FLX475 in Combination With Ipilimumab in Advanced Melanoma

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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-PD-1 or 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RAPT Therapeutics, Inc.
• Treatments: Ipilimumab

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 CTLA-4 antagonists