FLX475 in Combination With Ipilimumab in Advanced Melanoma
NCT ID: NCT04894994
Last Updated: 2023-12-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
6 participants
INTERVENTIONAL
2021-09-03
2022-09-13
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FLX475 and ipilimumab combination therapy
Participants received FLX475 tablets orally and ipilimumab by IV infusions
FLX475
Tablet
Ipilimumab
IV infusion
Interventions
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FLX475
Tablet
Ipilimumab
IV infusion
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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RAPT Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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William Ho, MD, PhD
Role: STUDY_CHAIR
RAPT Therapeutics, Inc.
Locations
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University of California, Los Angeles
Los Angeles, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Washington University School of Medicine St. Louis
St Louis, Missouri, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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FLX475-03
Identifier Type: -
Identifier Source: org_study_id