An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Patients With Head and Neck Cancer 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 microenvironment.

Official Title
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An Exploratory Tumor Biopsy-Driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Immunomodulatory Treatment-Naïve Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck Receiving REGN2810 (Anti-PD-1)

Conditions
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Recurrent Squamous Cell Carcinoma of Head, Recurrent Squamous Cell Carcinoma of Neck, Metastatic Squamous Cell Carcinoma of Head, Metastatic Squamous Cell Carcinoma Neck

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 recurrent and/or metastatic SCCHN (squamous cell carcinoma of the head and neck) with no curative options with at least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and accessible for biopsies. Primary tumor sites of oral cavity, oropharynx, larynx, or hypopharynx are included. Have failed/are refractory to at least first line chemotherapy OR deemed unsuitable candidate for first line chemotherapy due to medical co-morbidities or patient preference Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 Adequate hepatic function Adequate renal function Adequate bone marrow function Provide signed informed consent Willing and able to comply with clinic visits and study-related procedures 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 event (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 Untreated or active brain metastases or spinal cord compression Immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of REGN2810 Prior treatment with idelalisib 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 administered IV over a 30 minute infusion | Drug: REGN2810<br>* Intravenous (IV) use<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. |  | At baseline and during REGN2810 treatment 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 REGN2810 treatment |  | At baseline and during REGN2810 treatment up to week 24 | 
| Number of participants with treatment-related adverse events |  | Up to 54 weeks | 
| Concentrations of REGN2810 in serum |  | Up to 54 weeks | 
| Anti-REGN2810 antibody levels |  | Up to 54 weeks | 
| The overall response rate (ORR) in patients treated with REGN2810 |  | Up to 54 weeks | 
| The progression-free survival (PFS) in patients treated with REGN2810 |  | Up to 54 weeks |