Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CBL0137, Ipilimumab, Nivolumab.
- Who it may be relevant to
- Registry conditions: Locally Advanced or Metastatic Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
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.
Detailed description
The primary objectives will be Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.
Interventions
- Drug CBL0137
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) - Drug Ipilimumab
Patient will be on Ipilimumab (1 mg/kg) - Drug Nivolumab
Patient will be on Nivolumab (3 mg/kg)
Primary outcome measures
- Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab. [Time frame: 28 days]
Eligibility criteria
Inclusion criteria
- Patients must have:
- 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:
- 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.
- Patients must have disease amenable to and must be willing to undergo protocol-directed repeat biopsies and blood draws.
- Age > 18 years
- ECOG performance status 0 or 1
- Patients must have normal organ and marrow function
Exclusion criteria
- Patients may not be receiving any other investigational agents
- Patients with a known active autoimmune disease
- Prior treatment with CTLA-4 or PD1/PD-L1 pathway targeted systemic treatment
- Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids
- Patients with ongoing diarrhea (> 4 bowel movements/day) unresolved despite medical and best supportive care in the two weeks preceding therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Fox Chase Cancer Center — Philadelphia
Identifiers
NCT: NCT05498792 · MEL-212 · 22-1028