Safety Study of a Helper Peptide Vaccine Plus Pembrolizumab (Mel64;PATHVACS)
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|ClinicalTrials.gov Identifier: NCT02515227|
Recruitment Status : Recruiting
First Posted : August 4, 2015
Last Update Posted : January 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: 6MHP Drug: Pembrolizumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Trial to Evaluate the Safety, Immunogenicity, and Clinical Activity of a Helper Peptide Vaccine Plus PD-1 Blockade|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2021|
Experimental: 6MHP + Pembrolizumab
6 MHP (200 mcg each peptide) will be administered intradermally and subcutaneously on days 1, 8, 15, 43, 64, and 85. Pembrolizumab (200 mg) will be administered intravenously every 3 weeks for up to 2 years, beginning on day 1.
6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Other Name: 6 melanoma helper peptide vaccine
Humanized monoclonal antibody (mAb) specific for PD-1.
- Adverse event profile for the combination of pembrolizumab and 6MHP. [ Time Frame: 30 days after the last administration of study drug. ]
- CD4+ T cell responses in the blood and in the sentinel immunized node [ Time Frame: through week 104 ]Measurements of CD4+ T cell responses to the peptide vaccine.
- Number of T cells in the tumor microenvironment [ Time Frame: up to week 104 ]Evaluation of tumor infiltration by CD4+ and CD8+ T cells.
- Level of Th1-dominant immune signatures in the tumor microenvironment [ Time Frame: up to week 104 ]Evaluation of cytokine profile for CD4+ T cells.
- Number of CD8+ T cell responses to defined melanoma antigens [ Time Frame: up to week 104 ]Evaluation of epitope-spreading through the measurement of the induction of CD8+ T cell responses to defined melanoma antigens.
- Amount of IgG antibody specific for 6MHP as measured in the blood and the sentinel immunized node [ Time Frame: up to week 104 ]Evaluation of antibody responses to 6MHP
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02515227
|Contact: Jessica Zareno, MSfirstname.lastname@example.org|
|Contact: Meagan Darlingemail@example.com|
|United States, Virginia|
|University of Virginia Cancer Center||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Craig L. Slingluff, MD 434-924-1730 firstname.lastname@example.org|
|Contact: Jessica Zareno, MS 434-982-1901 email@example.com|
|Principal Investigator: Craig L. Slingluff, MD|
|Study Director:||Craig L. Slingluff, Jr., MD||University of Virginia|