drugset / Trial / NCT02334735
A Comparison of Matured Dendritic Cells and Montanide® in Study Subjects With High Risk of Melanoma Recurrence
Phase 2
Completed
36 enrolled
Nina Bhardwaj
Ludwig Institute for Cancer Research · collabMelanoma Research Alliance · collabMemorial Sloan Kettering Cancer Center · collabNYU Langone Health · collabOncovir, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Vaccine adjuvants are compounds used to increase specific immune responses to antigens, but have minimal toxicity or lasting immune effects on their own. This study investigates the use of dendritic cells as an adjuvant for NY-ESO-1 and Melan-A/MART-1 peptides compared to Montanide® in study subjects with melanoma in complete clinical remission.
Timeline
- Start
- 2015-07-01
- Primary completion
- 2020-07-15
- Completion
- 2020-07-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DC vaccine | Vaccine | 100 ug/ml | Other |
| Subject | DC vaccine | Vaccine | 1e+07 cells | Other |
| Subject | DC vaccine | Vaccine | 1.5e+07 cells | Other |
| Comparator | Montanide Vaccine | Vaccine | 250 ug | Subcutaneous |
| Comparator | Montanide Vaccine | Vaccine | 1.1 ml | Subcutaneous |
| Background | Hiltonol | Other / unclassified | 1.4 mg | Subcutaneous |