drugset / Trial / NCT05498792
Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Phase I, open label, dose-escalation, and safety study designed to assess the safety and biologic activity of the investigational agent CBL0137 in combination with standard of care drugs, ipilimumab and nivolumab in sequential cohorts of adult patients with locally advanced and metastatic melanoma who are candidates for immune checkpoint blockade and have tumors accessible for serial biopsies.
Timeline
- Start
- 2022-11-30
- Primary completion
- 2027-03-04
- Completion
- 2027-09-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Patient will be enrolled at 3 dose levels of CBL 0137, dose level -1 (320 mg/m²), dose level 1 (400 mg/m²), dose level 2 (540 mg/m²) | Unknown | 320 mg/m2 | Intravenous |
| Subject | Patient will be enrolled at 3 dose levels of CBL 0137, dose level -1 (320 mg/m²), dose level 1 (400 mg/m²), dose level 2 (540 mg/m²) | Unknown | 400 mg/m2 | Intravenous |
| Subject | Patient will be enrolled at 3 dose levels of CBL 0137, dose level -1 (320 mg/m²), dose level 1 (400 mg/m²), dose level 2 (540 mg/m²) | Unknown | 540 mg/m2 | Intravenous |