Study of Cemiplimab and REGN1979 in Patients With Lymphoma

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02651662
Collaborator
(none)
172
22
2
127.2
7.8
0.1

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
172 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 11, 2016
Anticipated Primary Completion Date :
Aug 19, 2026
Anticipated Study Completion Date :
Aug 19, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Open label (cemiplimab)

Experimental cohorts will consist of multiple dose levels of cemiplimab administered intravenously (IV) every 2 weeks (Q2W)

Drug: cemiplimab
Multiple dose levels administered IV Q2W
Other Names:
  • REGN2810
  • Libtayo
  • Experimental: Open label (cemiplimab and REGN1979)

    Experimental cohorts will consist of a single dose level of cemiplimab administered intravenously (IV) and multiple dose levels of REGN1979 administered intravenously (IV)

    Drug: cemiplimab
    Multiple dose levels administered IV Q2W
    Other Names:
  • REGN2810
  • Libtayo
  • Drug: REGN1979
    Single dose level of cemiplimab and multiple dose levels of REGN1979 administered IV

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of treatment emergent adverse events (TEAEs) [Up to 18 months]

      TEAEs include abnormal laboratory findings and dose limiting toxicities (DLTs)

    Secondary Outcome Measures

    1. Pharmacokinetics (PK) of cemiplimab when given alone, and of cemiplimab and REGN1979 when given in combination [Up to 18 months]

      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

    2. Antitumor activity (includes response evaluation per Cheson and Lugano criteria) [Up to 18 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Regeneron Research Facility Santa Monica California United States 90404
    2 Regeneron Research Facility Baltimore Maryland United States 21287
    3 Regeneron Research Facility Boston Massachusetts United States 02215
    4 Regeneron Research Facility Grand Rapids Michigan United States 49503
    5 Regeneron Research Facility Lebanon New Hampshire United States 03756
    6 Regeneron Research Facility New York New York United States 10065
    7 Regeneron Research Facility Cleveland Ohio United States 44106
    8 Regeneron Research Facility Cleveland Ohio United States 44195
    9 Regeneron Research Facility Philadelphia Pennsylvania United States 19104
    10 Regeneron Research Facility San Antonio Texas United States 78229
    11 Regeneron Research Facility Heidelberg Baden-Wurttemberg Germany 69120
    12 Regeneron Research Facility Cologne Germany 50937
    13 Regeneron Research Facility Frankfurt Germany 60590
    14 Regeneron Research Facility Jena Germany 07747
    15 Regeneron Research Facility Kiel Germany 24105
    16 Regeneron Research Facility Würzburg Germany 97080
    17 Regeneron Research Facility Barcelona Spain 08035
    18 Regeneron Research Facility Madrid Spain 28033
    19 Regeneron Research Facility Madrid Spain 28040
    20 Regeneron Research Facility Madrid Spain 28041
    21 Regeneron Research Facility Majadahonda Spain 28222
    22 Regeneron Research Facility Salamanca Spain 37007

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02651662
    Other Study ID Numbers:
    • R1979-ONC-1504
    • 2015-001697-17
    First Posted:
    Jan 11, 2016
    Last Update Posted:
    Sep 22, 2021
    Last Verified:
    Sep 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 22, 2021