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Trial Title:
Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
NCT ID:
NCT05498792
Condition:
Locally Advanced or Metastatic Melanoma
Conditions: Official terms:
Melanoma
Nivolumab
Ipilimumab
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Suspended
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CBL0137
Description:
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)
Arm group label:
CBL0137 ( Dose level -1) +Ipilimumab + Nivolumab
Arm group label:
CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab
Arm group label:
CBL0137 (Dose level 1) +Ipilimumab + Nivolumab
Other name:
Curaxin
Intervention type:
Drug
Intervention name:
Ipilimumab
Description:
Patient will be on Ipilimumab (1 mg/kg)
Arm group label:
CBL0137 ( Dose level -1) +Ipilimumab + Nivolumab
Arm group label:
CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab
Arm group label:
CBL0137 (Dose level 1) +Ipilimumab + Nivolumab
Intervention type:
Drug
Intervention name:
Nivolumab
Description:
Patient will be on Nivolumab (3 mg/kg)
Arm group label:
CBL0137 ( Dose level -1) +Ipilimumab + Nivolumab
Arm group label:
CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab
Arm group label:
CBL0137 (Dose level 1) +Ipilimumab + Nivolumab
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Start date:
November 30, 2022
Completion date:
September 2, 2025
Lead sponsor:
Agency:
Fox Chase Cancer Center
Agency class:
Other
Collaborator:
Agency:
Incuron
Agency class:
Industry
Source:
Fox Chase Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05498792