Study of Cemiplimab and REGN1979 in Patients With Lymphoma
Status:
Active, not recruiting
Trial end date:
2026-08-19
Target enrollment:
Participant gender:
Summary
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