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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Health Professionals
What is the purpose of this trial?
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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Principal Investigator
Sub-Investigators
- Adriana Matutino Kahn, MD
- Agatha Hecht
- Alessia Donadio, MD
- Alice Wnuk
- Alison Johnson
- Anca Bulgaru, MD
- Andrea Brennan
- Andrea Silber, MD
- Armand Russo, MD
- Ashita Talsania, MRCP, MBBS
- Benjamin Newton, MD
- Beverly Drucker, MD, PhD
- Christi Kim, MD, FACP
- D. Barry Boyd, MD, MS
- Daniel O'Neil, MD, MPH
- David Witt, MD
- Elan Gorshein, DO, JD, MPH
- Emily Kopas, APRN, OCN
- Eric Winer, MD
- Gineesha Abraham
- Ian Krop, MD, PhD
- Jade Vanacore
- James Vredenburgh, MD
- Jane Kanowitz, MD
- Jason Haldas, MD
- Jeremy Kortmansky, MD
- Johanna LaSala, MD
- Jose Morales-Marin
- Justin Persico, MD
- Karen Ann Hammond, DNP, APRN, ACNP (BC)
- Karishma Mehra, MBBS
- Katherine Harvey, MD, MPH
- Kathleen Fenn, MD
- Kathryn Mason
- Kert Sabbath, MD, FACP
- Kristen Hoxie
- Lajos Pusztai, MD, DPhil
- Laura Sabourin
- Madeline Santiago
- Mariya Rozenblit, MD
- Maryam Lustberg, MD, MPH
- Michael Cohenuram, MD
- Michael Grant, MD
- Michelle Corso
- Neal Fischbach, MD
- Pawan Karanam, MD
- Renee Moye
- Sara Anastasio, RN
- Sarah Carlson
- Sarah Thomen, APRN
- Sarah Elizabeth Schellhorn, MD
- Sharynn Hall, MD, PhD
- Stacey LaRosa
- Stephen Lattanzi, MD
- Su Hsien Lim, MD
- Tara Sanft, MD
- Vanna Dest
- Victor Chang, MD
- Vidya Kesavan
- Virginia Syombathy
- Wajih Kidwai, MD, FACP
- Yifei Zhang, MD
- Zia Rahman, MD
- Last Updated06/13/2024
- Study HIC#2000034374