A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma

NCT06091865 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: R1979-ONC-21052022-502785-25-00
• Study Type: interventional
• Target: 904
• Locations: 19 countries
• Sites: 149

Brief Summary

This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with Diffuse Large B-cell Lymphoma (DLBCL) that have not been treated before (called "previously untreated"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study. This study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study. The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including:

• What side effects may happen from taking the study drug when combined with chemotherapy
• How much study drug is in the blood at different times
• Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
• The impact from the study drug on quality of life and ability to complete routine daily activities

Conditions

Diffuse Large B-cell Lymphoma (DLBCL)

Keywords

Non-Hodgkin Lymphomas (NHL); B-cell Non-Hodgkin Lymphomas (B-NHL); Diffuse Large B-cell Lymphoma; Odronextamab; Anti-CD20 × anti-CD3 bispecific antibody

Outcome Measures

Primary Outcomes (4)

• Incidence of Dose Limiting Toxicities (DLTs)

  Part 1A

  Up to 35 days

• Incidence of Treatment Emergent Adverse Events (TEAEs)

  Part 1

  Up to 2 years

• Severity of TEAEs

  Part 1

  Up to 2 years

• Progression Free Survival (PFS), assessed by Independent Central Review (ICR)

  Part 2

  Up to 5 years

Secondary Outcomes (23)

• Event-Free Survival (EFS) assessed by ICR

  Up to 5 years

• Complete Response (CR) assessed by ICR

  Up to 22 weeks

• Overall Survival (OS)

  Up to 5 years

• Best Overall Response (BOR) as assessed by local investigators

  Up to 22 weeks

• CR as assessed by local investigators

  Up to 22 weeks

Study Arms (2)

Odronextamab + CHOP

EXPERIMENTAL

Part 1, includes dose escalation (Part 1A), and randomized exploration of 2 regimens of odronextamab -cyclophosphamide, doxorubicin, vincristine, prednisone (Odro-CHOP) dose optimization (Part 1B).

Drug: Odronextamab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone/Prednisolone

Rituximab + CHOP

ACTIVE COMPARATOR

Part 2 is the randomized controlled portion, participants will receive either Odro-CHOP or R-CHOP.

Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone/Prednisolone

Interventions

Odronextamab DRUG

Odronextamab will be administered by intravenous (IV) infusion

Also known as: REGN1979, Ordspono™

Odronextamab + CHOP

Rituximab DRUG

Rituximab will be administered IV, or subcutaneously (SC)

Also known as: RITUXAN®

Rituximab + CHOP

Vincristine DRUG

Vincristine will be administered IV as part of chemotherapy

Also known as: Oncovin®, Vincasar PFS®

Odronextamab + CHOP; Rituximab + CHOP

Prednisone/Prednisolone DRUG

Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy

Also known as: Deltasone®/OMNIPRED®

Odronextamab + CHOP; Rituximab + CHOP

Cyclophosphamide DRUG

Cyclophosphamide will be administered IV as part of chemotherapy

Also known as: Cytoxan®

Odronextamab + CHOP; Rituximab + CHOP

Doxorubicin DRUG

Doxorubicin will be administered IV as part of chemotherapy

Also known as: Adriamycin®

Odronextamab + CHOP; Rituximab + CHOP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated participants for lymphoma with documented Cluster of Differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL, for whom next available standard of care therapy is not available or deemed ineligible according to the investigator (Part 1A only)
• Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• Life expectancy ≥ 12 months
• International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only
• Adequate hematologic and organ function, as defined in the protocol.

You may not qualify if:

• Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology
• Another active malignancy, significant active disease or medical condition, as described in the protocol
• Peripheral neuropathy Grade ≥3
• Treatment with any systemic anti-lymphoma therapy, except for participants with Relapsed/Refractory (R/R) DLBCL and participants with DLBCL transformed from an indolent lymphoma after treatment with systemic anti-lymphoma therapy.
• Any other therapy or investigational treatment within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment
• Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol
• Allergy/hypersensitivity to study drugs, as described in the protocol
• Infections such as any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other), active Coronavirus Disease (COVID-19) infection, uncontrolled infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV), Cytomegalovirus (CMV) infection, as described in the protocol.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (155)

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

RECRUITING

University of California Irvine Medical Center

Orange, California, 92868, United States

RECRUITING

University of California (UC) Davis

Sacramento, California, 95817, United States

RECRUITING

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

St Vincent Ascension at Peyton Manning Childrens Hospital

Indianapolis, Indiana, 46260, United States

RECRUITING

Investigative Clinical Research of Indiana

Noblesville, Indiana, 46062, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, 49503, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

Clinical Research Alliance Inc

Westbury, New York, 11590, United States

WITHDRAWN

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

East Carolina University

Greenville, North Carolina, 27834, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Center for Oncology and Blood Disorders

Houston, Texas, 77030, United States

WITHDRAWN

Community Cancer Trials of Utah

Ogden, Utah, 84405, United States

RECRUITING

Prohealth Care Inc

Waukesha, Wisconsin, 53188, United States

WITHDRAWN

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

RECRUITING

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

RECRUITING

Icon Cancer Centre - Wesley

Auchenflower, Queensland, 4066, Australia

RECRUITING

Pindara Private Hospital

Benowa, Queensland, 4217, Australia

RECRUITING

Epworth Freemasons

East Melbourne, Victoria, 3121, Australia

RECRUITING

Landeskrankenhaus Hochsteiermark

Leoben, Styria, 8700, Austria

RECRUITING

Kepler University Hospital

Linz, Upper Austria, 4020, Austria

RECRUITING

Medical University Graz

Graz, 8036, Austria

RECRUITING

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Hanusch Krankenhaus

Vienna, 1140, Austria

RECRUITING

Klinikum Wels-Grieskirchen

Wels, 4600, Austria

RECRUITING

AZ St.-Elisabeth Herentals vzw

Herentals, Antwerp, 2200, Belgium

RECRUITING

Centre Hospitalier Regional de Verviers

Verviers, Liege, 4800, Belgium

RECRUITING

Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Az Delta

Roeselare, West-Vlaanderen, 8800, Belgium

RECRUITING

Institut Jules Bordet

Brussels, 1000, Belgium

RECRUITING

Hospital Clinico Universidad de Los Andes

Santiago, Las Condes, 7620157, Chile

RECRUITING

Centro Oncologia de Precision Universidad Mayor

Santiago, Santiago Metropolitan, 7560907, Chile

RECRUITING

Inmunocel

Santiago, Santiago Metropolitan, 7580206, Chile

RECRUITING

Clinica Alemana de Santiago

Santiago, 7650568, Chile

RECRUITING

University Hospital Hradec Kralove

Hradec Králové, East Bohemia, 50005, Czechia

RECRUITING

University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

RECRUITING

Vseobecna Fakultni Nemocnice V Praze

Prague, 12808, Czechia

RECRUITING

Centre Hospitalier Universitaire (CHU) Rennes

Rennes, Brittany Region, 35033, France

RECRUITING

CHRU de Tours

Tours, Centre-Val de Loire, 37044, France

RECRUITING

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, Gironde, 33077, France

RECRUITING

Centre Hospitalier Universitaire (CHU) de Bordeaux

Pessac, New Aquitaine, 33600, France

RECRUITING

Centre Hospitalier Universitaire De Poitiers

Poitiers, New Aquitaine, 86000, France

RECRUITING

Hopital Saint Vincent-de-Paul

Lille, Nord, 5900, France

RECRUITING

Nantes University Hospital

Nantes, Pays de la Loire Region, 44093, France

RECRUITING

Centre Hospitalier Metropole Savoie

Chambéry, Savoie, 73000, France

RECRUITING

Centre Hospitalier Universitaire Angers

Angers, 49000, France

RECRUITING

Change Annecy

Metz-Tessy, 74374, France

RECRUITING

CHU Nimes Institut de Cancerologie

Nîmes, 30029, France

RECRUITING

Assistance Publique-Hopitaux de Paris (AP-HP)

Paris, 75571, France

RECRUITING

CHU de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

Hopital Victor Dupouy Argenteuil

Argenteuil, Île-de-France Region, 95100, France

RECRUITING

Avicenne Hospital

Bobigny, Île-de-France Region, 93000, France

RECRUITING

Gustave Roussy

Villejuif, Île-de-France Region, 94800, France

RECRUITING

Robert-Bosch-Krankenhaus

Stuttgart, Baden-Wurttemberg, 70376, Germany

RECRUITING

Kliniken Ostalb Stauferklinikum Schwab Gmund

Mutlangen, Gmund, D-73557, Germany

RECRUITING

Clinic Frankfurt (Oder)

Frankfurt am Main, Hesse, 15236, Germany

RECRUITING

University Hospital Essen

Essen, North Rhine-Westphalia, 45122, Germany

RECRUITING

Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

Hematological Praxis Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

University Hospital Carl Gustav Carus

Dresden, 01307, Germany

RECRUITING

Stadtisches Krankenhaus Kiel

Kiel, 24116, Germany

RECRUITING

Beaumont Hospital

Dublin, Leinster, D09V2N0, Ireland

WITHDRAWN

St James Hospital and Trinity College Dublin

Dublin, D08, Ireland

RECRUITING

The Chaim Sheba Medical Center

Tel Litwinsky, Tel Aviv, 5265601, Israel

RECRUITING

Samson Assuta Ashdod University Hospital

Ashdod, 7747629, Israel

RECRUITING

Bnai Zion Medical Center

Haifa, 31048, Israel

RECRUITING

Hadassah Medical Center

Jerusalem, 91200, Israel

RECRUITING

Galilee Medical Center

Nahariya, 2210001, Israel

RECRUITING

The Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Forli-Cesena, 47014, Italy

RECRUITING

ASST Monza Ospedale San Gerardo

Monza, Monza E Brianza, 20900, Italy

RECRUITING

Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

A.O.U. di Modena

Modena, 41124, Italy

RECRUITING

Federico II University

Naples, 80131, Italy

RECRUITING

AOU Maggiore della Carita

Novara, 28100, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

Azienda Ospedaliera di Perugia

Perugia, 06132, Italy

RECRUITING

Ospedale Santa Maria delle Croci

Ravenna, 48121, Italy

RECRUITING

Hematology - Città della Salute e della Scienza di Torino

Turin, 10126, Italy

RECRUITING

Santa Maria della Misericordia

Udine, 33100, Italy

RECRUITING

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

RECRUITING

Hospital Tg Ampuan Afzan

Kuantan, Pahang, 25200, Malaysia

RECRUITING

Hospital Queen Elizabeth

Kota Kinabalu, Sabah, 88200, Malaysia

RECRUITING

Hospital Ampang

Ampang, Selangor, 68000, Malaysia

RECRUITING

Subang Jaya Medical Center

Subang Jaya, Selangor, 47500, Malaysia

RECRUITING

Matopolskie Centrum Medyczne S.C.

Krakow, Lesser Poland Voivodeship, 30-510, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny

Wroclaw, Lower Silesian Voivodeship, 50-367, Poland

RECRUITING

Pratia Poznan Medical Center

Poznan, Wielkopolska, 60185, Poland

WITHDRAWN

Aidport

Skorzewo, Wielkopolska, 60185, Poland

RECRUITING

Szpital Uniwersytecki Nr2 Bydgoszcz

Bydgoszcz, 85-168, Poland

WITHDRAWN

Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center

Gdansk, 80-952, Poland

RECRUITING

Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Lublin, 20-954, Poland

RECRUITING

Szpital Szpecjalistyczny w Walbrzychu

Wałbrzych, 58-300, Poland

RECRUITING

Wielospecjalistyczne Centrum Onkologii i Traumatologii

Lodz, Łódź Voivodeship, 93-510, Poland

RECRUITING

National University Hospital Singapore

Singapore, 119074, Singapore

RECRUITING

National Cancer Centre of Singapore

Singapore, 168583, Singapore

RECRUITING

Tan Tock Seng Hospital

Singapore, 308433, Singapore

RECRUITING

St. Vincent Hospital - The Catholic University of Korea

Suwon, Gyeonggi-do, 16247, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, Namdong-Gu, 21565, South Korea

RECRUITING

Inje University Busan Paik Hospital

Busan, 47392, South Korea

RECRUITING

Dong-A University Hospital

Busan, 49201, South Korea

RECRUITING

Pusan National University Hospital

Busan, 49241, South Korea

RECRUITING

Yeyungnam University Medical Center

Daegu, 42415, South Korea

RECRUITING

Keimyung University Dongsan Hospital

Daegu, 42601, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Yeouido St. Marys Hospital

Seoul, 07345, South Korea

RECRUITING

Seoul St Marys Hospital

Seoul, 137-701, South Korea

RECRUITING

Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, A Coruna, 15706, Spain

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, Andalusia, 41013, Spain

RECRUITING

Son Espases University Hospital

Palma, Balearic Islands, 07120, Spain

RECRUITING

Hospital Universitari Parc Tauli

Sabadell, Barcelona, 08208, Spain

RECRUITING

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, 08221, Spain

RECRUITING

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Hospital Sant Pau

Barcelona, 08041, Spain

RECRUITING

Hospital Virgen De Las Nieves De Granada

Granada, 18014, Spain

RECRUITING

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Fundacion Jimenez Diaz University Hospital

Madrid, 28040, Spain

RECRUITING

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Hospital General Universitario de Toledo

Toledo, 45007, Spain

WITHDRAWN

Instituto Valenciano de Oncologia

Valencia, 46009, Spain

RECRUITING

University Hospital Doctor Peset

Valencia, 46017, Spain

RECRUITING

Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

Valencia, 46026, Spain

RECRUITING

Chang Gung Medical Foundation Chia Yi Branch

Buzi, Chiayi County, 613, Taiwan

RECRUITING

Chang Gung Memorial Hospital - Linkou Branch

Taoyuan, Hunan Province, 33305, Taiwan

RECRUITING

Changhua Christian Hospital

Changhua, 50006, Taiwan

RECRUITING

Taipei Medical University - Shuang Ho Hospital

New Taipei City, 23561, Taiwan

RECRUITING

Wanfang Hospital

Taipei, 00116, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Chulalongkorn University

Bangkok, Krung Thep Maha Nakhon [Bangko], 10330, Thailand

RECRUITING

Sriraj Hospital

Bangkok, 10700, Thailand

RECRUITING

Chaing Mai University

Chiang Mai, 50200, Thailand

RECRUITING

Faculty of Medicine

Khon Kaen, 40002, Thailand

RECRUITING

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Yenimahalle, Ankara, 06200, Turkey (Türkiye)

RECRUITING

VM Medical Park Mersin Hospital

Mezitli, Mersin, 33200, Turkey (Türkiye)

RECRUITING

Tekirdag Namik Kemal University Hospital

Tekirdağ, Suleymanpasa, 59100, Turkey (Türkiye)

RECRUITING

Gazi Universitesi

Beşevler, 6500, Turkey (Türkiye)

RECRUITING

Istanbul University Istanbul Faculty of Medicine

Istanbul, 34418, Turkey (Türkiye)

RECRUITING

Ege University

Izmir, 35100, Turkey (Türkiye)

RECRUITING

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

RECRUITING

Sakarya University Medical Faculty

Sakarya, 54290, Turkey (Türkiye)

RECRUITING

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

Samsun, 55239, Turkey (Türkiye)

RECRUITING

NHS Grampian: Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

RECRUITING

The Hillingdon Hospitals NHS Foundation Trust

Uxbridge, UB8 3NN, United Kingdom

RECRUITING

Related Links

• OLYMPIA

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Prednisolone

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: December 13, 2023
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): September 12, 2029
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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 or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

PL (9); IE (2); KR (11); IL (6); TW (6); TH (4); US (20); IT (11); CZ (3); CL (4); FR (16); GB (2); BE (5); DE (8); ES (20); SG (3); AU (5); TU (9); MY (5)