FLX475 in Combination With Ipilimumab in Advanced Melanoma

Advanced Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04894994
• Other study ID #: FLX475-03
• Status: Terminated
• Phase: Phase 2
• Start date: September 3, 2021
• Est. completion date: September 13, 2022

Study information

• Verified date: December 2023
• Source: RAPT Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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-programmed cell death 1 (anti-PD-1) or anti-programmed cell death ligand 1 (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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 13, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (cytotoxic T-lymphocyte-associated antigen 4) CTLA-4 antagonists

Related Conditions & MeSH terms

• Advanced Melanoma
• Melanoma

Intervention

Drug:
• FLX475
Tablet
• Ipilimumab
IV infusion

Locations

Country	Name	City	State
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of California, Los Angeles	Los Angeles	California
United States	Washington University School of Medicine St. Louis	Saint Louis	Missouri
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
RAPT Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	To evaluate the objective response rate (ORR), defined as confirmed complete or partial response per RECIST 1.1, of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-PD-1 or anti-PD-L1 agent	Approximately 1 year
Primary	Safety and Tolerability as Measured by Number of Participants That Experienced Other Adverse Events	Number of participants that experienced Other Adverse Events	Approximately 3 weeks
Primary	Safety and Tolerability as Measured by Number of Participants That Experienced Serious Adverse Events	Number of participants that experienced Serious Adverse Events	Approximately 3 weeks
Secondary	Progression-free Survival	To evaluate the progression-free survival (PFS) of subjects with advanced melanoma treated with FLX475 in combination with ipilimumab who have been previously treated with an anti-PD-1 or anti-PD-L1 agent	Approximately 1 year
Secondary	Overall Survival (OS)	To evaluate the overall survival (OS) of subjects with advanced melanoma treated with FLX475 in combination with ipilimumab who have been previously treated with an anti-PD-1 or anti-PD-L1 agent	Approximately 1 year
Secondary	Plasma Concentrations of FLX475	To evaluate the plasma concentrations of FLX475 when it is given in combination with ipilimumab	Approximately 1 year
Secondary	Pharmacodynamic (PD) Markers	To assess the effects of FLX475 in combination with ipilimumab on pharmacodynamic (PD) markers relating to drug mechanism of action	Approximately 1 year
Secondary	Tumor Control	To characterize the onset, magnitude, and duration of tumor control in subjects receiving FLX475 in combination with ipilimumab	Approximately 1 year