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RECRUITING
NCT05498792
EARLY_PHASE1

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

Sponsor: Fox Chase Cancer Center

View on ClinicalTrials.gov

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

Interventions

DRUG

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)

DRUG

Ipilimumab

Patient will be on Ipilimumab (1 mg/kg)

DRUG

Nivolumab

Patient will be on Nivolumab (3 mg/kg)

Locations (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States