Phase 1/2 Study of 6MHP Vaccine and Ipilimumab for Advanced Melanoma
Researchers are evaluating whether 6MHP, a peptide vaccine, is safe and efficacious when combined with ipilimumab in patients with stage IIIB or higher melanoma.
Title: A Phase I/II Trial to Evaluate the Safety, Immunogenicity, and Clinical Activity of a Helper Peptide Vaccine Plus CTLA-4 Blockade in Advanced Melanoma (Mel62; 6PAC)1
Principal Investigator: Elizabeth Gaughan, MD, University of Virginia
Study Director: Craig L. Slingluff, Jr, MD, University of Virginia
Description: For this single-arm, open-table, phase 1/2 trial (ClinicalTrials.gov Identifier: NCT02385669), researchers are evaluating whether 6MHP, a peptide vaccine, is safe and efficacious when combined with ipilimumab in patients with stage IIIB or higher melanoma.
6MHP is made up of 6 peptides from melanoma proteins. The vaccine will be delivered intradermally and subcutaneously alongside ipilimumab 3 mg/kg once per 21 days.
The primary endpoints are safety, CD4+ T cell responses, and disease control rate.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02385669.
Status: This study is open and recruiting patients as of August 11, 2017.
This study is sponsored by Craig L Slingluff, Jr.
- Clinicaltrials.gov. A phase I/II trial to evaluate a peptide vaccine plus ipilimumab in patients with melanoma (Mel62; 6PAC). NCT02385669. https://clinicaltrials.gov/ct2/show/NCT02385669. Accessed August 11, 2017.