A Phase 1, Open-Label, Multi-Center, Multi-Dose Study of Intradermal GRN-1201 in HLA-A*02 Subjects with Resected Stage II or III Melanoma

This is a study of an investigational cancer vaccine called GRN-1201. Treatment with the GRN-1201 vaccine is a type of immunotherapy. The goal of immunotherapy is to stimulate the body's immune system (white blood cells) to attack cancer cells and kill them. GRN-1201 consists of 4 different peptides (small parts of proteins) that are expressed by melanoma cells. The intent of treatment with GRN-1201 is to increase your body's immune response to melanoma.

To further increase your body's immune response against tumor cells, the GRN-1201 vaccine will be mixed with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF, also known as sargramostim). GM-CSF is a man-made protein that helps stimulate the immune system and increase the response against the tumor cells. This is a phase I study which means that this will be the first time GRN-1201 is given in combination with GM-CSF to humans. It will be tested in a small number of people to evaluate its safety, find a safe dose, and identify side effects. The safety of GRN-1201 will be tested at three different doses; the GM-CSF dose will remain the same.

Inclusion Criteria:

• Resected, histologically proven, cutaneous melanoma determined to be Stage IIb, IIc, or III; according to the American Joint Commission of Cancer Staging, 7th edition
• Human leukocyte antigen (HLA)-A*02+ by serology by an ASHI accredited laboratory;
Phase I
Cutaneous (skin)
Walter Urba, M.D., Ph.D.
GreenPeptide Co., Ltd.
Chris Fountain
  • Oncology and Hematology Care Eastside