Actively Recruiting
Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
Led by Fox Chase Cancer Center · Updated on 2025-04-04
12
Participants Needed
1
Research Sites
196 weeks
Total Duration
On this page
Sponsors
F
Fox Chase Cancer Center
Lead Sponsor
I
Incuron
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with pathologically confirmed stage III melanoma with one or more measurable macroscopic lymph node metastases amenable to biopsy or surgery, or patients with stage III or IV disease suitable for serial biopsies
- Willingness to undergo protocol-directed repeat biopsies and blood draws
- Age greater than 18 years
- ECOG performance status of 0 or 1
- Normal organ and marrow function
You will not qualify if you...
- Receiving any other investigational agents
- Known active autoimmune disease
- Prior treatment with CTLA-4 or PD1/PD-L1 pathway targeted systemic treatment
- Concurrent medical conditions requiring immunosuppressive medications or immunosuppressive doses of systemic corticosteroids
- Ongoing unresolved diarrhea with more than 4 bowel movements per day despite medical and supportive care in the two weeks before therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
Research Team
A
Anthony Olszanski, MD
CONTACT
T
Tanu Singh, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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