Last updated on November 2019

Study of Cemiplimab and REGN1979 in Patients With Lymphoma


Brief description of study

This is an open-label, multicenter, dose escalation study of cemiplimab and REGN1979 in patients with lymphoma. The study treatment period will be from 6 to 12 months, depending on how an individual patient responds to treatment. The follow-up period will be 6 months for all patients.

The primary objective of the study is to assess safety, tolerability and dose-limiting toxicity (DLT) of:

  • Single-agent cemiplimab in patients with lymphoma (B-NHL and HL)
  • Combination REGN1979 and cemiplimab in patients with B-NHL

The secondary objectives of the study are:

  • To determine a recommended dose for:
  • Cemiplimab as a single-agent in patients with lymphoma (B-NHL and HL)
  • REGN1979 and cemiplimab administered in combination in patients with B-NHL
  • To characterize the pharmacokinetic (PK) profile of cemiplimab when administered as a single agent and of cemiplimab and REGN1979 when administered in combination
  • To assess the immunogenicity of cemiplimab when administered alone and the immunogenicity of cemiplimab and REGN1979 when administered in combination
  • To study the preliminary antitumor activity of cemiplimab as a single agent and of the combination of cemiplimab and REGN1979 in specific indications, as measured by overall response rate, MRD in patients with bone marrow disease at baseline, duration of response, and median progression-free survival and rates at 6 and 12 months

Clinical Study Identifier: NCT02651662

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