A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With B-cell Non-Hodgkin Lymphoma That Have Been Previously Treated (ELM-2)

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 B-cell Non-Hodgkin Lymphoma

Primary objective is to assess the anti-tumor activity of single agent odronextamab as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review in each of the following B-cell non-Hodgkin lymphoma (B-NHL) subgroups:

• In patients with follicular lymphoma (FL) grade 1-3a *1,2
• In patients with diffuse large B-cell lymphoma (DLBCL) *1,2
• In patients with mantle cell lymphoma (MCL) that has relapsed after or is refractory to a BTK inhibitor. This cohort will also include patients who have relapsed or have disease refractory to prior systemic therapy, or patients who have demonstrated intolerance to BTK inhibitor therapy, and who have progressed after other systemic therapy.
• In patients with marginal zone lymphoma (MZL) *1
• In patients with other B-NHL subtypes *1

Secondary objectives are:

• To assess the anti-tumor activity of single agent odronextamab in each of 5 disease-specific cohorts, as measured by:
• ORR according to the Lugano Classification and as assessed by local investigator evaluation
• Complete response (CR) rate according to the Lugano Classification and as assessed local by local investigator evaluation and independent central review
• Progression-free survival (PFS)*3
• Overall survival (OS)
• Duration of response (DOR)*3
• Disease control rate (DCR)*3
• To evaluate the safety and tolerability of odronextamab
• To assess the pharmacokinetics (PK) of odronextamab
• To assess the immunogenicity of odronextamab

• To assess the effect of odronextamab on patient reported outcomes, including health-related quality of life (HRQL), as measured by the validated instruments European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym), and EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L)

  • 1 that has relapsed after or is refractory to at least 2 prior lines of systemic therapy
  • 2 including an anti-CD20 antibody and an alkylating agent
  • 3 according to Lugano Classification and as assessed by independent central review and local investigator evaluation

Study Overview

• Status: Recruiting
• Conditions: B-cell Non-Hodgkin Lymphoma (NHL)
• Intervention / Treatment: Drug: Odronextamab

• Study Type: Interventional
• Enrollment (Estimated): 512
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clinical Trials Administrator; Phone Number: 844-734-6643; Email: clinicaltrials@regeneron.com

Study Locations

• Australia
  • East Albury, Australia, NSW 2640
    • Recruiting
    • Border Medical Oncology, Albury Wodonga Regional Cancer Centre
  • East Melbourne, Australia, VIC 3002
    • Recruiting
    • Epworth Hospital
  • Frankston, Australia, VIC 3199
    • Recruiting
    • Penninsula & South Eastern Haemotology and Oncology Group
  • Geelong, Australia, VIC 3220
    • Recruiting
    • Andrew Love Cancer Center
  • Heidelberg, Australia, VIC 3084
    • Recruiting
    • Olivia Newton John Cancer Centre
  • Murdoch, Australia, NSW 2485
    • Completed
    • The Tweed Hospital
  • Perth, Australia, 6000
    • Completed
    • Royal Perth Hospital
  • Tweed Heads, Australia, VIC3220
    • Recruiting
    • Andrew Love Cancer Center
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G172
      • Recruiting
      • Cross Cancer Center
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Recruiting
      • QEII Health Science Center
• China
  • Beijing, China, 100191
    • Recruiting
    • Peking University Third Hospital
  • Beijing, China, 100730
    • Recruiting
    • Peking Union Medical College Hospital
  • Canton, China, 150060
    • Recruiting
    • Sun Yat-Sen University Cancer Center (Cancer Prevention and Treatment Center, Sun Yat-sen University)
  • Chongqing, China, 400000
    • Recruiting
    • Second Affiliated Hospital of Army Medical University, PLA
  • Heilongjiang, China, 150000
    • Recruiting
    • Harbin Medical University Cancer Hospital
  • Shanghai, China, 200032
    • Recruiting
    • Fudan University Cancer Hospital
  • Tianjin, China, 300060
    • Recruiting
    • Tianjin Medical University Cancer Institute & Hospital
  • Tianjin, China, 300020
    • Recruiting
    • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
  • Wuhan, China, 430060
    • Recruiting
    • Renmin Hospital of Wuhan University
  • Xi'an, China, 710000
    • Recruiting
    • The First Affiliated Hospital of Xi 'an Jiaotong University
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Peking University Cancer Hospital (Beijing Cancer Hospital) (Beijing Institute for Cancer Research)
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
  • Jiangsu
    • Suzhou, Jiangsu, China, 215031
      • Recruiting
      • The First Affiliated Hospital of Soochow University
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Bethune Hospital of Jilin University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital of Sichuan University
  • Wuhan Hubei Province
    • Wuhan, Wuhan Hubei Province, China, 430030
      • Recruiting
      • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310052
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
• France
  • Caen, France, 14 000
    • Recruiting
    • CHU de Caen
  • Créteil, France, 94010
    • Recruiting
    • Hospital Henri Mondor
  • Lille, France, 59037
    • Recruiting
    • Hopital Huriez-CHRU Lille
  • Nantes, France, 44093
    • Recruiting
    • CHU de Nantes
  • Paris, France, 75013
    • Recruiting
    • Hopital de la Pitie Salpetriere
  • Paris, France, 75010
    • Recruiting
    • Hôspital Saint-Louis
  • Pessac, France, 33604
    • Recruiting
    • CHU Haut Leveque
  • Pierre Bénite, France, 69310
    • Recruiting
    • Centre Hospitalier Lyon Sud
  • Poitiers, France, 86021
    • Recruiting
    • Centre Hospitalier Universitaire (CHU) de Poitiers
• Germany
  • Chemnitz, Germany, 09116
    • Recruiting
    • Klinikum Chemnitz gGmbH Klinik fuer Innere Medizin III
  • Halle, Germany, 06120
    • Recruiting
    • University Hospital Halle Saale
  • Mutlangen, Germany, 73557
    • Recruiting
    • Kliniken Ostalb, Stauferklinikum
  • Villingen-Schwenningen, Germany, 78052
    • Recruiting
    • Klinik fur Innere Medizin II Schwarzwald Baar Klinikum
  • Wurzburg, Germany, 97080
    • Recruiting
    • Universitätsklinikum Würzburg
• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Policlinico Sant'Orsola Malpipghi
  • Firenze, Italy, 50139
    • Recruiting
    • Azienda Ospedaliera Careggi
  • Livorno, Italy, 57124
    • Recruiting
    • Ospedale Di Livorno Usl6
  • Milano, Italy, 20162
    • Recruiting
    • ASST Grande Ospedale Metropolitano Niguarda
  • Milano, Italy, 20122
    • Recruiting
    • Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico
  • Novara, Italy, 28100
    • Recruiting
    • AOU Maggiore della Carità
  • Perugia, Italy, 06129
    • Recruiting
    • Santa Maria della Misericordia Hospital
  • Ravenna, Italy, 48121
    • Recruiting
    • Ospedale Santa Maria delle Croci
  • Reggio Emilia, Italy, 42123
    • Recruiting
    • SC Ematologia Dip to Oncologico e Tecnologie Avanzate_ IRCCS - Arcispedale Santa Maria Nuova
  • San Giovanni Rotondo, Italy, 71013
    • Recruiting
    • Struttura Complessa di Ematologia e Trapianto di cellule staminali emopoietiche _ IRCCS Casa Sollievo della Sofferenza
  • Terni, Italy, 05100
    • Completed
    • A.O. Santa Maria
  • Varese, Italy, 21100
    • Recruiting
    • Ospedale dell'Angelo
  • Venice, Italy, 30174
    • Recruiting
    • Ospedale DellAngelo Di Mestre Umberto I
• Japan
  • Chiba, Japan, 260-8717
    • Recruiting
    • Chiba Cancer Center
  • Chuo ku, Japan, 104-0045
    • Recruiting
    • National Cancer Center Hospital
  • Isehara-Shi, Japan, 259-1193
    • Recruiting
    • Tokai University Hospital
  • Nagasaki, Japan, 852-8511
    • Recruiting
    • Japanese Red Cross Nagasaki Genbaku Hospital
  • Osaka City, Japan, 545-8586
    • Recruiting
    • Osaka Metropolitan University Hospital
  • Saitama, Japan, 350-1298
    • Recruiting
    • Saitama Medical University International Medical Center
  • Yamagata City, Japan, 990-9585
    • Recruiting
    • Yamagata University Hospital
  • Aiti
    • Nagoya, Aiti, Japan, 460-0001
      • Recruiting
      • National Hospital Organization Nagoya Medical Center
    • Nagoya, Aiti, Japan, 466-8650
      • Recruiting
      • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
  • Chiba-ken
    • Kashiwa-shi, Chiba-ken, Japan, 277-8577
      • Recruiting
      • National Cancer Center Hospital East
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • Recruiting
      • National Hospital Organization Shikoku Cancer Center
  • Hukuoka
    • Fukuoka-shi, Hukuoka, Japan, 811-1395
      • Recruiting
      • National Hospital Organization National Kyushu Cancer Center
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0047
      • Recruiting
      • Kobe City Medical Center General Hospital
  • Kyoto
    • Kyoto City, Kyoto, Japan, 602-8566
      • Recruiting
      • " University Hospital Kyoto Prefectural University of Medicine"
• Korea, Republic of
  • Busan, Korea, Republic of, 49201
    • Recruiting
    • Dong-A University Hospital
  • Daegu-si, Korea, Republic of, 41931
    • Recruiting
    • Keimyung University Dongsan Medical Center
  • Goyang-si, Korea, Republic of, 10408
    • Recruiting
    • National Cancer Center
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06591
    • Recruiting
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Severance Hospital
  • Seoul, Korea, Republic of, 02841
    • Recruiting
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 07985
    • Recruiting
    • Ewha Womans University Mokdong Hospital
  • Ulsan, Korea, Republic of, 44033
    • Recruiting
    • Ulsan University Hospital
• Poland
  • Gdańsk, Poland, 80-214
    • Recruiting
    • Uniwersyteckie Centrum Kliniczne
  • Gdynia, Poland, 81-519
    • Recruiting
    • Szpitale Pomorskie spSp. Z.o.o.
  • Krakow, Poland, 30-510
    • Recruiting
    • Małopolskie Centrum Medyczne S.C
  • Lodz, Poland, 93-513
    • Recruiting
    • Regeneron Study Site
  • Warszawa, Poland, 00-791
    • Recruiting
    • Apteka IHiT (Instytut Hematologii I Transfuzjologii
  • Warszawa, Poland, 02-781
    • Recruiting
    • Instytut im. M. Sklodowskiej-Curie
  • Wrocław, Poland, 50-367
    • Recruiting
    • Uniwersytecki Szpital Kliniczny
• Singapore
  • Singapore, Singapore, 169608
    • Recruiting
    • Singapore General Hospital
  • Singapore, Singapore, 119074
    • Recruiting
    • National University Hospital
  • Singapore, Singapore, 217562
    • Recruiting
    • ICON-SOC Farrer Park Hospital
  • Singapore, Singapore, 188770
    • Completed
    • Raffles Cancer Center
• Spain
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clínic i Provincial de Barcelona
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitario Vall De'Hebron
  • Donostia, Spain, 20014
    • Terminated
    • Hospital Universitario Donostia
  • L'Hospitalet de llobregat, Spain, 08908
    • Recruiting
    • Institut Catala d'Oncologia
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 De Octubre
  • Madrid, Spain, 28050
    • Recruiting
    • Hospital Universitario HM Sanchinarro
  • Madrid, Spain, 28040
    • Recruiting
    • Fundacion Jimenez Diaz University Hospital
  • Madrid, Spain, 28223
    • Recruiting
    • Hospital Universitario Quiron Salud Madrid
  • Madrid, Spain, 28033
    • Completed
    • MD Anderson Cancer Center
  • Marbella, Spain, 29603
    • Completed
    • Hospital Costa del Sol
  • Palma, Spain, 07120
    • Recruiting
    • Hospital Son Espases
  • Palma de Mallorca, Spain, 07198
    • Completed
    • Hospital Son Llatzer
  • Salamanca, Spain, 37007
    • Recruiting
    • Hospital Universitario de Salamanca
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitari i Politècnic La Fe
• Taiwan
  • Kaohsiung, Taiwan, 833
    • Recruiting
    • Kaosiung Chang Gung Memorial Hospital
  • New Taipei City, Taiwan, 23561
    • Recruiting
    • Taipei Medical University - Shuang-Ho Hospital
  • Taichung City, Taiwan, 40447
    • Recruiting
    • China Medical University Hospital
  • Tainan, Taiwan, 736
    • Recruiting
    • Chi-Mei Medical Center-Liuying
  • Tainan City, Taiwan, 702
    • Recruiting
    • National Cheng Kung University Hospital
  • Taipei City, Taiwan, 10002
    • Recruiting
    • National Taiwan University Hospital
  • Taipei City, Taiwan, 11251
    • Recruiting
    • Koo Foundation Sun Yat Sen Cancer Center
  • Taipei City, Taiwan, 114
    • Recruiting
    • Tri-Service General Hospital
  • Taipei City, Taiwan, 10449
    • Completed
    • Mackay Memorial Hospital
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung Memorial Hospital
• United Kingdom
  • Cardiff, United Kingdom, CF14 4XW
    • Recruiting
    • University Hospital of Wales
  • Edinburgh, United Kingdom, EH4 2XU
    • Completed
    • Western General Hospital
  • London, United Kingdom, SE5 9RS
    • Recruiting
    • Kings College Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • Recruiting
    • Derriford Hospital
  • Sutton, United Kingdom, SM2 5PT
    • Recruiting
    • The Royal Marsden Hospital
  • Truro, United Kingdom, TR1 3LJ
    • Recruiting
    • Royal Cornwall Hospital
• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa Hospital and Clinics
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Recruiting
      • Norton Cancer Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Active, not recruiting
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02332
      • Recruiting
      • Tufts Cancer Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Completed
      • University of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • University/Academic Hospital Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Completed
      • SSM Saint Louis University Hospital
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • John Theurer Cancer Center Hackensack University Medical Center
    • Morristown, New Jersey, United States, 07960
      • Completed
      • Morristown Medical Center
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medical College
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Baptist Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • Stephenson Cancer Center
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • Simmons Comprehensive Cancer Center
    • Fort Sam Houston, Texas, United States, 78234
      • Completed
      • Brook Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the "other B-NHL" cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017).
• Disease-specific cohorts that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
• DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
• MCL after BTK inhibitor therapy cohort: New enrollment is paused until further notice
• MZL cohort: Patients with MZL that have relapsed or is refractory to at least 2 prior lines of systemic therapy.
• Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol. New enrollment stopped for patients with Burkitt lymphoma and Burkitt-like lymphoma.
• Patients should in the judgment of the investigator require systemic therapy for lymphoma 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. Patients with a history of seizure within 12 months prior to study enrollment are excluded
• Another malignancy except B-NHL 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; cytomegalovirus (CMV) infection as noted by detectable levels on a blood polymerase chain reaction (PCR) assay as defined in the protocol or other uncontrolled infections
• Known hypersensitivity to both allopurinol and rasburicase
• Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FL; Follicular lymphoma grade 1-3a cohort	Drug: Odronextamab; Administered by intravenous (IV) infusion; Other Names: REGN1979
Experimental: DLBCL; Diffuse large B-cell lymphoma cohort	Drug: Odronextamab; Administered by intravenous (IV) infusion; Other Names: REGN1979
Experimental: MCL; Mantle Cell Lymphoma cohort	Drug: Odronextamab; Administered by intravenous (IV) infusion; Other Names: REGN1979
Experimental: MZL; Marginal Zone Lymphoma cohort	Drug: Odronextamab; Administered by intravenous (IV) infusion; Other Names: REGN1979
Experimental: Other B-NHL; Other B-cell non-Hodgkin lymphoma cohort (excluding FL Grade 1-3a, DLBCL, MCL, MZL, Waldenström macroglobulinemia [WM]); Patients with a current diagnosis of mixed histology of B-NHL with an aggressive component (such as concurrent FL and DLBCL) will be allowed	Drug: Odronextamab; Administered by intravenous (IV) infusion; Other Names: REGN1979

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR (FL grade 1-3a/MZL)	For each of the 5 disease-specific cohorts according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review.	From first patient first dose until all patients have completed 52 weeks of study treatment or have withdrawn from the study
ORR (DLBCL/MCL/Other B-NHL)	For each of the 5 disease-specific cohorts according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review.	From first patient first dose until all patients have completed 36 weeks of study treatment or have withdrawn from the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR (FL/MZL)	According to the Lugano Classification, as assessed by local investigator evaluation	First patient first dose until all patients have completed 52 weeks of study treatment or have withdrawn from the study.
ORR (DLBCL/MCL/Other B-NHL)	According to the Lugano Classification, as assessed by local investigator evaluation	First patient first dose until all patients have completed 36 weeks of study treatment or have withdrawn from the study.
CR rate (FL grade 1-3a/MZL)	According to the Lugano Classification and as assessed by local investigator evaluation and independent central review	First patient first dose until all patients have completed 52 weeks of study treatment or have withdrawn from the study.
CR rate (DLBCL/MCL/Other B-NHL)	According to the Lugano Classification and as assessed by local investigator evaluation and independent central review	First patient first dose until all patients have completed 36 weeks of study treatment or have withdrawn from the study.
PFS	According to the Lugano Classification and as assessed by independent central review and local investigator evaluation	First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
OS		First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
DOR	According to the Lugano Classification and as assessed by independent central review and local investigator evaluation	First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
DCR (FL grade 1-3a/MZL)	According to the Lugano Classification and as assessed by independent central review and local investigator evaluation	First patient first dose until all patients have completed 52 weeks of study treatment or have withdrawn from the study.
DCR (DLBCL/MCL/Other B-NHL)	According to the Lugano Classification and as assessed by independent central review and local investigator evaluation	First patient first dose until all patients have completed 36 weeks of study treatment or have withdrawn from the study.
Incidence and severity of treatment emergent adverse events (TEAEs)		First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
Pharmacokinetics: Concentration of odronextamab	End of infusion [EOI]; Concentration at a specified time t [Ct])	12 weeks following end of treatment
Incidence of anti-drug antibodies (ADA) to odronextamab over time		12 weeks following end of treatment
Titer of anti-drug antibodies to odronextamab over time		12 weeks following end of treatment
Incidence of neutralizing antibodies (Nab) to odronextamab over time		12 weeks following end of treatment
Changes in scores of patient-reported outcomes as measured by EORTC QLQ-C30	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).	First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
Changes in scores of patient-reported outcomes as measured by FACT-Lym	Composed of the FACT-G plus the 15-item Lymphoma Subscale (LymS).	First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
Changes in scores of patient-reported outcomes as measured by EQ-5D-3L	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.	First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Estimated): December 19, 2025
• Study Completion (Estimated): February 5, 2028

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: DLBCL; NHL; FL; MCL; MZL; CD20; bispecific antibody; Relapsed B-NHL; Refractory B-NHL
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: R1979-ONC-1625; 2017-002139-41 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
• IPD Sharing 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.
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No