FLX475 in Combination With Ipilimumab in Advanced Melanoma

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

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.

Study Overview

• Status: Terminated
• Conditions: Advanced Melanoma
• Intervention / Treatment: Drug: FLX475; Drug: Ipilimumab

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine St. Louis
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FLX475 and ipilimumab combination therapy; Participants received FLX475 tablets orally and ipilimumab by IV infusions	Drug: FLX475; Tablet; Drug: Ipilimumab; IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Plasma Concentrations of FLX475	To evaluate the plasma concentrations of FLX475 when it is given in combination with ipilimumab	Approximately 1 year
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
Tumor Control	To characterize the onset, magnitude, and duration of tumor control in subjects receiving FLX475 in combination with ipilimumab	Approximately 1 year

Collaborators and Investigators

• Sponsor: RAPT Therapeutics, Inc.
• Investigators: Study Chair: William Ho, MD, PhD, RAPT Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2021
• Primary Completion (Actual): September 13, 2022
• Study Completion (Actual): September 13, 2022

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Neoplasms; Ipilimumab; Antineoplastic Agents; Immunological
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Ipilimumab
• Other Study ID Numbers: FLX475-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No