Locally Advanced or Metastatic Melanoma
Conditions
Brief 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.
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)
Sponsors
Fox Chase Cancer Center
Incuron
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab. | 28 days | 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) |
Countries
United States
Contacts
CONTACTAnthony Olszanski, MD
CONTACTTanu Singh, PhD
PRINCIPAL_INVESTIGATORAnthony Olszanski, MD
Fox Chase Cancer Center
Outcome results
None listed