RecruitingEarly Phase 1NCT05498792

Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma

MEL-212: A Phase I Proof-of-Concept Study of CBL0137 (Curaxin) Combined With Ipilimumab and Nivolumab Therapy in Locally Advanced or Metastatic Melanoma

Sponsor

Fox Chase Cancer Center

Enrollment

12 participants

Start Date

Nov 30, 2022

Study Type

INTERVENTIONAL

Conditions

Locally Advanced or Metastatic Melanoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of an experimental drug (CBL0137) with two established immunotherapy drugs (ipilimumab and nivolumab) in patients with advanced melanoma skin cancer. CBL0137 works by activating the immune system and targeting proteins that help cancer cells survive. **You may be eligible if...** - You are over 18 with stage III or IV melanoma - Your cancer can be biopsied and/or surgically removed - You have good overall health (ECOG performance status 0 or 1) - Your organ function (liver, kidneys, bone marrow) is within normal limits **You may NOT be eligible if...** - You are currently on other investigational treatments - You have active autoimmune disease requiring treatment - You have had a prior organ transplant - Your cancer has spread to the brain and is not being treated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCBL0137

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)

DRUGIpilimumab

Patient will be on Ipilimumab (1 mg/kg)

DRUGNivolumab

Patient will be on Nivolumab (3 mg/kg)

Locations(1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05498792