APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma
Summary
You are being asked to take part in this study because you have metastatic (cancer that has spread) melanoma. The goal of Part 1 of this clinical research study is to find the highest tolerable dose of APX005M that can be given with pembrolizumab that can be given to patients with metastatic melanoma. The goal of Part 2 of this study is to learn if the combination can help to control metastatic melanoma. The safety of this drug combination will also be studied. This is an investigational study. APX005M is not FDA approved or commercially available. It is currently being used for research purposes only. Pembrolizumab is FDA approved and commercially available for the treatment of metastatic melanoma. The combination of these drugs to treat metastatic melanoma is investigational. The study doctor can explain how the study drug is designed to work. Up to 41 participants will be treated in this study. All will take part at MD Anderson.
Timeline
- Start
- 2017-06-02
- Primary completion
- 2025-03-10
- Completion
- 2025-03-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | sotigalimab | Monoclonal antibody | 0.1 mg | Other |