Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

Phase 2 Study of FLX475 in Combination With Ipilimumab in Advanced Melanoma

Keywords

Advanced Melanoma Neoplasms Ipilimumab Antineoplastic Agents Immunological Melanoma FLX475

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • The University of Texas MD Anderson Cancer Center not yet accepting patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
RAPT Therapeutics, Inc.
ID
NCT04894994
Phase
Phase 2
Study Type
Interventional
Last Updated