NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma
NCT04930783 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-03-25
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)
Conditions
Interventions
- 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
-
Administered intravenously (IV)
- DRUG
-
Administered intravenously (IV)
Sponsors & Collaborators
-
Celldex Therapeutics
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Patrick A Ott, MD, PhD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-03
- Primary Completion
- 2027-12-31
- Completion
- 2030-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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