NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04930783
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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)

Key Dates

Start date
Jan 3, 2022
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Sep 30, 2030

Study Design

Enrollment
10 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CDX-301 + Neovax + Nivolumab
    * Participants will have vaccine made from tissue collected from metastatic tumor biopsy or surgical resection, or from previously collected archival biopsy or surgical tissue. * Participants will receive Nivolumab at a flat dose every 4 weeks up to two years. * Participants will receive CDX-301 at a predetermined dose dependent on the number of participants previously enrolled for 5 days starting 2 days before the initiation of NeoVax. CDX-301 will then be administered at a predetermined dose dependent on the number of participants previously enrolled 2 days before and for 5 days coinciding with the administration of NeoVax on days 50 and 78.
  • Experimental: CDX-301 + Neovax + Pembrolizumab
    * Participants will have vaccine made from tissue collected from tumor biopsy, or from previously collected archival biopsy or surgical tissue. * Participants will receive neoadjuvant Pembrolizumab for 3 doses every 3 weeks, then undergo standard-of-care surgical resection. * Participants will receive adjuvant NeoVax and CDX-301. CDX-301 will be administered at a predetermined dose, dependent on the number of participants previously enrolled, for 5 days starting 2 days before the initiation of NeoVax. CDX-301 will then be administered at a predetermined dose dependent on the number of participants previously enrolled 2 days before and for 5 days coinciding with the administration of NeoVax on days 50 and 78. * Participants will receive adjuvant Pembrolizumab for 15 doses every 6 weeks.

Primary Outcome Measure

Rate of Dose Limiting Toxicity (DLT) [ Time Frame: Toxicities experienced within 49 days/7 weeks of Neoantigen Vaccine treatment initiation ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215-

Find similar trials in Boston, MA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Dana-Farber Cancer Institute· Boston, MA

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