A Phase I/II Trial to Evaluate a Peptide Vaccine Plus Ipilimumab in Patients With Melanoma

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
Craig L Slingluff, Jr
Study ID
NCT02385669
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    Checkpoint blockade inhibitor
  • 6MHP — BIOLOGICAL
    6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides

Study Details

This study evaluates whether it is safe to administer a peptide vaccine with ipilimumab. This study will also evaluate the effects of the combination of the peptide vaccine and ipilimumab on the immune system. The investigators will monitor these effects by performing tests in the laboratory on participants' blood, a lymph node, and tumor samples.

Key Dates

Start date
Apr 30, 2015
Status verified
Apr 2020
Primary completion
Sep 18, 2019
Completion
Sep 18, 2019

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 6MHP and ipilimumab
    The vaccine drug product, 6MHP, consists of 6 class II MHC-restricted peptides derived from melanoma proteins. Each vaccine consists of 200 mcg of each of the six peptides. An aqueous solution of vaccine is mixed 1/1 with Montanide ISA-51 to form water-in-oil emulsions. Vaccines are administered days 1, 8, 15, 43, 64, and 85. All peptide vaccines are administered intradermally and subcutaneously. Ipilimumab will be administered in accord with the official prescribing information: 3 mg/kg intravenously once every 3 weeks, for 4 doses. Ipilimumab will be administered on days 1, 22, 43, and 64.

Primary Outcome Measure

Safety (Adverse Event Profile) [ Time Frame: 30 days after the last vaccination ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cancer Center at the University of VirginiaCharlottesvilleVirginia22908-

Find similar trials in Charlottesville, VA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Cancer Center at the University of Virginia· Charlottesville, VA

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