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

Description

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.

Conditions

Locally Advanced or Metastatic Melanoma

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Study Overview

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Study Details

Study overview

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.

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 of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma

Condition
Locally Advanced or Metastatic Melanoma
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States, 19111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Fox Chase Cancer Center,

Anthony Olszanski, MD, PRINCIPAL_INVESTIGATOR, Fox Chase Cancer Center

Study Record Dates

2026-09-02