Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
gp75 DNA vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 0.1mg |
| 2 | EXPERIMENTAL | 0.5mg |
| 3 | EXPERIMENTAL | 2.0mg |
| 4 | EXPERIMENTAL | 4.0mg |
| 5 | EXPERIMENTAL | 8.0mg |
| Name | Type | Description |
|---|---|---|
| gp75 DNA vaccine | BIOLOGICAL | 6 patients will be enrolled in each of the 5 vaccination groups. Patients in vaccination groups 1-3 will receive a total of 5(1 mL) vaccinations. Patients assigned to vaccination group 4 will receive a total of 5 (2.0 mL) vaccinations administered as 2 1 mL injections. Patients assigned to vaccination group 5 will receive a total of 5 (4.0 mL or 8.0 mg)vaccinations administered as 4 1 mL injections per vaccination treatment Patients will receive gp75 DNA vaccinations every 3 weeks for 5 vaccinations. Injection sites will be given intramuscularly and rotated for each dose using all 4 limbs with the exception of a site that had the removal of lymph nodes. Progression to next higher dose level will be based on the 5\* patient safely completing the 2nd vaccination at the lower dose level. |
Inclusion Criteria: 1. The patient has a diagnosis of American Joint Commission on Cancer (AJCC) stage 111 or IV malignant melanoma. A patient who is free of disease after surgical resection of stage 111 or IV disease, but at high risk (defined as a primary tumor \>4 rnm, satellite or in-transit le...
gp75 DNA vaccine is an investigational vaccine developed by Eli Lilly and Company for malignant melanoma. It was studied in patients with stage III and IV melanoma. It is a vaccine modality, meaning it is intended to stimulate an immune response against the gp75 antigen found on melanoma cells.
gp75 DNA vaccine was studied for the treatment of malignant melanoma, specifically in patients with stage III and IV disease. The single clinical trial enrolled adults 18 years and older of all sexes in the United States. It is not approved for any indication and remains investigational.
Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY, developed gp75 DNA vaccine. The company sponsored the Phase 1 study of the vaccine in patients with stage III and IV melanoma.
gp75 DNA vaccine is in Phase 1 development. It has not been approved by the FDA for any indication. One Phase 1 trial has been completed, and no trials are currently active. The completed study enrolled 31 patients with malignant melanoma.
gp75 DNA vaccine was evaluated in one completed Phase 1 trial, NCT00034554, titled Study of gp75 Vaccine in Patients With Stage III and IV Melanoma. The trial enrolled 31 patients in the United States and included a controlled design. No trials of gp75 DNA vaccine are currently active.