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History of Changes for Study: NCT05232916
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)
Latest version (submitted May 2, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 31, 2022 None (earliest Version on record)
2 February 13, 2022 Study Status, Outcome Measures and Contacts/Locations
3 June 24, 2022 Contacts/Locations, Study Status and Arms and Interventions
4 August 16, 2022 Recruitment Status, Contacts/Locations and Study Status
5 September 1, 2022 Contacts/Locations and Study Status
6 September 14, 2022 Contacts/Locations and Study Status
7 September 30, 2022 Contacts/Locations and Study Status
8 November 1, 2022 Study Status and Contacts/Locations
9 November 16, 2022 Contacts/Locations and Study Status
10 December 15, 2022 Contacts/Locations and Study Status
11 January 11, 2023 Contacts/Locations and Study Status
12 January 30, 2023 Contacts/Locations and Study Status
13 February 27, 2023 Contacts/Locations and Study Status
14 April 7, 2023 Contacts/Locations, Study Status and Eligibility
15 May 30, 2023 Contacts/Locations, Study Status and Arms and Interventions
16 June 6, 2023 Contacts/Locations, Study Status and Arms and Interventions
17 June 9, 2023 Contacts/Locations and Study Status
18 June 23, 2023 Contacts/Locations and Study Status
19 July 17, 2023 Contacts/Locations and Study Status
20 July 24, 2023 Study Status and Contacts/Locations
21 November 3, 2023 Contacts/Locations and Study Status
22 December 4, 2023 Study Status and Contacts/Locations
23 December 18, 2023 Contacts/Locations and Study Status
24 January 12, 2024 Study Status and Contacts/Locations
25 March 4, 2024 Contacts/Locations and Study Status
26 March 7, 2024 Contacts/Locations and Study Status
27 March 11, 2024 Contacts/Locations and Study Status
28 May 2, 2024 Contacts/Locations and Study Status
Comparison Format:
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Study NCT05232916
Submitted Date:  January 31, 2022 (v1)
Open or close this module Study Identification
Unique Protocol ID: GLSI-21-01
Brief Title: 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)
Official Title: 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)
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2022
Overall Status: Not yet recruiting
Study Start: March 2022
Primary Completion: December 2027 [Anticipated]
Study Completion: December 2027 [Anticipated]
First Submitted: January 31, 2022
First Submitted that
Met QC Criteria:		 January 31, 2022
First Posted: February 10, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:		 January 31, 2022
Last Update Posted: February 10, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Greenwich LifeSciences, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief 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.
Detailed Description:
Open or close this module Conditions
Conditions: Breast Cancer
Keywords: HER2/neu positive
Residual disease
pCR
Extended adjuvant
GP2
Immunotherapy
HLA type
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
HLA-A*02 subjects will be randomized to GLSI-100 or placebo. 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.
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 598 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo Comparator: 0.9% Normal Saline

0.9% normal saline in HLA-A*02 positive and HER2/neu positive subjects

1 mL 0.9% normal saline intradermally, every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years)

 Biological: Placebo
0.9% Normal Saline
Experimental: GLSI-100

GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects

1 mL GLSI-100 intradermally, every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years)

 Biological: GLSI-100
500 mcg/mL GP2 and 125 mcg/mL GM-CSF
Experimental: GLSI-100, Open-label

Small, open-label arm: GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects

1 mL GLSI-100 intradermally, every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years)

 Biological: GLSI-100
500 mcg/mL GP2 and 125 mcg/mL GM-CSF
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Invasive Breast Cancer-free Survival (IBCFS)
[ Time Frame: Over 4 years of follow-up ]

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.
Secondary Outcome Measures:
1. Invasive Disease-free Survival (IDFS)
[ Time Frame: Over 4 years of follow-up ]

IDFS 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, second primary non-breast invasive cancer, or any cause mortality.
2. Distant Disease-free Survival (DDFS)
[ Time Frame: Over 4 years of follow-up ]

DDFS will be defined as the time from the first dose of study medication to the time of distant disease recurrence or death.
3. Overall Survival
[ Time Frame: Over 4 years of follow-up ]

Overall survival will be defined as the time from the first dose of study medication until death from any cause.
4. Quality of Life Questionnaire Core 30 (QLQ-C30)
[ Time Frame: Baseline and 36 months ]

European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
5. Quality of Life FACT-GP5
[ Time Frame: Baseline and 36 months ]

FACT-GP5 to assess global side effect impact
Other Outcome Measures:
1. Immune Response Measurements
[ Time Frame: Screening, Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12, Month 13, Month 18, Month 19, Month 24, Month 25, Month 30, Month 31, Month 36, Month 37, Month 42, Month 48 ]

Immune response will be measured by Delayed-Type Hypersensitivity (DTH) tests and immunologic assays.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 100 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Stage IV cancer or metastatic breast cancer at any time
  • Inflammatory breast cancer
  • Receiving other investigational agents
  • Receiving chemotherapy
  • Requiring systemic treatment with corticosteroids or other immunosuppressive therapy
  • History of immunodeficiency or active autoimmune disease
  • A history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony-stimulating factors such as sargramostim, yeast-derived products, or any component of the investigational product
  • Other malignancies except adequately treated in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
  • Active infection
  • Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment. Note: Subjects on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.
Open or close this module Contacts/Locations
Central Contact Person: Jaye L Thompson, Ph.D.
Telephone: (832) 819-3232
Email: Jaye.Thompson@GreenwichLifeSciences.com
Study Officials: Mothaffar F Rimawi, MD
Principal Investigator
Baylor College of Medicine
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services