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FLX475 in Combination With Ipilimumab in Advanced Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04894994
Recruitment Status : Recruiting
First Posted : May 20, 2021
Last Update Posted : June 14, 2022
Sponsor:
Information provided by (Responsible Party):
RAPT Therapeutics, Inc.

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.


Condition or disease Intervention/treatment Phase
Advanced Melanoma Drug: FLX475 Drug: Ipilimumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of FLX475 in Combination With Ipilimumab in Advanced Melanoma
Actual Study Start Date : September 3, 2021
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Ipilimumab

Arm Intervention/treatment
Experimental: FLX475 and ipilimumab combination therapy Drug: FLX475
Tablet

Drug: Ipilimumab
IV infusion




Primary Outcome Measures :
  1. 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 ]
  2. Overall response rate in subjects treated with FLX475 in combination with ipilimumab [ Time Frame: Through study completion (approximately 2 years) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04894994


Contacts
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Contact: Clinical Trial Manager 650-489-9019 clinical.trials@rapt.com

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Elizabeth Seja    310-794-6892    eseja@mednet.ucla.edu   
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Marjorie Colon-Colon       marjorie.coloncolon@moffitt.com   
United States, Missouri
Washington University School of Medicine St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Grayson Talcott    314-273-0656    wu-grayson@wustl.edu   
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lauren Simpson    713-792-2921      
Sponsors and Collaborators
RAPT Therapeutics, Inc.
Investigators
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Study Chair: William Ho, MD, PhD RAPT Therapeutics, Inc.
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Responsible Party: RAPT Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04894994    
Other Study ID Numbers: FLX475-03
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RAPT Therapeutics, Inc.:
Neoplasms
Ipilimumab
Antineoplastic Agents
Immunological
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action