This clinical trial is a Phase 2, open-label study to determine the anti-tumor activity of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed cell death ligand 1 (anti-PD-L1) agent. The study will be conducted starting with a safety run-in portion in which 6 eligible subjects will be enrolled and treated for at least one 3-week cycle to determine if the safety profile of FLX475+ipilimumab is acceptable to complete enrollment of the approximately 20-subject study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Tablet
IV infusion
University of California, Los Angeles
Los Angeles, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Washington University School of Medicine St. Louis
St Louis, Missouri, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Objective Response Rate
To evaluate the objective response rate (ORR), defined as confirmed complete or partial response per RECIST 1.1, of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-PD-1 or anti-PD-L1 agent
Time frame: Approximately 1 year
Safety and Tolerability as Measured by Number of Participants That Experienced Other Adverse Events
Number of participants that experienced Other Adverse Events
Time frame: Approximately 3 weeks
Safety and Tolerability as Measured by Number of Participants That Experienced Serious Adverse Events
Number of participants that experienced Serious Adverse Events
Time frame: Approximately 3 weeks
Progression-free Survival
To evaluate the progression-free survival (PFS) of subjects with advanced melanoma treated with FLX475 in combination with ipilimumab who have been previously treated with an anti-PD-1 or anti-PD-L1 agent
Time frame: Approximately 1 year
Overall Survival (OS)
To evaluate the overall survival (OS) of subjects with advanced melanoma treated with FLX475 in combination with ipilimumab who have been previously treated with an anti-PD-1 or anti-PD-L1 agent
Time frame: Approximately 1 year
Plasma Concentrations of FLX475
To evaluate the plasma concentrations of FLX475 when it is given in combination with ipilimumab
Time frame: Approximately 1 year
Pharmacodynamic (PD) Markers
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To assess the effects of FLX475 in combination with ipilimumab on pharmacodynamic (PD) markers relating to drug mechanism of action
Time frame: Approximately 1 year
Tumor Control
To characterize the onset, magnitude, and duration of tumor control in subjects receiving FLX475 in combination with ipilimumab
Time frame: Approximately 1 year