RECRUITING

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

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Conditions

Locally Advanced or Metastatic Melanoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2022-11-30
Study Completion:2026-09-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05498792

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients must have:
  2. 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:
  3. 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.
  4. 3. Patients must have disease amenable to and must be willing to undergo protocol-directed repeat biopsies and blood draws.
  5. 2. Age \> 18 years
  6. 3. ECOG performance status 0 or 1
  7. 4. Patients must have normal organ and marrow function
  1. 1. Patients may not be receiving any other investigational agents
  2. 2. Patients with a known active autoimmune disease
  3. 3. Prior treatment with CTLA-4 or PD1/PD-L1 pathway targeted systemic treatment
  4. 4. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids
  5. 5. Patients with ongoing diarrhea (\> 4 bowel movements/day) unresolved despite medical and best supportive care in the two weeks preceding therapy

Contacts and Locations

Study Contact

Anthony Olszanski, MD
CONTACT
2152141676
Anthony.Olszanski@fccc.edu
Tanu Singh, PhD
CONTACT
2152141439
Tanu.Singh@fccc.edu

Principal Investigator

Anthony Olszanski, MD
PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center

Study Locations (Sites)

Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States

Collaborators and Investigators

Sponsor: Fox Chase Cancer Center

  • Anthony Olszanski, MD, PRINCIPAL_INVESTIGATOR, Fox Chase Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-30
Study Completion Date2026-09-02

Study Record Updates

Study Start Date2022-11-30
Study Completion Date2026-09-02

Terms related to this study

Additional Relevant MeSH Terms

  • Locally Advanced or Metastatic Melanoma