Trials / Terminated
TerminatedNCT02425306
Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma
A Trial to Evaluate the Immunogenicity and Safety of a Melanoma Helper Peptide Vaccine Plus Novel Adjuvant Combinations (MEL63)
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Craig L Slingluff, Jr · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates whether it is safe to administer a peptide vaccine in combination with different adjuvants. Adjuvants are substances that may boost immune responses vaccines. In this study, the adjuvants are Montanide ISA-51, polyICLC and cyclophosphamide. This study will also evaluate the effects of the combination of the peptide vaccine and the adjuvants on the immune system. The investigators will monitor these effects by performing tests in the laboratory on participants' blood, a lymph node, and tissue from the sites of vaccination.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 6MHP | 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides |
| DRUG | Montanide ISA-51 | Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant |
| DRUG | polyICLC | polyICLC, local adjuvant |
| DRUG | Cyclophosphamide | Cyclophosphamide, systemic adjuvant |
Timeline
- Start date
- 2015-05-12
- Primary completion
- 2017-08-18
- Completion
- 2018-01-08
- First posted
- 2015-04-23
- Last updated
- 2023-10-30
- Results posted
- 2021-04-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02425306. Inclusion in this directory is not an endorsement.