NCT04930783

NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma

A Phase Ib Study of NeoVax in Combination With CDX-301 and Nivolumab or Pembrolizumab and in Patients With Melanoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying the drugs called NeoVax (a new type of personalized neoantigen vaccine) in combination with CDX-301 and Nivolumab or Pembrolizumab as a possible treatment for melanoma. The names of the study drugs involved in this study are: * Personalized Neoantigen peptides (which combined with poly-ICLC make the vaccine NeoVax) * Poly-ICLC (Hiltonol) * CDX-301 * Nivolumab (Opdivo) * Pembrolizumab (Keytruda)

Detailed description

The purpose of this Phase I study is to determine if it is possible to safely administer a personalized neoantigen vaccine (NeoVax) in combination with the study drug CDX-301 and Nivolumab or Pembrolizumab against melanoma by using information gained from specific characteristics of someone's own melanoma. The study will also be determining what the appropriate dose of CDX-301 to be given in combination with NeoVax and Nivolumab or Pembrolizumab. The FDA (the U.S. Food and Drug Administration) has not approved personalized neoantigen peptides, poly-ICLC , or CDX-301 as a treatment for any disease. The FDA has approved Nivolumab and Pembrolizumab as a treatment option for melanoma. It is known that melanoma cancers have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells.It is possible that these proteins used in a vaccine may induce strong immune responses, which may help someone's body fight any tumor cells that could cause the melanoma to come back in the future. The personalized Neovax vaccine will be made of protein fragments, called peptides, from an individual's mutated melanoma tumor cells mixed with Poly-ICLC. Poly-ICLC is a drug that binds proteins on the surface of certain immune cells and helps to activate the immune system. CDX-301 is a drug involved in regulating the activity and proliferation of a type of cell named dendritic cell. Dendritic cells are key in enhancing the activation of the immune system in response to the NeoVax vaccine, so the immune system has a better chance to recognize the tumor cells and attack them. Nivolumab and Pembrolizumab are antibodies that prevent cancer cells from suppressing one's immune response so that their body can attack and kill the cancer. The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive study treatment for as long as they do not have serious side effects and their disease does not get worse for a maximum of 2 years and will be followed for 5 years since study therapy initiation It is expected that about 30 people will take part in this research study Celldex Therapeutics is supporting this research by providing CDX-301.

Conditions

• Melanoma
• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	CDX-301	Administered as an injection given underneath the skin
BIOLOGICAL	NEOVAX	Personalized neoantigen vaccine administered as an injection given underneath the skin
DRUG	Nivolumab	Administered intravenously (IV)
DRUG	Pembrolizumab	Administered intravenously (IV)

Timeline

• Start date: 2022-01-03
• Primary completion: 2027-12-31
• Completion: 2030-09-30
• First posted: 2021-06-18
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study