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

26 days 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)

26d

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

26 days 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

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.

1 month 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)

Evaluation of Antibodies Induced by Melanoma Helper Peptide Vaccine and Their Modulation by Vaccine Adjuvants. (PubMed, Vaccines (Basel))

Vaccine-induced Abs may respond to multiple epitopes within the same peptide, warranting further studies into their ability to facilitate antigen uptake and presentation through the formation of large immune complexes. The findings also show that adding polyICLC to IFA can significantly enhance Ab responses. Collectively, this work underscores the immunologic potential of peptide-induced Abs and the importance of adjuvant selection in cancer vaccine design.

1 month ago

Journal

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

cyclophosphamide • 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

1 month ago

New P1 trial

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

Opdivo (nivolumab) • Yervoy (ipilimumab) • sirpiglenastat (DRP-104) • DNAJB1-PRKACA peptide vaccine • Hiltonol (poly-ICLC)

2ms

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

P1, N=6, Active, not recruiting, Jonsson Comprehensive Cancer Center | Recruiting --> Active, not recruiting

2 months ago

Enrollment closed

Hiltonol (poly-ICLC)

3ms

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

P1, N=32, Recruiting, Washington University School of Medicine | N=16 --> 32

3 months ago

Enrollment change

Signatera™

Hiltonol (poly-ICLC)

3ms

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=14, Active, not recruiting, University of Southern California | Recruiting --> Active, not recruiting | Trial completion date: Jan 2027 --> Jan 2028 | Trial primary completion date: Jan 2026 --> Jan 2027

3 months ago

Enrollment closed • Trial completion date • Trial primary completion date • IO biomarker

HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)

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

3ms

Peptide Vaccines for Pediatric High-Grade Glioma and Diffuse Midline Glioma: Current Progress and Future Perspectives. (PubMed, Vaccines (Basel))

However, the unique challenges of the immunosuppressive tumor microenvironment and the detrimental effect of necessary corticosteroids remain paramount barriers. Future success relies on multi-modal combination strategies, the development of next-generation personalized neoantigen vaccines, and the application of advanced neuroimaging to accurately assess treatment response.

3 months ago

Review • Journal

BIRC5 (Baculoviral IAP repeat containing 5)

H3.3K27M

temozolomide • Hiltonol (poly-ICLC)