An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Melanoma Patients Receiving REGN2810 (Anti-PD-1)

Study Overview
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Brief Summary
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This study is being conducted to compare the relationship of patient response to treatment to changes in tumor environment.

Official Title
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An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Indicators of Clinical Response in Immunomodulatory Treatment-naïve Unresectable Stage III/IV Melanoma Patients Receiving REGN2810 (Anti-PD-1)

Conditions
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Melanoma

Intervention / Treatment
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* Drug: REGN2810


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Histologically confirmed diagnosis of stage III (unresectable) or stage IV cutaneous melanoma (non-acral lentiginous) with at least 1 lesion that is measurable by RECIST 1.1 criteria and accessible for biopsies Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 Adequate hepatic function Adequate renal function Adequate bone marrow function Willing and able to comply with clinic visits and study-related procedures Provide signed informed consent Able to understand and complete study-related questionnaires Anticipated life expectancy >12 weeks Key Exclusion Criteria: Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway) Prior treatment with other immune modulating anti-cancer agents, except for remote treatment (>6 months) in adjuvant setting. Untreated or active brain metastases or spinal cord compression Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810 Other protocol-defined inclusion/exclusion criteria will apply

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: REGN2810<br>REGN2810 treatment | Drug: REGN2810<br>* REGN2810 treatment<br>* Other names: Libtayo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline |  | Baseline up to week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between baseline tumor characteristics and the change in tumor volume following treatment in REGN2810 |  | Baseline up to week 24 | 
| Incidence of Adverse Event (AEs) in patients treated with REGN2810 |  | Baseline through treatment with REGN2810 (up to 48 weeks) and follow up | 
| REGN2810 serum concentrations |  | Baseline up to 6 weeks following last dose of REGN2810 | 
| Anti-REGN2810 antibody levels |  | Baseline up to 6 weeks following last dose of REGN2810 | 
| The progression-free survival (PFS) in patients treated with REGN2810 |  | Baseline up to 6 weeks following last dose of REGN2810 | 
| The overall response rate in patients treated with REGN2810 |  | Baseline up to 6 weeks following last dose of REGN2810 |