P2, N=70, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Nov 2025 | Trial primary completion date: Dec 2024 --> Nov 2025

5 days ago

Trial completion date • Trial primary completion date • Metastases

HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD4 (CD4 Molecule)

PD-L1 expression • HER-2 negative • PD-L1 negative

carboplatin • Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • Imjudo (tremelimumab-actl) • Trodelvy (sacituzumab govitecan-hziy) • Hiltonol (poly-ICLC)

1B-22-2: In Situ Immunomodulation with CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients W/ Unresectable and Metastatic Solid Tumors (clinicaltrials.gov)

P1, N=18, Recruiting, University of Southern California | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2025 --> Jan 2026

7 days ago

Trial completion date • Trial primary completion date • Immunomodulating • Metastases

HER-2 (Human epidermal growth factor receptor 2)

Keytruda (pembrolizumab) • CDX-1140 • Hiltonol (poly-ICLC) • Mobista (CDX-301)

14d

A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma (clinicaltrials.gov)

P1, N=6, Recruiting, Jonsson Comprehensive Cancer Center | Not yet recruiting --> Recruiting | Initiation date: Dec 2024 --> Jun 2024

14 days ago

Enrollment open • Trial initiation date

Hiltonol (poly-ICLC)

Neo-adjuvant Evaluation of Glioma Lysate Vaccines in WHO Grade II Glioma (clinicaltrials.gov)

P1, N=28, Completed, Jennie Taylor | Active, not recruiting --> Completed

1 month ago

Trial completion

CD8 (cluster of differentiation 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10)

CXCL10 expression

GBM6-AD • Hiltonol (poly-ICLC)

Intratumoral administration of poly-ICLC enhances the antitumor effects of anti-PD-1. (PubMed, J Hepatobiliary Pancreat Sci)

Combination therapy with poly-ICLC, especially through IT route, and anti-PD-1 provides significantly greater antitumor effects than anti-PD-1 monotherapy in syngeneic mouse models of HCC.

1 month ago

Journal

CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)

nCounter® PanCancer IO 360™ Panel

Hiltonol (poly-ICLC)

2ms

Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in the HVTN706/MOSAICO Study and Remain Without HIV (clinicaltrials.gov)

P1, N=40, Not yet recruiting, National Institute of Allergy and Infectious Diseases (NIAID)

2 months ago

New P1 trial

CD40 (CD40 Molecule)

Hiltonol (poly-ICLC)

2ms

KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer (clinicaltrials.gov)

P1, N=50, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting | Phase classification: P2 --> P1

2 months ago

Enrollment open • Phase classification • Metastases

balstilimab (AGEN2034) • botensilimab (AGEN1181) • Hiltonol (poly-ICLC)

2ms

Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma (clinicaltrials.gov)

P1, N=40, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Dec 2025 --> Aug 2026 | Trial primary completion date: Dec 2024 --> Aug 2025

2 months ago

Trial completion date • Trial primary completion date • IO biomarker

PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule)

Keytruda (pembrolizumab) • Hiltonol (poly-ICLC)

2ms

Regulatory T cells modulate monocyte functions in immunocompetent antiretroviral therapy naive HIV-1 infected people. (PubMed, BMC Immunol)

We observed that Treg cells were able to down modulate autologous monocytes activation as well as interleukin 6 (IL-6) and tumor necrosis factor-alpha (TNF-α) production during stimulation with polyinosinic-polycytidylic acid stabilized with poly-L-lysine and carboxymethylcellulose (poly-ICLC)...Compared to immunosuppressed participants (CD4 < 500 cells/µL), immunocompetent participants (CD4 ≥ 500 cells/µL) showed significantly higher levels of transforming growth factor beta (TGF-β) and IL-10 (p < 0.001 and p < 0.05, respectively), key cytokines used by Treg cells to exert their immunosuppressive functions. Our findings suggest the contribution of both TGF-β and IL-10 in the suppressive activity of Treg cells.

2 months ago

Journal

IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • IL10 (Interleukin 10) • TGFB1 (Transforming Growth Factor Beta 1)

Hiltonol (poly-ICLC)

3ms

Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer (clinicaltrials.gov)

P1, N=22, Active, not recruiting, Massachusetts General Hospital | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Jun 2024 --> Jun 2025

3 months ago

Trial completion date • Trial primary completion date

HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)

HER-2 negative • HLA-A2 positive

Imfinzi (durvalumab) • Hiltonol (poly-ICLC) • PVX-410

3ms

Mel 70: FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma (clinicaltrials.gov)

P1, N=11, Recruiting, University of Virginia | Not yet recruiting --> Recruiting

3 months ago

Enrollment open • Metastases

Hiltonol (poly-ICLC)

3ms

HAITEN-ICI: Harnessing Allo-immunity to Enhance Immune Checkpoint Inhibitor Responses in Advanced NSCLC (clinicaltrials.gov)

P1/2, N=0, Withdrawn, VA Office of Research and Development | N=16 --> 0 | Trial completion date: Apr 2028 --> Jun 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jun 2026 --> Jun 2024

3 months ago

Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Checkpoint inhibition • Metastases

PD-L1 (Programmed death ligand 1)

Hiltonol (poly-ICLC)

4ms

Dendritic Cell Vaccine for Patients With Brain Tumors (clinicaltrials.gov)

P2, N=24, Completed, Jonsson Comprehensive Cancer Center | Active, not recruiting --> Completed | N=60 --> 24 | Trial completion date: Jan 2026 --> Aug 2024 | Trial primary completion date: Jan 2025 --> Aug 2024

4 months ago

Trial completion • Enrollment change • Trial completion date • Trial primary completion date

Hiltonol (poly-ICLC)

4ms

Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma (clinicaltrials.gov)

P1, N=40, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Aug 2026 --> Dec 2025 | Trial primary completion date: Aug 2025 --> Dec 2024

4 months ago

Trial completion date • Trial primary completion date • IO biomarker

PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule)

Keytruda (pembrolizumab) • Hiltonol (poly-ICLC)

4ms

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

P1, N=25, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

4 months ago

New P1 trial

CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)

Imfinzi (durvalumab) • Imjudo (tremelimumab-actl) • Hiltonol (poly-ICLC)

4ms

Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma (clinicaltrials.gov)

P1, N=40, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Aug 2025 --> Aug 2026 | Trial primary completion date: Aug 2024 --> Aug 2025

4 months ago

Trial completion date • Trial primary completion date • IO biomarker

PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule)

Keytruda (pembrolizumab) • Hiltonol (poly-ICLC)

5ms

Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer (clinicaltrials.gov)

P1, N=37, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | N=25 --> 37

5 months ago

Enrollment change

KRAS (KRAS proto-oncogene GTPase) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATM (ATM serine/threonine kinase) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • IFNG (Interferon, gamma) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • CD4 (CD4 Molecule) • EPCAM (Epithelial cell adhesion molecule) • PMS1 (PMS1 protein homolog 1)

Hiltonol (poly-ICLC)

5ms

Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease (clinicaltrials.gov)

P1, N=16, Not yet recruiting, Washington University School of Medicine

5 months ago

New P1 trial

Opdivo (nivolumab) • Hiltonol (poly-ICLC)

5ms

Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma or Hormone Receptor Positive Her2 Negative Metastatic Refractory Breast Cancer (clinicaltrials.gov)

P1, N=20, Recruiting, Fred Hutchinson Cancer Center | Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2024 --> Nov 2025

5 months ago

Trial completion date • Trial primary completion date • Metastases

HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • PGR (Progesterone receptor)

Opdivo (nivolumab) • Hiltonol (poly-ICLC) • PNV21 vaccine

5ms

Mel66: Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma) (clinicaltrials.gov)

P1/2, N=22, Completed, Craig L Slingluff, Jr | Active, not recruiting --> Completed | Trial completion date: May 2025 --> Mar 2024 | Trial primary completion date: Sep 2024 --> Mar 2024

5 months ago

Trial completion • Trial completion date • Trial primary completion date

BRAF (B-raf proto-oncogene) • CD4 (CD4 Molecule)

CDX-1140 • Hiltonol (poly-ICLC)

6ms

Mel 70: FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma (clinicaltrials.gov)

P1, N=11, Not yet recruiting, University of Virginia

6 months ago

New P1 trial • Metastases

Hiltonol (poly-ICLC)

6ms

A Study of Varlilumab and IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG) (clinicaltrials.gov)

P1, N=14, Terminated, Nicholas Butowski | Active, not recruiting --> Terminated; Industry sponsor decision

6 months ago

Trial termination

CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)

varlilumab (CDX 1127) • Hiltonol (poly-ICLC) • IMA950

6ms

Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery (clinicaltrials.gov)

P1, N=30, Recruiting, Washington University School of Medicine | Active, not recruiting --> Recruiting

6 months ago

Enrollment open • Surgery

Hiltonol (poly-ICLC)

7ms

KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer (clinicaltrials.gov)

P2, N=50, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Phase classification: P1 --> P2

7 months ago

Phase classification • Metastases

balstilimab (AGEN2034) • botensilimab (AGEN1181) • Hiltonol (poly-ICLC)

7ms

GCC-16047: Pembrolizumab + Poly-ICLC in MRP Colon Cancer (clinicaltrials.gov)

P1/2, N=42, Completed, Asha Nayak | N=31 --> 42

7 months ago

Enrollment change • Mismatch repair • Metastases

PD-L1 (Programmed death ligand 1)

Keytruda (pembrolizumab) • Hiltonol (poly-ICLC)

7ms

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 (clinicaltrials.gov)

P1, N=15, Not yet recruiting, Jonsson Comprehensive Cancer Center | Trial primary completion date: May 2029 --> Dec 2029

7 months ago

Trial primary completion date • Combination therapy

Opdivo (nivolumab) • Yervoy (ipilimumab) • Hiltonol (poly-ICLC)

7ms

A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma (clinicaltrials.gov)

P1, N=6, Not yet recruiting, Jonsson Comprehensive Cancer Center | Initiation date: May 2024 --> Dec 2024

7 months ago

Trial initiation date

Hiltonol (poly-ICLC)

7ms

KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer (clinicaltrials.gov)

P1, N=50, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

7 months ago

New P1 trial • Metastases

balstilimab (AGEN2034) • botensilimab (AGEN1181) • Hiltonol (poly-ICLC)

8ms

TLR agonists polarize interferon responses in conjunction with dendritic cell vaccination in malignant glioma: a randomized phase II Trial. (PubMed, Nat Commun)

Patients that exhibit higher interferon response gene expression demonstrate prolonged survival and delayed disease progression. These findings suggest that combining ATL-DC with poly-ICLC can induce a polarized interferon response in circulating monocytes and CD8+ T cells, which may represent an important blood biomarker for immunotherapy in this patient population.Trial Registration: ClinicalTrials.gov Identifier: NCT01204684.

8 months ago

Clinical • P2 data • Clinical Trial,Phase II • Journal • PD(L)-1 Biomarker • IO biomarker

CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD38 (CD38 Molecule) • CD4 (CD4 Molecule) • ENTPD1 (Ectonucleoside Triphosphate Diphosphohydrolase 1)

PD-1 expression • CD8 expression • ENTPD1 expression

Hiltonol (poly-ICLC)

8ms

HAITEN-ICI: Harnessing Allo-immunity to Enhance Immune Checkpoint Inhibitor Responses in Advanced NSCLC (clinicaltrials.gov)

P1/2, N=16, Not yet recruiting, VA Office of Research and Development | Trial primary completion date: Mar 2026 --> Jun 2026

8 months ago

Trial primary completion date • Checkpoint inhibition • Metastases

PD-L1 (Programmed death ligand 1)

Hiltonol (poly-ICLC)

8ms

Dendritic Cell Vaccine for Patients With Brain Tumors (clinicaltrials.gov)

P2, N=60, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2024 --> Jan 2025

8 months ago

Trial completion date • Trial primary completion date

Hiltonol (poly-ICLC)

8ms

A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM (clinicaltrials.gov)

P1, N=19, Active, not recruiting, Massachusetts General Hospital | Phase classification: P1b --> P1 | Trial completion date: Jun 2023 --> Sep 2024 | Trial primary completion date: Jun 2023 --> Sep 2024

8 months ago

Phase classification • Trial completion date • Trial primary completion date • Epigenetic controller

lenalidomide • Hiltonol (poly-ICLC) • PVX-410 • citarinostat (ACY-241)

9ms

Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)

P1/2, N=75, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025

9 months ago

Trial completion date • Trial primary completion date • IO biomarker

PD-L1 (Programmed death ligand 1) • CTAG1B (Cancer/testis antigen 1B)

PD-L1 expression • CTAG1B expression

Tecentriq (atezolizumab) • Hiltonol (poly-ICLC) • guadecitabine (SGI-110) • rasdegafusp alfa (CDX-1401)

9ms

A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma (clinicaltrials.gov)

P1, N=6, Not yet recruiting, Jonsson Comprehensive Cancer Center

9 months ago

New P1 trial

Hiltonol (poly-ICLC)

9ms

Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery (clinicaltrials.gov)

P1, N=25, Active, not recruiting, Washington University School of Medicine | Recruiting --> Active, not recruiting

9 months ago

Enrollment closed • Surgery

Hiltonol (poly-ICLC)

9ms

Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm (clinicaltrials.gov)

P1, N=10, Recruiting, Marina Kremyanskaya | Trial completion date: Jan 2025 --> Mar 2026 | Trial primary completion date: Jan 2024 --> Mar 2026

9 months ago

Trial completion date • Trial primary completion date

CALR (Calreticulin)

CALR mutation

Hiltonol (poly-ICLC)

10ms

NF111: A Phase II Trial of Poly-ICLC for Low-Grade Gliomas (clinicaltrials.gov)

P2, N=20, Recruiting, University of Alabama at Birmingham | Trial completion date: Feb 2026 --> Feb 2027 | Trial primary completion date: Feb 2025 --> Feb 2026

10 months ago

Trial completion date • Trial primary completion date

NF1 (Neurofibromin 1)

NF1 mutation

Hiltonol (poly-ICLC)

10ms

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

P1, N=13, Active, not recruiting, Albert Einstein College of Medicine | Trial completion date: May 2024 --> May 2025

10 months ago

Trial completion date

Hiltonol (poly-ICLC)

10ms

Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ (clinicaltrials.gov)

P1, N=50, Recruiting, Finn, Olivera, PhD | Not yet recruiting --> Recruiting | Trial completion date: Jul 2027 --> Aug 2028

10 months ago

Enrollment open • Trial completion date

MUC1 (Mucin 1)

letrozole • anastrozole • exemestane • Hiltonol (poly-ICLC)

10ms

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 (clinicaltrials.gov)

P1, N=30, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2024 --> Aug 2025 | Trial primary completion date: Dec 2024 --> Aug 2025

10 months ago

Trial completion date • Trial primary completion date • Mismatch repair

KRAS (KRAS proto-oncogene GTPase) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)

KRAS mutation

Opdivo (nivolumab) • Yervoy (ipilimumab) • Hiltonol (poly-ICLC) • KRAS peptide vaccine

10ms

H3.3K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other Gliomas (clinicaltrials.gov)

P1/2, N=50, Completed, Sabine Mueller, MD, PhD | Active, not recruiting --> Completed | Trial completion date: Nov 2024 --> Dec 2023 | Trial primary completion date: Nov 2024 --> Dec 2023

10 months ago

Trial completion • Trial completion date • Trial primary completion date

HLA-A (Major Histocompatibility Complex, Class I, A)

HLA-A*02:01 • H3.3K27M • HLA-A*02 • HLA-A2 positive

Opdivo (nivolumab) • Hiltonol (poly-ICLC)

10ms

HAITEN-ICI: Harnessing Allo-immunity to Enhance Immune Checkpoint Inhibitor Responses in Advanced NSCLC (clinicaltrials.gov)

P1/2, N=16, Not yet recruiting, VA Office of Research and Development | Trial completion date: Dec 2028 --> Apr 2028 | Trial primary completion date: Dec 2025 --> Mar 2026

10 months ago

Trial completion date • Trial primary completion date • Checkpoint inhibition • Metastases

PD-L1 (Programmed death ligand 1)

Hiltonol (poly-ICLC)