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Study of Cemiplimab and REGN1979 in Patients With Lymphoma

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ClinicalTrials.gov Identifier: NCT02651662
Recruitment Status : Recruiting
First Posted : January 11, 2016
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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
Lymphoma Drug: cemiplimab Drug: REGN1979 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 11, 2016
Estimated Primary Completion Date : October 11, 2021
Estimated Study Completion Date : October 11, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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




Primary Outcome Measures :
  1. Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Up to 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651662


Contacts
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Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
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United States, California
Regeneron Research Facility Recruiting
Santa Monica, California, United States, 90404
United States, Maryland
Regeneron Research Facility Recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Regeneron Research Facility Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Regeneron Research Facility Completed
Grand Rapids, Michigan, United States, 49503
United States, New Hampshire
Regeneron Research Facility Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New York
Regeneron Research Facility Recruiting
New York, New York, United States, 10065
United States, Ohio
Regeneron Research Facility Recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Regeneron Research Facility Completed
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Regeneron Research Facility Recruiting
San Antonio, Texas, United States, 78229
Germany
Regeneron Research Facility Recruiting
Cologne, Germany, 50937
Regeneron Research Facility Recruiting
Frankfurt, Germany, 60590
Regeneron Research Facility Completed
Jena, Germany, 07747
Regeneron Research Facility Recruiting
Kiel, Germany, 24105
Regeneron Research Facility Recruiting
Würzburg, Germany, 97080
Spain
Regeneron Research Facility Recruiting
Barcelona, Spain, 08035
Regeneron Research Facility Recruiting
Madrid, Spain, 28040
Regeneron Research Facility Recruiting
Majadahonda, Spain, 28222
Regeneron Research Facility Recruiting
Salamanca, Spain, 37007
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02651662     History of Changes
Other Study ID Numbers: R1979-ONC-1504
2015-001697-17 ( EudraCT Number )
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents