An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Melanoma Patients Receiving REGN2810 (Anti-PD-1)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Regeneron Pharmaceuticals
With
Sanofi
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Melanoma Patients Receiving REGN2810 (Anti-PD-1)
