Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
Massachusetts General Hospital
Study ID
NCT02826434
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • PVX-410 — BIOLOGICAL
    This is a Vaccine that will be injected intramuscularly as a mixture with an adjuvant.
  • Durvalumab — BIOLOGICAL
    This is an intravenous infusion of a monoclonal antibody.
  • Hiltonol — DRUG
    This is an intramuscular injection of an adjuvant to enhance the immune response to vaccine.

Study Details

The purpose of this research study is to evaluate Immunotherapy with a peptide vaccine and Programmed Death Ligand 1 (PD-L1) inhibitor as a possible adjuvant treatment for Stage II or III Triple Negative Breast Cancer. This research study is studying the safety, tolerability, and immune response of these treatments. The names of the study interventions involved in this study are: * PVX-410 Vaccine * Durvalumab (MEDI4736)

Key Dates

Start date
Aug 18, 2016
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PVX-410 and Durvalumab
    Each patient will receive 6 PVX-410 vaccine injections and 2 infusions of Durvalumab. * The injection of PVX-410 will be co-administered with Hiltonol every 2 weeks for 6 injections. * The infusion of Durvalumab will be given on the day of the 4th and 6th PVX-410 injection, for a total of 2 infusions.

Primary Outcome Measure

Dose Limiting Toxicity Rate of PVX-410 in Combination With Durvalumab [ Time Frame: 4 Weeks ]

Locations (5)

FacilityCityStateZIPSite coordinators
Lee Moffitt Cancer Center and Research InstituteTampaFlorida33607-
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts general HospitalBostonMassachusetts02114-
New York University School of MedicineNew YorkNew York10016-

Find similar trials in Tampa, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Lee Moffitt Cancer Center and Research Institute· Tampa, FLBeth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MAMassachusetts general Hospital· Boston, MANew York University School of Medicine· New York, NY

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