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Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

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

NCT05498792•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.

Detailed Description

The primary objectives will be Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients must have:
•1. Pathologically proven stage III melanoma with one or more macroscopic lymph node metastases (measurable according to RECIST v. 1.1) amenable to biopsy and/or surgery OR:
•2. Patients considered to have stage III or stage IV disease amenable to serial biopsies as determined by the treating physician. Note: patients with in-transit metastasis may be eligible after surgical consultation if not surgical candidates.
•3. Patients must have disease amenable to and must be willing to undergo protocol-directed repeat biopsies and blood draws.
•2. Age \> 18 years
•3. ECOG performance status 0 or 1
•4. Patients must have normal organ and marrow function

Exclusion Criteria

•1. Patients may not be receiving any other investigational agents
•2. Patients with a known active autoimmune disease
•3. Prior treatment with CTLA-4 or PD1/PD-L1 pathway targeted systemic treatment
•4. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids
•5. Patients with ongoing diarrhea (\> 4 bowel movements/day) unresolved despite medical and best supportive care in the two weeks preceding therapy

Locations (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

November 30, 2022

Primary Completion Date

March 4, 2026

Completion Date

September 2, 2026

Last Updated

April 4, 2025

Enrollment

ESTIMATED participants

Conditions

Locally Advanced or Metastatic Melanoma

Interventions

CBL0137

DRUG

Ipilimumab

DRUG

Nivolumab

DRUG

Contacts

Anthony Olszanski, MD

CONTACT

2152141676 Anthony.Olszanski@fccc.edu

Tanu Singh, PhD

CONTACT

2152141439 Tanu.Singh@fccc.edu