Last reviewed · How we verify
A TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A HELPER PEPTIDE VACCINE PLUS COMBINATION OF BRAF INHIBITION AND MEK INHIBITION (MEL61) (Mel61)
This study evaluates whether it is safe to administer a helper peptide vaccine with BRAF inhibitor and MEK inhibitor therapy. This study will also evaluate the effects of the combination of the peptide vaccine and BRAF inhibitors/MEK inhibitors on the immune system. We will monitor these effects by performing tests in the laboratory on participants' blood and tumor samples.
Details
| Lead sponsor | Craig L Slingluff, Jr |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | TERMINATED |
| Enrolment | 8 |
| Start date | 2016-04 |
| Completion | 2022-02-28 |
Conditions
- Melanoma
Interventions
- BRAF inhibitor
- 6MHP
- MEK inhibitor
Primary outcomes
- Adverse event profile for the combination of BRAFi, MEKi, and 6MHP — 30 days after the last vaccination with 6MHP
- CD4+ T cell responses in the blood — through day 85
CD4+ T cell responses to the peptide vaccine
Countries
United States