 Antibody CDX-1140, Anti-CD40 Agonistic Monoclonal Antibody CDX-1140, CDX 1140, CDX-1140, Poly ICLC, Hiltonol, Poly I:Poly C with Poly-L-Lysine Stabilizer, poly-ICLC, PolyI:PolyC with Poly-L-Lysine Stabilizer, Polyinosinic-Polycytidylic Acid Stabilized with Polylysine and Carboxymethylcellulose, Polyriboinosinic-Polyribocytidylic Acid-Polylysine Carboxymethylcellulose, Stabilized Polyriboinosinic/Polyribocytidylic Acid, Radiation Therapy, Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation, Recombinant Flt3 Ligand, CDX-301, FLT 3 Ligand, FLT3 Ligand, Flt3-Ligand, Flt3L, Mobist, Mobista, rhuFlt3L, Pembrolizumab, Keytruda, Tocilizumab, Actemra
University of Southern California
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8, Unresectable Breast Carcinoma, Metastatic Melanoma, Unresectable Melanoma, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma, Soft Tissue Sarcoma, Bone Sarcoma, Sarcoma,Soft Tissue, Sarcoma of Bone, Basal Cell Carcinoma
01/25
01/26
ETAPA I, NCT05283109: Peptide-based Tumor Associated Antigen Vaccine in GBM

Recruiting
1
36
US
Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine, P30-EPS, Hiltonol, poly-ICLC
Mustafa Khasraw, MBChB, MD, FRCP, FRACP, National Cancer Institute (NCI)
Glioma, Malignant
04/25
02/28
NCT05111353: Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery

Recruiting
1
30
US
Optimized neoantigen synthetic long peptide vaccine, Poly-ICLC, Hiltonol
Washington University School of Medicine, National Cancer Institute (NCI), Leidos, UNICO Foundation
Pancreas Cancer, Pancreatic Cancer, Cancer of the Pancreas
12/25
12/27
NCT05013216: Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer

Recruiting
1
37
US
Cohort A: Patients at high risk of developing pancreatic cancer., Hiltonol® (Poly-ICLC), Cohort B: Patients must have evidence of a pancreatic cystic neoplasm
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Stand Up To Cancer
High Risk Cancer, Pancreatic Cancer
05/26
05/26
PGV-Prostate, NCT05010200: The Safety and Tolerability of PGV001-based Personalized Multi-peptide Vaccines in the Adjuvant Setting.

Recruiting
1
27
US
PGV-001, Poly-ICLC, CDX-301
Ashutosh Kumar Tewari
Prostate Cancer
01/27
01/28
NCT04248569: DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Fibrolamellar Hepatocellular Carcinoma

Recruiting
1
56
US
DNAJB1-PRKACA peptide vaccine, Hiltonol® (Poly-ICLC), Nivolumab, OPDIVO, Ipilimumab, YERVOY®
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Bristol-Myers Squibb, Fibrolamellar Cancer Foundation, National Cancer Institute (NCI)
Fibrolamellar Hepatocellular Carcinoma (FLC)
03/27
03/27
NCT05457959: Peptide-Pulsed Dendritic Cell Vaccination in Combination With Nivolumab and Ipilimumab for the Treatment of Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-mutant

Not yet recruiting
1
15
US
Dendritic Cell Tumor Peptide Vaccine, DC tumor peptide vaccine, dendritic cells pulsed with tumor peptide, Ipilimumab, Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, Ipilimumab Biosimilar CS1002, MDX-010, MDX-CTLA4, Yervoy, Leukapheresis, Leukocytopheresis, Therapeutic Leukopheresis, Nivolumab, BMS-936558, CMAB819, MDX-1106, NIVO, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo, Placebo Administration, Poly ICLC, Hiltonol, Poly I:Poly C with Poly-L-Lysine Stabilizer, poly-ICLC, PolyI:PolyC with Poly-L-Lysine Stabilizer, Polyinosinic-Polycytidylic Acid Stabilized with Polylysine and Carboxymethylcellulose, Polyriboinosinic-Polyribocytidylic Acid-Polylysine Carboxymethylcellulose, Stabilized Polyriboinosinic/Polyribocytidylic Acid, Resection, Surgical Resection
Jonsson Comprehensive Cancer Center
Diffuse Hemispheric Glioma, H3 G34-Mutant
12/29
05/30

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