NeoVax With Nivolumab in Patients With Ovarian Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04024878
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab (Opdivo®) is an antibody. An antibody is a common type of protein produced by the body that the immune system uses to find and destroy foreign molecules.
  • NeoVax — BIOLOGICAL
    The vaccine will consist of up to 20 peptides as well as a drug that activates the immune system called Poly-ICLC. Poly-ICLC (also called Hiltonol) is an experimental "viral mimic" and an activator of immunity
  • Core Needle Biopsy — PROCEDURE
    Surgical procedure

Study Details

This research study is evaluating a new type of vaccine called "Personalized NeoAntigen Cancer Vaccine" in combination with Nivolumab (Opdivo®) for ovarian cancer.

Key Dates

Start date
Nov 20, 2020
Status verified
Jun 2025
Primary completion
Apr 30, 2025
Completion
Apr 30, 2029

Study Design

Enrollment
22 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stanfard Platinum
    * A total of 5 NeoVax immunizations will be administered over a 3-week period * Two booster vaccinations will be given at Week 12 * Nivolumab administered by intravenous (IV) infusion over 30 minutes every 2 weeks.
  • Experimental: Stanfard Platinum with Surgical or Core Needle Biopsy
    * A total of 5 NeoVax immunizations will be administered over a 3-week period * Two booster vaccinations will be given at Week 12 * Nivolumab administered by intravenous (IV) infusion over 30 minutes every 2 weeks. * Will undergo required surgical or core needle biopsy at first recurrence with progression free interval

Primary Outcome Measure

Percentage of patients pre-srceened who have enough neoantigens for generation of the vaccine, are not platinum refractory, and who initiate vaccination [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-

Find similar trials in Boston, MA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Dana Farber Cancer Institute· Boston, MA

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