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Clinical Trial 20942

Cancer Type: Cutaneous
Study Type: Treatment
NCT#: NCT04894994

Phase: Phase II
Prinicipal Investigator: Zeynep Eroglu

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Overview

Study Title

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

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.

Objective

1. 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 2. To evaluate the safety and tolerability of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-PD-1 or anti-PD-L1 agent 3.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 4.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 5.To evaluate the objective response rate (ORR), defined as confirmed complete or partial response per iRECIST, of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-PD-1 or anti-PD-L1 agent 6.To evaluate the plasma concentrations of FLX475 when it is given in combination with ipilimumab 7.To assess the effects of FLX475 in combination with ipilimumab on pharmacodynamic (PD) markers relating to drug mechanism of action 8.To characterize the onset, magnitude, and duration of tumor control in subjects receiving FLX475 in combination with ipilimumab

Treatments

Therapies

Medications

FLX475 (); Ipilimumab (); Yervoy (Ipilimumab)

Inclusion 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
  • Other criteria may apply

  • Exclusion Criteria

    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
  • Other criteria may apply

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