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Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
NCT05498792 · Fox Chase Cancer Center
In plain English
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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
About this study
The primary objectives will be Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.
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
Study design
Enrollment target: 12 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-11-30
Estimated completion: 2026-09-02
Last updated: 2025-04-04
Interventions
Drug: CBL0137Drug: IpilimumabDrug: Nivolumab
Primary outcomes
- • Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab. (28 days)
Sponsor
Fox Chase Cancer Center · other
With: Incuron
Contacts & investigators
ContactAnthony Olszanski, MD · contact · Anthony.Olszanski@fccc.edu · 2152141676
ContactTanu Singh, PhD · contact · Tanu.Singh@fccc.edu · 2152141439
InvestigatorAnthony Olszanski, MD · principal_investigator, Fox Chase Cancer Center
All locations (1)
Fox Chase Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States