Back to resultsFLX475 in Combination With Ipilimumab in Advanced Melanoma
Primary Purpose
Advanced Melanoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FLX475
Ipilimumab
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Melanoma focused on measuring Neoplasms, Ipilimumab, Antineoplastic Agents, Immunological
Eligibility 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
Sites / Locations
- University of California, Los Angeles
- Moffitt Cancer Center
- Washington University School of Medicine St. Louis
- The University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FLX475 and ipilimumab combination therapy
Arm Description
Outcomes
Primary Outcome Measures
Safety and tolerability of FLX475 in combination with ipilimumab measured by the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0, including dose-limiting toxicities and serious adverse events.
Overall response rate in subjects treated with FLX475 in combination with ipilimumab
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04894994
Brief Title
FLX475 in Combination With Ipilimumab in Advanced Melanoma
Official Title
Phase 2 Study of FLX475 in Combination With Ipilimumab in Advanced Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Change in clinical landscape
Study Start Date
September 3, 2021 (Actual)
Primary Completion Date
September 13, 2022 (Actual)
Study Completion Date
September 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAPT Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Melanoma
Keywords
Neoplasms, Ipilimumab, Antineoplastic Agents, Immunological
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FLX475 and ipilimumab combination therapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
FLX475
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Safety and tolerability of FLX475 in combination with ipilimumab measured by the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0, including dose-limiting toxicities and serious adverse events.
Time Frame
Approximately 3 weeks
Title
Overall response rate in subjects treated with FLX475 in combination with ipilimumab
Time Frame
Through study completion (approximately 2 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Ho, MD, PhD
Organizational Affiliation
RAPT Therapeutics, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Washington University School of Medicine St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
FLX475 in Combination With Ipilimumab in Advanced Melanoma
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