P1, N=30, Not yet recruiting, Washington University School of Medicine | Trial completion date: Dec 2034 --> Mar 2035 | Initiation date: Mar 2026 --> Jun 2026 | Trial primary completion date: Jan 2030 --> Apr 2030

3 days ago

Trial completion date • Trial initiation date • Trial primary completion date

Keytruda (pembrolizumab) • carboplatin • paclitaxel • doxorubicin hydrochloride • cyclophosphamide • Hiltonol (poly-ICLC)

The Phase Ib IMPACT Trial of Intramuscular Personalized Neoantigen Synthetic Long Peptide Vaccines in Patients with Advanced Melanoma and Renal Cell Carcinoma. (PubMed, Clin Cancer Res)

Intramuscular neoantigen SLP vaccination with poly-ICLC is safe and induces rapid, mutation-specific T-cell immunity with robust CD8⁺ effector responses. These findings support intramuscular administration as a promising strategy for peptide-based cancer vaccines.

3 days ago

P1 data • Journal • IO biomarker

CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule)

Hiltonol (poly-ICLC)

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

P1, N=27, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: May 2030 --> Aug 2030 | Initiation date: May 2026 --> Aug 2026 | Trial primary completion date: May 2026 --> Aug 2030

3 days ago

Trial completion date • Trial initiation date • Trial primary completion date

DNAJB1 (DnaJ Heat Shock Protein Family (Hsp40) Member B1) • PRKACA (Protein Kinase CAMP-Activated Catalytic Subunit Alpha)

Opdivo (nivolumab) • Yervoy (ipilimumab) • sirpiglenastat (DRP-104) • Hiltonol (poly-ICLC)

PANCOV: Dose Escalation Trial of CD40.Pan.CoV Vaccine, Adjuvanted or Not, as a Booster in Adult Healthy Volunteers (clinicaltrials.gov)

P1/2, N=48, Active, not recruiting, ANRS, Emerging Infectious Diseases | Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2026 --> Oct 2026

5 days ago

Enrollment closed • Trial primary completion date

Hiltonol (poly-ICLC)

18d

Personalized Neoantigen Cancer Vaccine for Patients With Solid Tumors (clinicaltrials.gov)

P1/2, N=8, Completed, Seqker Biosciences, Inc. | Active, not recruiting --> Completed

18 days ago

Trial completion • IO biomarker

Hiltonol (poly-ICLC)

23d

Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM (clinicaltrials.gov)

P1, N=56, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting

23 days ago

Enrollment closed

MGMT (6-O-methylguanine-DNA methyltransferase)

MGMT promoter methylation

Keytruda (pembrolizumab) • temozolomide • Hiltonol (poly-ICLC) • Neo Vax (NEO-PV-01)

PANCOV: Dose Escalation Trial of CD40.Pan.CoV Vaccine, Adjuvanted or Not, as a Booster in Adult Healthy Volunteers (clinicaltrials.gov)

P1/2, N=48, Recruiting, ANRS, Emerging Infectious Diseases

1 month ago

Trial initiation date

Hiltonol (poly-ICLC)

2ms

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 | Trial primary completion date: Sep 2025 --> Sep 2026

2 months ago

Trial primary completion date

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

2ms

HCC 21-208: 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 | Trial completion date: Aug 2028 --> Mar 2029 | Trial primary completion date: Jan 2026 --> Aug 2026

2 months ago

Trial completion date • Trial primary completion date

MUC1 (Mucin 1)

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

2ms

Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM (clinicaltrials.gov)

P1, N=56, Recruiting, Dana-Farber Cancer Institute | Trial completion date: Feb 2027 --> Feb 2028 | Trial primary completion date: Feb 2026 --> Feb 2027

2 months ago

Trial completion date • Trial primary completion date

MGMT (6-O-methylguanine-DNA methyltransferase)

MGMT promoter methylation

Keytruda (pembrolizumab) • temozolomide • Hiltonol (poly-ICLC) • Neo Vax (NEO-PV-01)

2ms

Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma, Hormone Receptor Positive HER2 Negative Metastatic Refractory Breast Cancer or Stage III-IV Non-Small Cell Lung Cancer (clinicaltrials.gov)

P1, N=25, Recruiting, Fred Hutchinson Cancer Center | Trial primary completion date: Nov 2026 --> Nov 2027 | Trial completion date: Nov 2027 --> Nov 2028

2 months ago

Trial completion date • Trial primary completion date

HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PGR (Progesterone receptor) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)

KRAS mutation • ER positive • EGFR mutation • HR positive • BRAF mutation • HER-2 negative

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

2ms

Phase I/II clinical trial of a melanoma vaccine targeting shared non-mutated antigens and a shared mutated BRAF neoantigen with an agonistic CD40 antibody (CDX-1140) plus TLR3 agonist (poly-ICLC). (PubMed, J Immunother Cancer)

The vaccine was safe, well-tolerated, and immunogenic. Optimization of vaccines that include agonistic CD40 antibody is needed to enhance immunogenicity. Induction of a multifunctional CD4+ T cell response to mBRAF supports targeting shared mutated neoantigens with melanoma vaccines.

2 months ago

P1/2 data • Journal • IO biomarker • First-in-human

BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8) • LAMP3 (Lysosomal Associated Membrane Protein 3) • CD40 (CD40 Molecule)

BRAF V600E • BRAF mutation • BRAF V600

CDX-1140 • Hiltonol (poly-ICLC)