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Study of REGN2810 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 : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
This is an open-label, multicenter, dose escalation study of REGN2810 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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: REGN2810 Drug: REGN1979 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Open label (REGN2810)
Experimental cohorts will consist of multiple dose levels of REGN2810 administered intravenously (IV) every 2 weeks (Q2W)
Drug: REGN2810
Experimental: Open label (REGN2810 and REGN1979)
Experimental cohorts will consist of a single dose level of REGN2810 administered intravenously (IV) and multiple dose levels of REGN1979 administered intravenously (IV)
Drug: REGN2810 Drug: REGN1979



Primary Outcome Measures :
  1. Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: Baseline to Week 72 (End of study) ]
    TEAEs include abnormal laboratory findings and dose limiting toxicities (DLTs)


Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of REGN2810 or REGN1979 [ Time Frame: Baseline to Week 72 (End of study) ]

    PK variables of REGN2810 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. Immunogenicity (anti-REGN2810 or anti REGN1979 antibodies) [ Time Frame: Baseline to Week 72 ]
  3. Antitumor activity [includes response evaluation per Cheson criteria) [ Time Frame: Baseline to Week 72 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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. Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with hepatitis B virus or hepatitis C virus
  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

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
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
United States, California
Recruiting
Santa Monica, California, United States
United States, Maryland
Recruiting
Baltimore, Maryland, United States
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States
United States, Michigan
Recruiting
Grand Rapids, Michigan, United States
United States, New Hampshire
Recruiting
Lebanon, New Hampshire, United States
United States, New York
Recruiting
New York, New York, United States
United States, Ohio
Recruiting
Cleveland, Ohio, United States
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States
United States, Texas
Recruiting
San Antonio, Texas, United States
Germany
Recruiting
Cologne, Germany
Recruiting
Frankfurt, Germany
Recruiting
Jena, Germany
Recruiting
Kiel, Germany
Recruiting
Würzburg, Germany
Spain
Recruiting
Barcelona, Spain
Recruiting
Madrid, Spain
Recruiting
Majadahonda, Spain
Recruiting
Salamanca, Spain
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02651662     History of Changes
Other Study ID Numbers: R1979-ONC-1504
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases