A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma
OLYMPIA-2
A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20x Anti-CD3 Bispecific Antibody, Combined With Chemotherapy Versus Rituximab Combined With Chemotherapy in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-2)
2 other identifiers
interventional
733
16 countries
138
Brief Summary
This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Participants with follicular lymphoma that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory") are eligible to take part only in Part 1A of the study. This study is made up of 3 parts: Part 1A (non-randomized), Part 1B and Part 2 (randomized - controlled). 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 to be used in Part 2 of the study. The aim of Part 2 of the study is to assess how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab and chemotherapy (the current standard-of-care for NHL). 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
- 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2023
Longer than P75 for phase_3
138 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2023
CompletedFirst Posted
Study publicly available on registry
October 24, 2023
CompletedStudy Start
First participant enrolled
November 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 29, 2029
February 6, 2026
September 1, 2025
5.7 years
October 18, 2023
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Incidence of dose limiting toxicities (DLTs) for odronextamab in combination with chemotherapy
Part 1, DLT period
Up to 35 days
Incidence of treatment-emergent adverse events (TEAEs) of odronextamab in combination with chemotherapy
Part 1, Treatment period
Up to 2 years
Severity of TEAEs of odronextamab in combination with chemotherapy
Part 1, Treatment period
Up to 2 years
Complete Response rate at 30 months (CR30) assessed by independent central review (ICR)
Part 2
Up to 30 months
Secondary Outcomes (30)
Odronextamab concentrations in serum when administered with chemotherapy
Up to 30 months
Odronextamab concentrations in serum when administered as monotherapy
Up to 30 months
Incidence of anti-odronextamab antibodies (ADAs)
Up to 30 months
Titers of ADAs to odronextamab
Up to 30 months
Incidence of neutralizing antibodies (NAb) to odronextamab
Up to 30 months
- +25 more secondary outcomes
Study Arms (4)
Odronextamab + Chemotherapy
EXPERIMENTALPart 1 of the study includes ordonextamab dose escalation for participants with previously untreated FL and relapsed/refractory FL (Part 1A only) followed by a randomized exploration of 2 regimens of odronextamab (Odro) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) with the objective of dose optimization (Part 1B) in previously untreated patients with FL.
Rituximab + Chemotherapy
ACTIVE COMPARATORIn Part 2 only, participants will be randomized 1:1:1 to receive rituximab (R) with chemotherapy (CHOP), followed by rituximab monotherapy maintenance.
Odronextamab + Chemotherapy + Maintenance
EXPERIMENTALIn Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy \[CHOP, or cyclophosphamide, vincristine, and prednisone (CVP)\], followed by odronextamab monotherapy maintenance.
Odronextamab + Chemotherapy + No maintenance
EXPERIMENTALIn Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy (CHOP, or CVP) without maintenance.
Interventions
Administered by intravenous (IV) infusion
Administered by IV infusion, or subcutaneous (SC)
Administered by IV infusion
Administered by IV infusion
Administered orally (PO)
Administered by IV infusion
Eligibility Criteria
You may qualify if:
- Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV
- For Part 1A: previously untreated participants who have Follicular Lymphoma International Prognostic Index (FLIPI)-1 score of 3 to 5, or R/R FL
- For Part 1B: previously untreated participants who have FLIPI-1 score of 3 to 5
- For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5
- Have measurable disease on cross sectional imaging documented by diagnostic computed tomography \[CT\], or magnetic resonance imaging \[MRI\] imaging, as described in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate bone marrow and hepatic function.
You may not qualify if:
- Participants with central nervous system lymphoma or leptomeningeal lymphoma
- Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
- Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma
- Recent major surgery and history or organ transplantation
- A malignancy other than NHL unless the participant is adequately and definitively treated and any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (145)
Boca Raton Clinical Research (BRCR) Global
Plantation, Florida, 33322, United States
Investigative Clinical Research of Indiana
Noblesville, Indiana, 46062, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503, United States
Center for Oncology and Blood Disorders
Houston, Texas, 77030, United States
Community Cancer Trials of Utah
Ogden, Utah, 84405, United States
Prohealth Care Inc
Waukesha, Wisconsin, 53188, United States
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Pindara Private Hospital
Benowa, Queensland, 4217, Australia
Karl Landsteiner University Hospital St. Poelten
Sankt Pölten, Lower Austria, 3100, Austria
Medical University of Graz
Graz, Styria, 8036, Austria
Landeskrankenhaus Hochsteiermark
Leoben, Styria, 8700, Austria
Innsbruck Medical University
Innsbruck, Tyrol, 6020, Austria
Kepler University Hospital
Linz, Upper Austria, 4020, Austria
Universitatsklinik fur Kinder und Jungendheilkunde
Vienna, 1090, Austria
Klinikum Wels-Grieskirchen
Wels, 4600, Austria
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent, Oost-Vlaanderen, 9000, Belgium
Verenigde Ziekenhuizen van Waas en Durme
Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium
Algemeen Ziekenhuis St Jan Brugge Oostende Av
Bruges, West-Vlaanderen, 8000, Belgium
AZ Groeninge
Kortrijk, West-Vlaanderen, 8500, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
Centre Hospitalier Regional de la Citadelle
Liège, 4000, Belgium
Hospital Santa Izabel - Santa Casa de Misericordia da Bahia
Salvador, Estado de Bahia, 40050-410, Brazil
Hospital Sao Rafael
Salvador, Estado de Bahia, 41253-900, Brazil
Ensino e Terapia de Inovacao Clinica Amo (Etica)
Salvador, Estado de Bahia, 41950-640, Brazil
Hospital Sirio Libanes Brasilia
Brasília, Federal District, 70200-730, Brazil
Instituto DOr de Pesquisa e Ensino Df Star
Brasília, Federal District, 70390-140, Brazil
Instituto Mario Pena de Ensino Pesquisa e Inovacao
Belo Horizonte, Minas Gerais, 30380-472, Brazil
Centro Oncologico do Triangulo (COT) - Uberlandia
Uberlândia, Minas Gerais, 38408-008, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060, Brazil
Liga Norte Riograndense Contra o Cancer
Natal, Rio Grande do Norte, 59062-000, Brazil
Instituto Tacchini de Pesquisa em Saude
Bento Gonçalves, Rio Grande do Sul, 95700-084, Brazil
Instituto do Cancer em Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-080, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Centro de Hematologia e Oncologia
Joinville, Santa Catarina, 89201-260, Brazil
Animi Unidade de Tratamento Oncologico Ltda
Lages, Santa Catarina, 88501-001, Brazil
Fundacao Pio XII Hospital de Amor
Barretos, São Paulo, 14784-400, Brazil
Amaral Carvalho Hospital
Jaú, São Paulo, 17210-080, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Ribeirão Preto, São Paulo, 14048-900, Brazil
Instituto Nacional de Cancer Jose Alencar Gomes da Silva
Rio de Janeiro, 20231050, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, 01323-903, Brazil
AC Camargo Cancer Center
São Paulo, 01509-010, Brazil
Clinical Hospital of Medicine School at Sao Paulo University
São Paulo, 05403-000, Brazil
Casa de Saude Santa Marcelina
São Paulo, 08270-070, Brazil
Hospital Clinico Universidad de Los Andes
Santiago, Las Condes, 7620157, Chile
Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, 7550000, Chile
Centro Oncologia de Precision Universidad Mayor
Santiago, Santiago Metropolitan, 7560907, Chile
Inmunocel
Santiago, Santiago Metropolitan, 7580206, Chile
University Hospital Hradec Kralove
Hradec Králové, North Central Czech Republic, 50005, Czechia
University Hospital Brno
Brno, South Moravian, 62500, Czechia
Cannes Hospital (Centre Hospitalier Cannes Simone Veil)
Cannes, Alpes Maritimes, 06400, France
CHRU de Tours
Tours, Centre-Val de Loire, 37044, France
Institut de Cancerologie du Gard
Nîmes, Gard, 30029, France
Centre Hospitalier de Mont-de-Marsan
Mont-de-Marsan, Nouvelle-Aquitaine, 40024, France
Nantes University Hospital
Nantes, Pays de la Loire Region, 44093, France
The Novo Hospital North West Val Deoise
Cergy-Pontoise, Pontoise, 95300, France
Centre Hospitalier Universitaire de Grenoble
Grenoble, 38043, France
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43012, France
Centre Hospitalier de Lens (Centre Hospitalier Dr Schaffner dLens)
Lens, 62300, France
Hopital Saint Louis
Paris, 75010, France
Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Sud - Hôpital Haut Lévêque
Pessac, 33600, France
CHU de Saint-Etienne
Saint-Etienne, 42055, France
Centre Hospitalier de Saint Nazaire
Saint-Nazaire, 44600, France
Hopital Victor Dupouy Argenteuil
Argenteuil, Île-de-France Region, 95100, France
Stadtisches Krankenhaus Kiel
Kiel, 24116, Germany
MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
Neuss, 41462, Germany
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9103102, Israel
Soroka University Medical Center
Beersheba, 84101, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Hadassah Medical Center
Jerusalem, 91200, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Assuta Medical Centers
Tel Aviv, 6971028, Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Forli-Cesena, 47014, Italy
Azienda Ospedaliera Ordine Mauriziano Torino, Presidio Umberto I of Turin
Turin, Piedmont, 10137, Italy
Azienda Ospedaliera Universitario Policlinico Palermo
Palermo, Sicily, 90127, Italy
ASST Grande Ospedale Metropolitano Niguarda - Main Address
Milan, 20162, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
A.O.U. di Modena
Modena, 41124, Italy
Federico II University
Naples, 80131, Italy
Azienda Ospedaliera di Perugia
Perugia, 06132, Italy
University of Pisa, Section of Hematology
Pisa, 56126, Italy
Azienda Ospedaliera Regionale San Carlo
Potenza, 85100, Italy
UO Ematologia Ravenna
Ravenna, 48121, Italy
Azienda Unita Sanitaria Locale Irccs Arcispedale Santa Maria Nuova
Reggio Emilia, 42123, Italy
Azienda Osperdaliero-Universitaria Policlinico Umberto 1
Rome, 00161, Italy
Azienda Sanitaria Universitaria del Friuli Centrale
Udine, 33100, Italy
Matopolskie Centrum Medyczne S.C.
Krakow, Lesser Poland Voivodeship, 30-510, Poland
Aidport
Skorzewo, Wielkopolska, 60185, Poland
Szpital Uniwersytecki Nr2 Bydgoszcz
Bydgoszcz, 85-168, Poland
Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center
Gdansk, 80-952, Poland
Pratia Onkologia Katowice
Katowice, 40-519, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)
Lodz, 93-513, Poland
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-954, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa
Warsaw, 02781, Poland
Szpital Szpecjalistyczny w Walbrzychu
Wałbrzych, 58-300, Poland
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013, Spain
Parc Tauli Sabadell Hospital Universitari
Sabadell, Barcelona, 08208, Spain
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, 08221, Spain
Cruces University Hospital (Hospital Universitario Cruces)
Barakaldo, Bizkaia, 48903, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Universitario Quiron Salud Madrid
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital General Universitario Doctor Balmis Alicante
Alicante, Valencia, 03010, Spain
Hospital Universitario Lucus Augusti
Lugo, 27003, Spain
Clinica Universidad de Navarra - Madrid
Madrid, 28027, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Complexo Hospitalario Universitario de Ourense
Ourense, 32005, Spain
Clinica Universidad de Navarra- Pamplona
Pamplona, 31008, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Instituto Valenciano de Oncologia
Valencia, 46009, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Kaohsiung Medical University Hospital
Kaohsiung City, 80756, Taiwan
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City, 83301, Taiwan
Taipei Medical University - Shuang Ho Hospital
New Taipei City, 23561, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Taipei Medical University Multipal Wan Fang University
Taipei, 11696, Taiwan
Chulalongkorn University
Bangkok, Krung Thep Maha Nakhon [Bangko], 10330, Thailand
Khon Kaen University
Khon Kaen, 40002, Thailand
Ankara University Faculty of Medicine
Mamak, Ankara, 06620, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Yenimahalle, Ankara, 06200, Turkey (Türkiye)
Gazi University
Ankara, Central Anatolia, 06100, Turkey (Türkiye)
VM Medical Park Mersin Hospital
Mezitli, Mersin, 33200, Turkey (Türkiye)
Sakarya University
Sakarya, Serdivan, 54050, Turkey (Türkiye)
Tekirdag Namik Kemal University Hospital
Tekirdağ, Suleymanpasa, 59100, Turkey (Türkiye)
Liv Hospital Ankara
Ankara, 06100, Turkey (Türkiye)
VKV American Hopital
Istanbul, 34365, Turkey (Türkiye)
Istanbul University
Istanbul, 34418, Turkey (Türkiye)
Erci̇yes Uni̇versi̇ty
Kayseri, 38039, Turkey (Türkiye)
Ondokuz Mayıs University
Samsun, 55270, Turkey (Türkiye)
Zonguldak Bulent Ecevit University
Zonguldak, 67100, Turkey (Türkiye)
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ, United Kingdom
The Hillingdon Hospitals NHS Foundation Trust
Uxbridge, London, UB8 3NN, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2SY, United Kingdom
NHS Grampian: Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
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 18, 2023
First Posted
October 24, 2023
Study Start
November 14, 2023
Primary Completion (Estimated)
July 29, 2029
Study Completion (Estimated)
July 29, 2029
Last Updated
February 6, 2026
Record last verified: 2025-09
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
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing