Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalEarly Phase 1

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

NCT ID: NCT05498792Sponsor: Fox Chase Cancer CenterLast updated: 2026-05-22

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.

Arms & interventions

  • DrugCBL0137

    Patient will be enrolled at 3 dose levels of CBL 0137, dose level -1 (320 mg/m²), dose level 1 (400 mg/m²), dose level 2 (540 mg/m²)

  • DrugIpilimumab

    Patient will be on Ipilimumab (1 mg/kg)

  • DrugNivolumab

    Patient will be on Nivolumab (3 mg/kg)

Outcome measures

Primary

  • Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.

    The primary endpoint will be safety/tolerability of the combination of CBL0137 with ipilimumab and nivolumab. Patients will be treated as part of assigned dose level in planned 3+ 3 design with 3 possible dose levels and assessed for Dose limiting toxicities ( DLTs)

    Time frame: 28 days

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

Recruiting
Anthony J. Olszanski · Contact
215-214-1676Anthony.Olszanski@fccc.edu
Anthony J. Olszanski · Principal Investigator
Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma | Cancerify