Open Actively Recruiting

FLX475 in Combination With Ipilimumab in Advanced Melanoma

About

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-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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

Join this Trial

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Study Stats
Protocol No.
21-000371
Category
Hematology-Oncology
Oncology
Contact
Elizabeth Seja
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04894994
For detailed technical eligibility, visit ClinicalTrials.gov.