drugset / Trial / NCT06784648
Different Doses of BI-1607 in Combination With Pembrolizumab and Ipilimumab, in Participants With Unresectable or Metastatic Melanoma
Phase 1/2
Active not recruiting
35 enrolled
BioInvent International AB
Merck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
Why the research is needed: Researchers are looking for a better way to treat melanoma that has spread or cannot be removed surgically. Melanoma is a type of skin cancer that starts in melanocytes, the cells that make the pigment that gives skin its color. In people with cancer, the body cannot control the growth of cells, which can come together to form tumors. This trial's new treatment is called BI-1607. BI-1607 is designed to work by improving the effectiveness of other targeted therapies already used for melanoma treatment; ipilimumab and pembrolizumab. BI-1607 will improve the ability of these two treatments to help the body's defense system to destroy cancer cells.
Timeline
- Start
- 2024-12-11
- Primary completion
- 2025-12-30
- Completion
- 2025-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BI-1607 | Monoclonal antibody | 350 mg | Intravenous |
| Subject | BI-1607 | Monoclonal antibody | 700 mg | Intravenous |
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Ipilimumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |