FLX475 in Combination With Ipilimumab in Advanced Melanoma

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    20
  • sponsor
    RAPT Therapeutics, Inc.
Updated on 28 June 2022

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.

Details
Condition Advanced Melanoma
Treatment Ipilimumab, FLX475
Clinical Study IdentifierNCT04894994
SponsorRAPT Therapeutics, Inc.
Last Modified on28 June 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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