Combining CBL0137 with Ipilimumab and Nivolumab for Melanoma Treatment

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

This study is testing a new drug called CBL0137 combined with standard melanoma treatments Ipilimumab and Nivolumab to see if it’s safe and helps people with advanced melanoma.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fox Chase Cancer Center (other)
• Drugs / interventions: ipilimumab, nivolumab
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT05498792 on ClinicalTrials.gov

What this trial studies

This early phase 1 clinical trial evaluates the safety and biological activity of CBL0137 when used alongside the standard treatments Ipilimumab and Nivolumab in patients with locally advanced or metastatic melanoma. The study employs a dose-escalation design, allowing researchers to assess the tolerability of the drug combination in adult patients who are candidates for immune checkpoint blockade. Participants will undergo serial biopsies to monitor the effects of the treatment on their tumors. The trial aims to gather initial safety data and determine the potential benefits of this combination therapy.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with stage III or IV melanoma who can undergo repeat biopsies and have normal organ function.

Not a fit: Patients with active autoimmune diseases or those who have previously received certain immunotherapy treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could improve outcomes for patients with advanced melanoma.

How similar studies have performed: Other studies have shown promise with similar immunotherapy combinations, suggesting potential for success in this approach.

Eligibility criteria

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

Where this trial is running

Philadelphia, Pennsylvania

• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Anthony Olszanski, MD — Fox Chase Cancer Center
• Study coordinator: Anthony Olszanski, MD

Conditions: Locally Advanced or Metastatic Melanoma