Clinical Trials /

Study of Cemiplimab and REGN1979 in Patients With Lymphoma

NCT02651662

Description:

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

Related Conditions:
  • Classical Hodgkin Lymphoma
  • Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of Cemiplimab and REGN1979 in Patients With Lymphoma
  • 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

Clinical Trial IDs

  • ORG STUDY ID: R1979-ONC-1504
  • SECONDARY ID: 2015-001697-17
  • NCT ID: NCT02651662

Conditions

  • Lymphoma

Interventions

DrugSynonymsArms
cemiplimabREGN2810, LibtayoOpen label (cemiplimab and REGN1979)
REGN1979Open label (cemiplimab and REGN1979)

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Open label (cemiplimab)ExperimentalExperimental cohorts will consist of multiple dose levels of cemiplimab administered intravenously (IV) every 2 weeks (Q2W)
  • cemiplimab
Open label (cemiplimab and REGN1979)ExperimentalExperimental cohorts will consist of a single dose level of cemiplimab administered intravenously (IV) and multiple dose levels of REGN1979 administered intravenously (IV)
  • cemiplimab
  • REGN1979

Eligibility Criteria

        Key Inclusion Criteria [(Non-Hodgkin Lymphoma (NHL) and Hodgkin Lymphoma (HL)]:

          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

        Key Exclusion Criteria (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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of treatment emergent adverse events (TEAEs)
Time Frame:Up to 18 months
Safety Issue:
Description:TEAEs include abnormal laboratory findings and dose limiting toxicities (DLTs)

Secondary Outcome Measures

Measure:Pharmacokinetics (PK) of cemiplimab when given alone, and of cemiplimab and REGN1979 when given in combination
Time Frame:Up to 18 months
Safety Issue:
Description:PK variables of cemiplimab may include, but are not limited to, the following: Area under the concentration-time curve (AUC) over a dosing interval, the peak concentration and last positive (quantifiable) concentration
Measure:Antitumor activity (includes response evaluation per Cheson and Lugano criteria)
Time Frame:Up to 18 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Regeneron Pharmaceuticals

Last Updated

November 11, 2019