Phase 2 Study of Axitinib + Ipilimumab in Advanced Melanoma
H. Lee Moffitt Cancer Center and Research Institute
Summary
The goal of this clinical research study is to find out if taking axitinib with ipilimumab is effective in treating advanced melanoma.
Description
The safety and tolerability of the combination of ipilimumab and axitinib will be tested in advanced melanoma patients who are intolerable/refractory to anti-PD-1/PD-L1 therapy and have not previously received treatment with ipilimumab.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of advanced/unresectable melanoma - uveal melanoma is excluded * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Adequate bone marrow, organ function and laboratory parameters as defined in protocol. * Patients must have adequately controlled blood pressure (\<150 systolic and \<100 diastolic) * At least 1 measurable lesion - per irRECIST 1.1 criteria * Documented disease refractory or intolerant to anti-PD-1/PD-L1 inhibitor treatment: in the metastatic setting or in the adjuvant setting if relapse on or within 6 months from end of anti-PD-1…
Interventions
- DrugIpilimumab
Participants will receive ipilimumab 3mg/kg IV every 3 weeks for up to 4 doses.
- DrugAxitinib
Participants will take 5 mg Axitinib twice daily by mouth for up to 35 cycles (24 months)
Location
- Moffitt Cancer CenterTampa, Florida