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

• Status: Completed
• Trial end date: 2020-03-19
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: Sanofi
• Treatments: Cemiplimab

Criteria

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