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Brief Title: Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
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
Study ID: NCT05498792
Brief 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.
Detailed Description: The primary objectives will be Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Name: Anthony Olszanski, MD
Affiliation: Fox Chase Cancer Center
Role: PRINCIPAL_INVESTIGATOR