FLX475 in Combination With Ipilimumab in Advanced Melanoma

NCT04894994 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: FLX475-03
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 4

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-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.

Conditions

Advanced Melanoma

Keywords

Neoplasms; Ipilimumab; Antineoplastic Agents; Immunological

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Progression-free Survival

  Approximately 1 year

• Overall Survival (OS)

  Approximately 1 year

• Plasma Concentrations of FLX475

  Approximately 1 year

• Pharmacodynamic (PD) Markers

  Approximately 1 year

• Tumor Control

  Approximately 1 year

Study Arms (1)

FLX475 and ipilimumab combination therapy

EXPERIMENTAL

Participants received FLX475 tablets orally and ipilimumab by IV infusions

Drug: FLX475; Drug: Ipilimumab

Interventions

FLX475 DRUG

Tablet

FLX475 and ipilimumab combination therapy

Ipilimumab DRUG

IV infusion

FLX475 and ipilimumab combination therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RAPT Therapeutics, Inc.: lead

Study Sites (4)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Washington University School of Medicine St. Louis

St Louis, Missouri, 63110, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Ipilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

The study was terminated early due to changes in the treatment landscape of melanoma that have occurred since the initiation of the study, leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: William Ho
• Organization: RAPT Therapeutics

bill.ho@RAPT.com

650-489-9037

Study Officials

• William Ho, MD, PhD

  RAPT Therapeutics, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 20, 2021
• Study Start: September 3, 2021
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: December 5, 2023
• Results First Posted: December 5, 2023

Record last verified: 2023-12

Locations

US (4)