drugset / Trial / NCT03929029
Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced Melanoma
Phase 1
Active not recruiting
11 enrolled
Dana-Farber Cancer Institute
National Cancer Institute (NCI) · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This research study is investigating a new type of personalized neoantigen vaccine, NeoVax, plus Montanide® in combination with Ipilimumab (Yervoy™) and Nivolumab (Opdivo®) as a possible treatment for cutaneous melanoma. The drugs involved in this study are: * Personalized Neoantigen Vaccine * Poly-ICLC (Hiltonol®) * Montanide® * Ipilimumab (Yervoy™) * Nivolumab (Opdivo®)
Timeline
- Start
- 2020-11-11
- Primary completion
- 2022-12-27
- Completion
- 2028-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 2.5 mg | Subcutaneous |
| Subject | Ipilimumab | Monoclonal antibody | 5 mg | Subcutaneous |
| Subject | NeoVax | Vaccine | — | Other |
| Background | Montanide | Other / unclassified | — | Other |
| Background | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |