Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects (FLAMINGO-01)
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)
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Clinical Trial Information
Trial Contact: Durand, Jennifer; Ribacchi, Stephanie; Casillas, Bridey L
Trial Phone: 321.843.2026 ; 321-841-1077 ; 321.841.8284
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IRB No: WCG 20216029
Protocol Abbrev: TRIO-FLAMINGO-01
Principal Investigator: Nikita Chandrakant Shah, MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: GLSI-21-01, GLSI-100
Treatment: Arm1: Placebo, 0.9% Normal Saline Arm2: GLSI-100, 500mcg/mL GP2 and 125 mcg/mL GM-CSF Arm 3: small open label arm GLSI-100, 500mcg/mL GP2 and 125 mcg/mL GM-CSF
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT05232916
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Objective
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.
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Key Eligibility
-18 to 100 years old
-HLA-A*02-positive, unless being enrolled in the third non-HLA-A*02 arm
-Histologically confirmed diagnosis of HER2/neu positive primary breast cancer
-Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer therapy
-Stage I, II, or III at presentation with pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes (residual disease) at surgery following completion of neoadjuvant therapy -OR- Stage III at presentation with pathologic complete response (pCR) at surgery following completion of neoadjuvant therapy
-The subject can begin study therapy within 90 days of completion of adjuvant trastuzumab-based therapy and any other standard therapies, but study therapy can be administered concurrently with endocrine therapy.
-No clinical evidence of residual or persistent breast cancer per treating physician assessment
-ECOG 0-2
-Adequate organ function
-Negative pregnancy test or evidence of post-menopausal status
-If of childbearing potential, willing to use a form of highly effective contraception
