A Randomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects With Residual Disease or High-Risk PCR After Both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01)
Summary
This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A\*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A\*02 positive and HER2/neu positive subjects.
Arms & interventions
- BiologicalPlacebo
0.9% Normal Saline
- BiologicalGLSI-100
500 mcg/mL GP2 and 125 mcg/mL GM-CSF
Outcome measures
Primary
Invasive Breast Cancer-free Survival (IBCFS)
IBCFS is defined as the time from the first dose of study medication until the date of ipsilateral invasive breast cancer recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or any cause mortality.
Time frame: Median 4 years of follow-up (interim analysis planned)
Secondary
Invasive Disease-free Survival (IDFS)
Time frame: Median 4 years of follow-up (interim analysis planned)
Distant Disease-free Survival (DDFS)
Time frame: Median 4 years of follow-up (interim analysis planned)
Overall Survival
Time frame: Median 4 years of follow-up (interim analysis planned)
Quality of Life Questionnaire Core 30 (QLQ-C30)
Time frame: Baseline and 36 months
Quality of Life FACT-GP5
Time frame: Baseline and 36 months
Eligibility criteria
Study locations (51)
Southern Cancer Center
Mobile, Alabama, 36607
City of Hope - Cancer Center Phoenix
Goodyear, Arizona, 85338
Tucson Medical Center HealthCare
Tucson, Arizona, 85704
City of Hope - Duarte Cancer Center
Duarte, California, 91010
Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center
Fullerton, California, 92835
City of Hope - Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
University of California San Diego - Moores Cancer Center
La Jolla, California, 92093
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Stanford Medicine Cancer Center - Stanford Women's Cancer Center
Palo Alto, California, 74304
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
University of California Los Angeles - Hematology / Oncology Parkside
Santa Monica, California, 90404
PIH Health Hospital - Whittier Hospital
Whittier, California, 90602
Rocky Mountain Cancer Centers
Denver, Colorado, 80220
Yale Cancer Center - Smilow Cancer Hospital
New Haven, Connecticut, 06511
Johns Hopkins Medicine - Kimmel Cancer Center-Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33146
Moffitt Cancer Center
Tampa, Florida, 33612
City of Hope - Cancer Center Atlanta
Newnan, Georgia, 30265
Northwestern University - Northwestern Memorial Hospital
Chicago, Illinois, 60611
City of Hope - Cancer Center Chicago
Zion, Illinois, 60099
Maryland Oncology Hematology
Annapolis, Maryland, 21401
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Minnesota Oncology
Maple Grove, Minnesota, 55369
Siteman Cancer Center - Washington University Medical Campus
St Louis, Missouri, 63110
Nebraska Cancer Specialists
Omaha, Nebraska, 68114
Nebraska Medicine - University of Nebraska Medical Center
Omaha, Nebraska, 68198
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052
Cooper University Health Care
Camden, New Jersey, 08103
New York Oncology Hematology
Albany, New York, 12065
New York-Presbyterian - Columbia University Irving Medical Center
New York, New York, 10032
Stony Brook University Cancer Center
Stony Brook, New York, 11794
Oncology Hematology Care
Cincinnati, Ohio, 45211
Hematology Oncology Associates
Medford, Oregon, 97504
Compass Oncology - Northwest Cancer Specialists
Tigard, Oregon, 97223
Redeemer Health - Holy Redeemer Hospital
Meadowbrook, Pennsylvania, 19046
Sidney Kimmel Comprehensive Cancer Center - Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909
SCRI Oncology Partners
Nashville, Tennessee, 37203
Texas Oncology - Austin
Austin, Texas, 78745
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, 75231
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Baylor College of Medicine - Dan L. Duncan Comprehensive Cancer Center
Houston, Texas, 77057
The University of Texas Health Sciences Center at San Antonio - Mays Cancer Center
San Antonio, Texas, 78229
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, 78240
Texas Oncology - Gulf Coast
Sugar Land, Texas, 77479
Texas Oncology - Tyler
Tyler, Texas, 75702
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Virginia Oncology Associates
Norfolk, Virginia, 23502
Shenandoah Oncology
Winchester, Virginia, 22601