The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Adrienne G. Waks
Study ID
NCT03414658
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Vinorelbine — DRUG
    work by interfering with cell division, which leaves the tumor unable to grow and spread
  • Trastuzumab — DRUG
    trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.
  • Avelumab — DRUG
    monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein
  • Utomilumab — DRUG
    Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells

Study Details

This research study is studying a combination of drugs as a possible treatment for breast cancer. The drugs involved in this study are: * Group A: Trastuzumab (Herceptin) + Vinorelbine (Navelbine) * Group B: Trastuzumab + Vinorelbine + Avelumab * Group C: Trastuzumab + Vinorelbine + Avelumab + Utomilumab (PF-05082566)

Key Dates

Start date
Jun 21, 2018
Status verified
Jun 2025
Primary completion
May 1, 2023
Completion
May 31, 2026

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NH: Trastuzumab + Vinorelbine
    * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle
  • Experimental: NHA: Trastuzumab + Vinorelbine + Avelumab
    * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab
  • Experimental: NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab
    * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab * Utomilumab is administered intravenously once per cycle

Primary Outcome Measure

Progression Free Survival [ Time Frame: 2 years ]

Locations (17)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35249-
University of California San FranciscoSan FranciscoCalifornia94158-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
University of Chicago Medical CenterChicagoIllinois60637-
Indiana University Health Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Johns Hopkins UniversityBaltimoreMaryland21287-
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Montefiore Medical CenterThe BronxNew York10467-
University of Carolina at Chapel HillChapel HillNorth Carolina27599-7305-
Duke University Medical CenterDurhamNorth Carolina27710-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Baylor College of MedicineHoustonTexas77030-
MD Anderson Cancer CenterHoustonTexas77030-
University of Washington Fred Hutchinson Cancer CareSeattleWashington98109-

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of California San Francisco· San Francisco, CAGeorgetown University Medical Center· Washington D.C., DCUniversity of Chicago Medical Center· Chicago, ILIndiana University Health Melvin and Bren Simon Cancer Center· Indianapolis, INJohns Hopkins University· Baltimore, MD

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