Regeneron
Name: 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)
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Acronym: Regeneron
Summary & Eligibility:
This study investigates the use of an experimental drug called REGN2810 as a treatment for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
The term “experimental” means that regulatory agencies have not approved REGN2810 to treat this disease. This study is being done to compare the relationship of patient’s response to the experimental treatment to changes in their tumour. Other purposes of this study are to assess the relationship of baseline tumour assessments to the response to REGN2810, to assess the safety and tolerability of REGN2810, and to collect any evidence of anti-tumour activity of REGN2810. Further, it will be explored if there are changes in the blood that may occur after treatment with REGN2810 and how they correspond to patient’s clinical response to REGN2810.
General Inclusion Criteria:
- Histologically confirmed diagnosis of recurrent and/or metastatic SCCHN with no curative options with at least 1 lesion and accessible for biopsies
- Primary tumor sites of oral cavity, oropharynx, larynx, or hypopharynx.
- Failed/are refractory to at least first line chemotherapy OR deemed an unsuitable candidate for first line chemotherapy due to medical co-morbidities or patient preference
- Men and women aged ≥18 years old
- Adequate blood values and liver function
- Ability to provide signed informed consent
General Exclusion Criteria:
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
- Prior treatment with an agent that blocks the PD-1/PD-L1 pathway or any other immune modulating anti-cancer agent
- Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810.
- History of HIV
- Uncontrolled chronic hepatitis B or hepatitis C
- Grade 3 or 4 hypercalcemia at time of enrolment.
- Any systemic anticancer treatment, investigational or standard of care, within 30 days of the initial administration of REGN2810 or planned to occur during the study period
- Known allergy to doxycycline or tetracycline
- Concurrent malignancy other than SCCHN and/or history of malignancy other than with negligible risk of metastasis or death
- Inability to have tumour biopsies due to high safety risks
- Pregnant or breastfeeding women
- Sexually active men or women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose, during the study, and for at least 6 months after the last dose
For full list of inclusion and exclusion criteria please contact the InHANSE team.
Status: Open
Sponsor: Regeneron Pharmaceuticals, Inc.
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