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Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
Sponsor: Fox Chase Cancer Center
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.
Official title: MEL-212: A Phase I Proof-of-Concept Study of CBL0137 (Curaxin) Combined With Ipilimumab and Nivolumab Therapy in Locally Advanced or Metastatic Melanoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2022-11-30
Completion Date
2026-09-02
Last Updated
2025-04-04
Healthy Volunteers
No
Conditions
Interventions
CBL0137
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)
Ipilimumab
Patient will be on Ipilimumab (1 mg/kg)
Nivolumab
Patient will be on Nivolumab (3 mg/kg)
Locations (1)
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States