FLX475 in Combination With Ipilimumab in Advanced Melanoma

Study Overview
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Brief Summary
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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.

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

Conditions
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Advanced Melanoma

Intervention / Treatment
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* Drug: FLX475
* Drug: Ipilimumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLX475 and ipilimumab combination therapy<br>Participants received FLX475 tablets orally and ipilimumab by IV infusions | Drug: FLX475<br>* Tablet<br>Drug: Ipilimumab<br>* IV infusion<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasms, Ipilimumab, Antineoplastic Agents, Immunological