Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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

Official Title

A Phase 1 Study to Assess Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, and REGN2810, an Anti-Programmed Death-1 Monoclonal Antibody, in Patients With B-Cell Malignancies

Keywords

Lymphoma Cemiplimab REGN1979 Open label (cemiplimab) Open label (cemiplimab and REGN1979)

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Have documented CD20+ B-cell NHL or documented HL, with active disease that is either not responsive to or relapsed after prior therapy, for whom no standard of care options exists.
  2. Must have at least 1 bi-dimensionally measurable lesion (≥1.5 cm) documented by diagnostic imaging (CT, PET-CT or MRI).
  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  4. Life expectancy of at least 6 months
  5. Adequate bone marrow function
  6. Adequate organ function
  7. Willing and able to comply with clinic visits and study-related procedures
  8. Provide signed informed consent

You CAN'T join if...

(NHL and HL):

  1. Primary central nervous system (CNS) lymphoma, or known or suspected CNS involvement by nonprimary CNS NHL
  2. History of or current relevant CNS pathology
  3. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for iAEs
  4. Prior allogeneic stem cell transplantation
  5. Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway), unless benefit was demonstrated
  6. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection or other uncontrolled infection
  7. History of hypersensitivity to any compound in the tetracycline antibiotics group
  8. Known hypersensitivity to both allopurinol and rasburicase
  9. Pregnant or breastfeeding women
  10. . Continued sexual activity in men or women of childbearing potential who are unwilling to practice adequate contraception during the study
  11. . Prior treatment with idelalisib

Note: Other protocol Inclusion/Exclusion criteria apply

Locations

  • Regeneron Research Facility
    Santa Monica California 90404 United States
  • Regeneron Research Facility
    San Antonio Texas 78229 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT02651662
Phase
Phase 1
Study Type
Interventional
Last Updated