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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 : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 14, 2019
First Posted Date  ICMJE March 25, 2019
Last Update Posted Date November 26, 2019
Actual Study Start Date  ICMJE November 13, 2019
Estimated Primary Completion Date July 11, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03888105 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • ORR [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by local investigator evaluation
  • 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
  • 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
  • PFS [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by independent central review
  • PFS [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by local investigator evaluation
  • OS [ Time Frame: From first dose until 194 weeks following the first dose ]
  • DOR [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by independent central review
  • DOR [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by local investigator evaluation
  • DCR [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by independent central review
  • DCR [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by local investigator evaluation
  • DDC [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by independent central review
  • DDC [ Time Frame: From first dose until 194 weeks following the first dose ]
    According to the Lugano Classification, as assessed by local investigator evaluation
  • Incidence and severity of treatment emergent adverse events (TEAEs) [ Time Frame: From first dose until 194 weeks following the first dose ]
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assess the Anti-Tumor Activity and Safety of REGN1979 in Patients With Relapsed or Refractory Follicular Lymphoma
Official Title  ICMJE 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
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Follicular Lymphoma
Intervention  ICMJE Drug: REGN1979
Administered by intravenous (IV) infusion
Study Arms  ICMJE Experimental: REGN1979
Intervention: Drug: REGN1979
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2019)
112
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 11, 2024
Estimated Primary Completion Date July 11, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com
Listed Location Countries  ICMJE Canada,   Italy,   Korea, Republic of,   Poland,   Singapore,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03888105
Other Study ID Numbers  ICMJE R1979-ONC-1625
2017-002139-41 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP