Combining CBL0137 with Ipilimumab and Nivolumab for Melanoma Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: Anthony.Olszanski@fccc.edu
• Phone: 2152141676

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.