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

First listed
Jun 18, 2021
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

Nationwide
Melanoma trialsOncology trialsSkin cancer trialsDermatology trials
By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Dana-Farber Cancer Institute· Boston, MA

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