FLX475 in Combination With Ipilimumab in Advanced Melanoma
- Registration Number
- NCT04894994
- Lead Sponsor
- RAPT Therapeutics, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
- Stage IV or unresectable Stage III advanced melanoma
- Prior treatment with at least 2 months of anti-PD-(L)1 agent
- Measurable disease at baseline
- Tumor available for biopsy
- History of allergy or severe hypersensitivity to biologic agents
- History of Grade 3-4 immune-related adverse events leading to discontinuation of prior immunotherapy
- Prior treatment with ipilimumab or other (cytotoxic T-lymphocyte-associated antigen 4) CTLA-4 antagonists
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FLX475 and ipilimumab combination therapy FLX475 Participants received FLX475 tablets orally and ipilimumab by IV infusions FLX475 and ipilimumab combination therapy Ipilimumab Participants received FLX475 tablets orally and ipilimumab by IV infusions
- Primary Outcome Measures
Name Time Method Objective Response Rate Approximately 1 year 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
Safety and Tolerability as Measured by Number of Participants That Experienced Other Adverse Events Approximately 3 weeks Number of participants that experienced Other Adverse Events
Safety and Tolerability as Measured by Number of Participants That Experienced Serious Adverse Events Approximately 3 weeks Number of participants that experienced Serious Adverse Events
- Secondary Outcome Measures
Name Time Method Progression-free Survival Approximately 1 year 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
Overall Survival (OS) Approximately 1 year 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
Plasma Concentrations of FLX475 Approximately 1 year To evaluate the plasma concentrations of FLX475 when it is given in combination with ipilimumab
Pharmacodynamic (PD) Markers Approximately 1 year To assess the effects of FLX475 in combination with ipilimumab on pharmacodynamic (PD) markers relating to drug mechanism of action
Tumor Control Approximately 1 year To characterize the onset, magnitude, and duration of tumor control in subjects receiving FLX475 in combination with ipilimumab
Trial Locations
- Locations (4)
Washington University School of Medicine St. Louis
🇺🇸Saint Louis, Missouri, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States