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Assess the Anti-Tumor Activity and Safety of REGN1979 in Patients With Relapsed or Refractory Follicular Lymphoma

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ClinicalTrials.gov Identifier: NCT03888105
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The primary objective of this study is to assess the anti-tumor activity of single agent REGN1979, as measured by objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) by independent central review, in patients with follicular lymphoma (FL) that has relapsed or is refractory to at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.

The secondary objectives in this study are:

  • To assess the anti-tumor activity of single agent REGN1979 in patients with relapsed or refractory FL, as measured by:
  • ORR according to the Lugano Classification (Cheson, 2014) as assessed by local investigator evaluation
  • Complete response (CR) rate according to the Lugano Classification as assessed by independent central review and local investigator evaluation
  • Progression-free survival (PFS) according to Lugano Classification as assessed by independent central review and local investigator evaluation
  • Overall survival (OS)
  • Duration of response (DOR) according to the Lugano Classification as assessed by independent central review and local investigator evaluation
  • Disease control rate (DCR) according to the Lugano Classification as assessed by independent central review and local investigator evaluation
  • Duration of disease control (DDC) according to the Lugano Classification as assessed by independent central review and local investigator evaluation
  • To evaluate the safety and tolerability of REGN1979
  • To assess the pharmacokinetics (PK) of REGN1979
  • To assess the immunogenicity of REGN1979
  • To assess the effect of REGN1979 on quality of life as measured by the validated instruments European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L)

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Drug: REGN1979 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory Follicular Lymphoma
Actual Study Start Date : November 13, 2019
Estimated Primary Completion Date : July 11, 2024
Estimated Study Completion Date : July 11, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: REGN1979 Drug: REGN1979
Administered by intravenous (IV) infusion




Primary Outcome Measures :
  1. ORR [ Time Frame: From first dose until 194 weeks following the first dose ]
    As measured by the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and according to independent central review, in patients with FL that has relapsed or is refractory to at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.


Secondary Outcome Measures :
  1. ORR [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by local investigator evaluation

  2. CR rate [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by independent central review

  3. CR rate [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by local investigator evaluation

  4. PFS [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by independent central review

  5. PFS [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by local investigator evaluation

  6. OS [ Time Frame: From first dose until 194 weeks following the first dose ]
  7. DOR [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by independent central review

  8. DOR [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by local investigator evaluation

  9. DCR [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by independent central review

  10. DCR [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by local investigator evaluation

  11. DDC [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by independent central review

  12. DDC [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by local investigator evaluation

  13. Incidence and severity of treatment emergent adverse events (TEAEs) [ Time Frame: From first dose until 194 weeks following the first dose ]
  14. Changes in scores of patient-reported outcomes as measured by EORTC QLQ-C30 [ Time Frame: From first dose until 194 weeks following the first dose ]
    EORTC QLQ-C30 is a self-reported, 30-item generic questionnaire developed to assess 15 domains: global health status scale, five functional scales (physical, role, emotional, cognitive, and social functioning) and nine symptom scales (fatigue, nausea, vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties).

  15. Changes in scores of patient-reported outcomes as measured by EQ-5D-3L [ Time Frame: From first dose until 194 weeks following the first dose ]
    The EQ-5D-3L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.



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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:

  • Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017).
  • Disease must have relapsed or must be refractory to ≥2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent. Patients should in the opinion of the investigator require therapy for FL at the time of study enrollment.
  • Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI))
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate bone marrow, hepatic, and renal function as defined in the protocol

Key Exclusion Criteria:

  • Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI).
  • Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter.
  • History of allogeneic stem cell transplantation
  • Prior treatment with any chimeric antigen receptor T-cell (CAR-T) therapy
  • Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug
  • History of neurodegenerative condition or CNS movement disorder
  • History of uncontrolled seizure disorder, defined as any seizure within 12 months prior to study enrollment
  • Another malignancy except FL in the past 5 years, with the exception of non-melanoma skin cancer that has undergone potentially curative therapy or in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent.
  • Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or other uncontrolled infection as defined in the protocol
  • Known hypersensitivity to both allopurinol and rasburicase

Note: Other protocol defined 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): NCT03888105


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, Kentucky
Regeneron Study Site Recruiting
Louisville, Kentucky, United States, 40207
United States, Massachusetts
Regeneron Study Site Recruiting
Boston, Massachusetts, United States, 02215
United States, Minnesota
Regeneron Study Site Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Regeneron Study Site Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Regeneron Study Site Recruiting
Hackensack, New Jersey, United States, 07601
Canada, Alberta
Regeneron Study Site Recruiting
Edmonton, Alberta, Canada, T6G172
Italy
Regeneron Study Site Recruiting
Milano, Italy, 20122
Regeneron Study Site Recruiting
San Giovanni Rotondo, Italy, 71013
Korea, Republic of
Regeneron Study Site Recruiting
Busan, Korea, Republic of, 49201
Regeneron Study Site Recruiting
Daegu-si, Korea, Republic of, 41931
Regeneron Study Site Recruiting
Goyang-si, Korea, Republic of, 10408
Regeneron Study Site Recruiting
Seoul, Korea, Republic of, 02841
Regeneron Study Site Recruiting
Seoul, Korea, Republic of, 03080
Regeneron Study Site Recruiting
Seoul, Korea, Republic of, 03722
Regeneron Study Site Recruiting
Seoul, Korea, Republic of, 06351
Regeneron Study Site Recruiting
Seoul, Korea, Republic of, 06591
Regeneron Study Site Recruiting
Seoul, Korea, Republic of, 07985
Regeneron Study Site Recruiting
Ulsan, Korea, Republic of, 44033
Poland
Regeneron Study Site Recruiting
Gdańsk, Poland, 80-214
Regeneron Study Site Recruiting
Gdynia, Poland, 81-519
Singapore
Regeneron Study Site Recruiting
Singapore, Singapore, 217562
Taiwan
Regeneron Study Site Recruiting
Taipei City, Taiwan, 114
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: NCT03888105     History of Changes
Other Study ID Numbers: R1979-ONC-1625
2017-002139-41 ( EudraCT Number )
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
URL: https://errs.regeneron.com/external

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Relapsed
Refractory
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin