Clinical Trials /

FLX475 in Combination With Ipilimumab in Advanced Melanoma

NCT04894994

Description:

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.

Related Conditions:
  • Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04894994

Trial Eligibility

Document

Title

  • Brief Title: FLX475 in Combination With Ipilimumab in Advanced Melanoma
  • Official Title: Phase 2 Study of FLX475 in Combination With Ipilimumab in Advanced Melanoma

Clinical Trial IDs

  • ORG STUDY ID: FLX475-03
  • NCT ID: NCT04894994

Conditions

  • Advanced Melanoma

Interventions

DrugSynonymsArms
FLX475FLX475 and ipilimumab combination therapy
IpilimumabFLX475 and ipilimumab combination therapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
FLX475 and ipilimumab combination therapyExperimental
  • FLX475
  • Ipilimumab

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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:RAPT Therapeutics, Inc.

Trial Keywords

  • Neoplasms
  • Ipilimumab
  • Antineoplastic Agents
  • Immunological

Last Updated

August 25, 2021