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Showing 1–24 of 29 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Hiltonol® Clear all
Completed Phase 1 Interventional

PDE5 Inhibition Via Tadalafil to Enhance Anti-Tumor Mucin 1 (MUC1) Vaccine Efficacy in Patients With HNSCC

NCT02544880
View directory record Official record
Conditions
Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer
Interventions
Tadalafil, Anti-MUC1 Vaccine, Anti-Influenza Vaccine, Tadalafil Placebo, Anti-MUC1 Vaccine Placebo, Standard of Care Treatment, Anti-Influenza Vaccine Placebo
Drug · Biological · Other
Lead sponsor
Donald T. Weed, MD, FACS
Other
Eligibility
18 Years and older
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2021
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Jun 14, 2021 · Synced Sep 11, 2026, 9:32 PM EDT
Recruiting Phase 2 Interventional

Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance

NCT06343077
View directory record Official record
Conditions
Prostate Cancer Patients on Active Surveillance
Interventions
Poly-ICLC intramuscular (IM) injection, Poly-ICLC, Intertumoral (IT) injection
Drug
Lead sponsor
Ashutosh Kumar Tewari
Other
Eligibility
18 Years and older · Male only
Enrollment
114 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Apr 1, 2024 · Synced Sep 11, 2026, 9:32 PM EDT
Completed Phase 1 Interventional

Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma

NCT04525859
View directory record Official record
Conditions
Malignant Pleural Mesothelioma
Interventions
Safety, Expansion Cohort
Biological
Lead sponsor
Oncovir, Inc.
Industry
Eligibility
Not listed
Enrollment
19 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jun 23, 2025 · Synced Sep 11, 2026, 9:32 PM EDT
Recruiting Phase 1 Interventional

Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ

NCT06218303
View directory record Official record
Conditions
Ductal Carcinoma in Situ
Interventions
MUC1 Peptide Vaccine, Hiltonol®, Aromatase Inhibitor, Selective estrogen receptor modulator (SERM)
Biological · Drug
Lead sponsor
Finn, Olivera, PhD
Other
Eligibility
18 Years and older · Female only
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Aug 17, 2026 · Synced Sep 11, 2026, 9:32 PM EDT
Active, not recruiting Phase 1 Interventional

NeoVax With Nivolumab in Patients With Ovarian Cancer

NCT04024878
View directory record Official record
Conditions
Ovarian Cancer
Interventions
Nivolumab, NeoVax, Core Needle Biopsy
Drug · Biological · Procedure
Lead sponsor
Dana-Farber Cancer Institute
Other
Eligibility
18 Years and older · Female only
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2029
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jun 17, 2025 · Synced Sep 11, 2026, 9:32 PM EDT
Not yet recruiting Phase 1 Interventional

A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)

NCT07430202
View directory record Official record
Conditions
Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))
Interventions
DNAJB1-PRKACA Peptide Vaccine, DRP-104, Nivolumab, Ipilimumab
Drug
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Eligibility
12 Years and older
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Aug 24, 2026 · Synced Sep 11, 2026, 9:32 PM EDT
Completed Phase 2 Interventional

A Comparison of Matured Dendritic Cells and Montanide® in Study Subjects With High Risk of Melanoma Recurrence

NCT02334735
View directory record Official record
Conditions
Melanoma
Interventions
DC Vaccine, Montanide Vaccine, Poly-ICLC
Biological
Lead sponsor
Nina Bhardwaj
Other
Eligibility
18 Years and older
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
2
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Sep 14, 2022 · Synced Sep 11, 2026, 9:32 PM EDT
Completed Phase 1Phase 2 Interventional Results available

A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers

NCT02643303
View directory record Official record
Conditions
Head and Neck Squamous Cell Carcinoma, Breast Cancer, Sarcoma, Merkel Cell Carcinoma, Cutaneous T-Cell Lymphoma, Melanoma, Renal Cancer, Bladder Cancer, Prostate Cancer, Testicular Cancer, Solid Tumor
Interventions
Durvalumab, Tremelimumab, Poly-ICLC
Drug
Lead sponsor
Ludwig Institute for Cancer Research
Other
Eligibility
18 Years and older
Enrollment
58 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2022
U.S. locations
7
States / cities
Atlanta, Georgia • Lebanon, New Hampshire • Buffalo, New York + 4 more
Source: ClinicalTrials.gov public record
Updated Dec 1, 2022 · Synced Sep 11, 2026, 9:32 PM EDT
Active, not recruiting Phase 1 Interventional

Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma

NCT03223103
View directory record Official record
Conditions
Glioblastoma
Interventions
Poly-ICLC, Tumor Treating Fields, Peptides
Drug · Device · Biological
Lead sponsor
Adilia Hormigo
Other
Eligibility
18 Years and older
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2029
U.S. locations
1
States / cities
The Bronx, New York
Source: ClinicalTrials.gov public record
Updated Sep 9, 2025 · Synced Sep 11, 2026, 9:32 PM EDT
Completed Phase 1 Interventional

Neoadjuvant Hiltonol® (PolyICLC) for Prostate Cancer

NCT03262103
View directory record Official record
Conditions
Prostate Cancer
Interventions
Intratumoral (IT) Poly ICLC 0.5 mg, Intratumoral (IT) Poly ICLC 1.0 mg, Intramuscular (IM) Poly ICLC, Radical Prostatectomy
Biological · Procedure
Lead sponsor
Ashutosh Kumar Tewari
Other
Eligibility
18 Years and older · Male only
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Sep 9, 2022 · Synced Sep 11, 2026, 9:32 PM EDT
Recruiting Phase 1 Interventional

Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC)

NCT06564623
View directory record Official record
Conditions
Biliary Tract Cancers
Interventions
mBTC vax [0.3 - 2.4 mg peptide + 0.5 mg Poly-ICLC (Hiltonol)], Durvalumab, Tremelimumab
Drug
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Eligibility
18 Years and older
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated May 7, 2026 · Synced Sep 11, 2026, 9:32 PM EDT
Recruiting Phase 1 Interventional Accepts healthy volunteers

Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer

NCT05013216
View directory record Official record
Conditions
High Risk Cancer, Pancreatic Cancer
Interventions
Cohort A: Patients at high risk of developing pancreatic cancer., Cohort B: Patients must have evidence of a pancreatic cystic neoplasm
Drug
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Eligibility
40 Years and older
Enrollment
37 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2031
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Jun 29, 2026 · Synced Sep 11, 2026, 9:32 PM EDT
Terminated Phase 1Phase 2 Interventional

Poly-ICLC (Hiltonol) and Anti-PD1 or Anti-PD-L1

NCT03721679
View directory record Official record
Conditions
Solid Cancer
Interventions
Poly-ICLC combination treatment with aPD-1 (Nivolumab or Pembrolizumab) or aPD-L1 (Atezolizumab or Durvalumab) over 6 months
Biological
Lead sponsor
Oncovir, Inc.
Industry
Eligibility
18 Years and older
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
3
States / cities
Chevy Chase, Maryland • Easton, Maryland • New York, New York
Source: ClinicalTrials.gov public record
Updated Jan 31, 2021 · Synced Sep 11, 2026, 9:32 PM EDT
Terminated Phase 1 Interventional

The Safety and Antitumor Activity of the Combination of Oregovomab and Hiltonol in Recurrent Advanced Ovarian Cancer

NCT03162562
View directory record Official record
Conditions
Cancer of Ovary, Neoplasms, Ovarian, Ovarian Cancer Stage IV, Ovarian Cancer Recurrent, Ovarian Cancer Stage III, Ovary Cancer
Interventions
Oregovomab, Poly ICLC
Biological · Drug
Lead sponsor
CanariaBio Inc.
Industry
Eligibility
18 Years to 90 Years · Female only
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
2
States / cities
Orlando, Florida • Richmond, Virginia
Source: ClinicalTrials.gov public record
Updated Dec 21, 2020 · Synced Sep 11, 2026, 9:32 PM EDT
Active, not recruiting Phase 1 Interventional

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

NCT04117087
View directory record Official record
Conditions
Colorectal Cancer, Pancreatic Cancer
Interventions
KRAS peptide vaccine, Nivolumab, Ipilimumab
Drug
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Eligibility
18 Years and older
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Jul 26, 2026 · Synced Sep 11, 2026, 9:32 PM EDT
Recruiting Phase 1 Interventional

DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Fibrolamellar Hepatocellular Carcinoma

NCT04248569
View directory record Official record
Conditions
Fibrolamellar Hepatocellular Carcinoma (FLC)
Interventions
DNAJB1-PRKACA peptide vaccine, Nivolumab, Ipilimumab
Drug
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Eligibility
12 Years and older
Enrollment
56 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2034
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Dec 2, 2025 · Synced Sep 11, 2026, 9:32 PM EDT
Completed Phase 2 Interventional Results available

Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma

NCT01245673
View directory record Official record
Conditions
Myeloma
Interventions
Prevnar- Pneumococcal Conjugate Vaccine (PCV), Activated/costimulated autologous T-cell, Revlamid® (Lenalidomide), MAGE-A3/GM-GSF, Hiltonol® (Poly-ICLC)
Biological · Other · Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years to 80 Years
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2018
U.S. locations
2
States / cities
Baltimore, Maryland • Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Apr 5, 2020 · Synced Sep 11, 2026, 9:32 PM EDT
Recruiting Phase 1 Interventional

KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer

NCT06411691
View directory record Official record
Conditions
Colorectal Cancer, Pancreatic Cancer
Interventions
KRAS Vaccine with Poly-ICLC adjuvant, Balstilimab, Botensilimab
Drug
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Eligibility
18 Years and older
Enrollment
54 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2030
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Jul 30, 2026 · Synced Sep 11, 2026, 9:32 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Safety Study of Adjuvant Vaccine to Treat Melanoma Patients

NCT01079741
View directory record Official record
Conditions
Melanoma
Interventions
NY-ESO-1 protein; Poly-ICLC; Montanide
Biological
Lead sponsor
Nina Bhardwaj
Other
Eligibility
18 Years and older
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Feb 12, 2018 · Synced Sep 11, 2026, 9:32 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Enhancement by Poly-ICLC During HIV-1 Infection

NCT02071095
View directory record Official record
Conditions
HIV-1 Infected Adults With Chronic HIV-1 Infection
Interventions
Arm A: Poly-ICLC, Arm B: Normal Saline
Drug
Lead sponsor
Nina Bhardwaj
Other
Eligibility
18 Years to 55 Years
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Mar 12, 2018 · Synced Sep 11, 2026, 9:32 PM EDT
Active, not recruiting Phase 1 Interventional Results available

ETAPA I: Peptide-based Tumor Associated Antigen Vaccine in GBM

NCT05283109
View directory record Official record
Conditions
Glioma, Malignant
Interventions
Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine, Hiltonol
Biological · Drug
Lead sponsor
Mustafa Khasraw, MBChB, MD, FRCP, FRACP
Other
Eligibility
18 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Apr 29, 2026 · Synced Sep 11, 2026, 9:32 PM EDT
Terminated Phase 1 Interventional

Neoepitope-based Personalized Vaccine Approach in Patients With Newly Diagnosed Glioblastoma

NCT02510950
View directory record Official record
Conditions
Glioblastoma Multiforme, Astrocytoma, Grade IV
Interventions
Personalized peptide vaccine, Poly-ICLC, Temozolomide
Biological · Drug
Lead sponsor
Washington University School of Medicine
Other
Eligibility
18 Years and older
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
1
States / cities
St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Nov 16, 2017 · Synced Sep 11, 2026, 9:32 PM EDT
Recruiting Phase 1Phase 2 Interventional

Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer

NCT01720836
View directory record Official record
Conditions
Non-small Cell Lung Cancer (NSCLC)
Interventions
Vaccine + PolyICLC
Biological
Lead sponsor
Olivera Finn
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2032
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Oct 20, 2025 · Synced Sep 11, 2026, 9:32 PM EDT
Terminated Phase 2 Interventional Results available

Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC)

NCT01984892
View directory record Official record
Conditions
Melanoma, Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma of the Skin, Sarcoma of the Skin, Basal Cell Cancer of the Skin, Breast Cancer
Interventions
Poly-ICLC
Drug
Lead sponsor
Nina Bhardwaj
Other
Eligibility
14 Years and older
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jan 22, 2018 · Synced Sep 11, 2026, 9:32 PM EDT