Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorFox Chase Cancer Center
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- CBL0137
- Ipilimumab
- Nivolumab
Treatment groups
12 Participants
are divided into 3 treatment groupsSponsors and collaborators
Fox Chase Cancer Center
Lead sponsor
Incuron
Collaborator
Source ClinicalTrials.gov