Follicular Lymphoma (FL)Phase 3OLYMPIA-1NCT06091254
A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma
A Phase 3 study testing Odronextamab, Rituximab and Cyclophosphamide in people with Follicular Lymphoma (FL), run by Regeneron Pharmaceuticals at 190 sites in 19 countries.
Trial 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 (a type of non-Hodgkin lymphoma or NHL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma (FL)
- What is being tested?
- Odronextamab, Rituximab and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 822 participants
- Where
- 190 sitesin 19 countries
- Study dates
- 12 Dec 2023to 3 Nov 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Cluster of Differentiation 20^+ (CD20^+) FL Grade 1-3a, stage II bulky or stage III / IV
- Need for treatment as described in the protocol
- Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate bone marrow function and hepatic function, as described in the protocol
Who cannot join
- Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma
- Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
- Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
- Treatment with any systemic anti-lymphoma therapy
- Infections and allergy/hypersensitivity to study drug or excipient, as described in the protocol
- NOTE: Other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
190 sites in 19 countries. Contact the study team or a site near you to ask about taking part.
190 sites in 19 countries
Spain29 sites, 21 recruiting
- Withdrawn
Complejo Hospitalario Universitario de a Coruna
A Coruña, Galicia, 15006
- Recruiting
Cruces University Hospital (Hospital Universitario Cruces)
Barakaldo, Bizkaia, 48903
- Recruiting
University Hospital Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
- Withdrawn
Hospital Clinico Universitario Virgen De La Arrixaca
El Palmar, Murcia, 30120
- Recruiting
Hospital Virgen De Las Nieves De Granada
Granada, 18014
- Recruiting
Gregorio Maranon
Madrid, 28007
- Withdrawn
Clinica Universidad de Navarra
Madrid, 28027
- Recruiting
Clinica Universidad de Navarra
Madrid, 28027
- Recruiting
Fundacion Jimenez Diaz University Hospital
Madrid, 28040
- Recruiting
University Hospital & Research Institute
Madrid, 28041
- Recruiting
Hospital Universitario HM Sanchinarro, Servicio de Hematologia
Madrid, 28050
- Recruiting
Hospital Universitario Virgen De La Victoria Malaga
Málaga, Andalusia, 29010
- Recruiting
Morales Meseguer Hospital
Murcia, 30008
- Withdrawn
Complexo Hospitalario Universitario de Ourense
Ourense, 32005
- Withdrawn
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
- Withdrawn
Son Espases University Hospital
Palma, Balearic Islands, 07120
- Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
- Recruiting
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223
- Recruiting
Hospital Universitario de Salamanca
Salamanca, 37007
- Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
- Recruiting
University Hospital of Santiago de Compostela
Santiago de Compostela, A Coruna, 15706
- Recruiting
Hospital Universitario Virgen Macarena
Seville, Andalusia, 41009
- Recruiting
University Hospital Virgen del Rocio
Seville, 41013
- Recruiting
Hospital Universitario Virgen de Valme
Seville, 41014
- Withdrawn
Hospital General Universitario de Toledo
Toledo, 45007
- Withdrawn
Hospital Clinico Universitario Valencia
Valencia, 46010
- Recruiting
Hospital Universitari and Politecnic La Fe
Valencia, 46026
- Recruiting
Hospital Clinico Lozano Blesa
Zaragoza, 50009
United States20 sites, 14 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27514
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28207
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
- Completed
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
- Recruiting
Center for Oncology and Blood Disorders
Houston, Texas, 77030
- Recruiting
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
- Recruiting
Icahn School of Medicine at Mt Sinai
New York, New York, 10029
- Recruiting
Investigative Clinical Research of Indiana
Noblesville, Indiana, 46062
- Withdrawn
UC Irvine Health
Orange, California, 92868
- Withdrawn
Virginia Commonwealth University
Richmond, Virginia, 23219
- Recruiting
Huntsman Cancer Institute - Oncology Division
Salt Lake City, Utah, 84112
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
- Recruiting
University of Arizona Cancer Center
Tucson, Arizona, 85724
- Withdrawn
HOPE Cancer Center of East Texas
Tyler, Texas, 75701
- Withdrawn
Prohealth Care Inc
Waukesha, Wisconsin, 53188
- Withdrawn
Clinical Research Alliance Inc
Westbury, New York, 11590
Brazil17 sites, 16 recruiting
- Recruiting
Fundacao Pio XII Hospital de Amor
Barretos, São Paulo, 14784-400
- Recruiting
Instituto Mario Pena de Ensino Pesquisa e Inovacao
Belo Horizonte, Minas Gerais, 30380-420
- Recruiting
Instituto DOr de Pesquisa e Ensino Df Star
Brasília, 70390-140
- Recruiting
Amaral Carvalho Hospital
Jaú, São Paulo, 17210080
- Recruiting
Centro de Hematologia e Oncologia
Joinville, Santa Catarina, 89201260
- Recruiting
Animi Unidade de Tratamento Oncologico Ltda
Lages, Santa Catarina, 88501-001
- Recruiting
Liga Norte Riograndense Contra o Cancer
Natal, Rio Grande do Norte, 59062-000
- Recruiting
Instituto do Cancer em Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-080
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
- Recruiting
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirão Preto, São Paulo, 14048-900
- Withdrawn
Instituto Nacional de Cancer Jose Alencar Gomes da Silva
Rio de Janeiro, 20231050
- Recruiting
Instituto Americas
Rio de Janeiro, 22793-334
- Recruiting
Ensino e Terapia de Inovacao Clinica Amo (Etica)
Salvador, Estado de Bahia, 41950640
- Recruiting
Hospital Alemao Oswaldo Cruz
São Paulo, 01323-903
- Recruiting
AC Camargo Cancer Center
São Paulo, 01509010
- Recruiting
Clinical Hospital of Medicine School at Sao Paulo University
São Paulo, 05403-000
- Recruiting
Casa de Saude Santa Marcelina
São Paulo, 08270-070
Italy13 sites, 10 recruiting
- Withdrawn
UOC Ematologia e Terapia Cellulare - PO Mazzoni AST Ascoli Piceno
Ascoli Piceno, 63100
- Withdrawn
Irccs Aou Di Bologna - Policlinico Di Sant'orsola Malpighi
Bologna, 40138
- Recruiting
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
- Recruiting
Candiolo Cancer Institute, FPO, IRCCS
Candiolo, Torino, 10060
- Recruiting
IRCCS Ospedale Policlinico San Martino
Genoa, Liguria, 16132
- Recruiting
Istituto Romagnolo Per Lo Studio Dei Tumori
Meldola, Forli Cesena, 47014
- Recruiting
Istituto Europeo di Oncologia
Milan, 20141
- Completed
Federico II University
Naples, 80131
- Recruiting
AOU Maggiore della Carita-SCDU Ematologia
Novara, 28100
- Recruiting
UO Ematologia Ravenna
Ravenna, 48121
- Recruiting
Pia Fondazione Panico
Tricase, Lecce, 73039
- Recruiting
Santa Maria della Misericordia
Udine, 33100
- Recruiting
Ospedale dell'Angelo - Varese
Varese, 21100
Turkey (Türkiye)13 sites, 8 recruiting
- Recruiting
Gazi University
Ankara, Central Anatolia, 06100
- Withdrawn
Liv Hospital Ankara
Ankara, 06100
- Recruiting
VKV American Hopital
Istanbul, 34365
- Recruiting
Istanbul University Istanbul Faculty of Medicine
Istanbul, 34418
- Recruiting
Ege University
Izmir, 35100
- Recruiting
Erci̇yes Uni̇versi̇ty
Kayseri, 38039
- Withdrawn
Ankara University Faculty of Medicine
Mamak, Ankara, 06620
- Withdrawn
VM Medical Park Mersin Hospital
Mezitli, Mersin, 33200
- Recruiting
Sakarya University Medical Faculty
Sakarya, 54290
- Withdrawn
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55239
- Recruiting
Tekirdag Namik Kemal University Hospital
Tekirdağ, Suleymanpasa, 59100
- Recruiting
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Yenimahalle, Ankara, 06200
- Withdrawn
Zonguldak Bulent Ecevit University
Zonguldak, 67100
France12 sites, 10 recruiting
- Recruiting
Centre Hospitalier Universitaire Angers
Angers, 49933
- Recruiting
Hopital Victor Dupouy Argenteuil
Argenteuil, Île-de-France Region, 95100
- Recruiting
Hopital de la Conception
Marseille, Provence-Alpes-Côte d'Azur Region, 13005
- Recruiting
Institut Paoli Calmettes
Marseille, 13009
- Withdrawn
Nantes University Hospital
Nantes, Pays de la Loire Region, 44093
- Recruiting
Hopital Saint Louis
Paris, 75010
- Recruiting
Hopital Saint-Antoine
Paris, 755710
- Withdrawn
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, Vienne, 86021
- Recruiting
Centre Hospitalier Universitaire (CHU) Rennes
Rennes, Brittany Region, 35033
- Recruiting
Institut de Cancerologie Strasbourg Europe (ICANS)
Strasbourg, 67033
- Recruiting
Centre Hospitalier Regional Universitaire de Tours
Tours, Centre-Val de Loire, 37044
- Recruiting
Gustave Roussy
Villejuif, Île-de-France Region, 94800
Taiwan12 sites, 10 recruiting
- Withdrawn
Chang Gung Medical Foundation Chia Yi Branch
Buzi, Chiayi County, 613
- Recruiting
Changhua Christian Hospital
Changhua, 500-06
- Recruiting
Chung-Ho Memorial Hospital
Kaohsiung City, 80756
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
- Recruiting
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 235
- Recruiting
Taichung General Veterans Hospital
Taichung, 40705
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
- Recruiting
National Taiwan University Hospital
Taipei, 100225
- Completed
Taipei Veterans General Hospital
Taipei, 11217
- Recruiting
Tri-Service General Hospital
Taipei, 114
- Recruiting
Taipei Municipal Wan Fang Hospital
Taipei, 116
- Recruiting
Chang Gung Memorial Hospital Linkou
Taoyuan City, Guishan District, 333
Poland10 sites, 7 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-952
- Recruiting
Pratia Onkologia Katowice
Katowice, 40-519
- Recruiting
Pratia MCM Krakow
Krakow, Malopolska, 30-510
- Withdrawn
Copernicus Memorial Hospital
Lodz, 93-513
- Recruiting
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-954
- Recruiting
Aidport Sp. z o.o.
Skorzewo, Wielkopolska, 60185
- Completed
Cm Pratia Poznan
Skorzewo, Wielkopolska, 60185
- Recruiting
Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu
Wałbrzych, Lower Silesian Voivodeship, 58-309
- Withdrawn
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa
Warsaw, 02781
- Recruiting
Uniwersytecki Szpital Kliniczny
Wroclaw, Lower Silesian Voivodeship, 50-367
Germany9 sites, 7 recruiting
- Recruiting
Charite Universitatsmedizin Berlin Campus Benjamin Franklin
Berlin, 12203
- Recruiting
Hematological Praxis Dresden
Dresden, Saxony, 01307
- Recruiting
University Hospital Carl Gustav Carus
Dresden, 01307
- Withdrawn
Clinic Frankfurt (Oder)
Frankfurt am Main, Hesse, 15236
- Recruiting
Stadtisches Krankenhaus Kiel
Kiel, 24116
- Recruiting
Universitatsmedizin der Johannes-Gutenberg Universitat Mainz
Mainz, Rhineland-Palatinate, 55131
- Recruiting
Kliniken Ostalb Stauferklinikum Schwab Gmund
Mutlangen, Gmund, D-73557
- Withdrawn
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg, 70376
- Recruiting
University Hospital Wurzburg
Würzburg, Bavaria, 97080
South Korea8 sites, 3 recruiting
- Completed
Dong-A University Hospital
Busan, 49201
- Recruiting
Pusan National University Hospital
Busan, 49241
- Withdrawn
Kyungpook National University Chilgok Hospital
Daegu, 41404
- Withdrawn
Center for Hematologic Malignancy
Goyang-si, Gyeonggi-do, 10408
- Withdrawn
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
- Withdrawn
Seoul St. Mary's Hospital
Seoul, 06591
- Recruiting
St. Vincents Hospital - The Catholic University of Korea
Suwon, Gyeonggi-do, 16247
- Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
Australia7 sites, 6 recruiting
- Completed
Icon Cancer Centre - Wesley
Auchenflower, Queensland, 4066
- Recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5042
- Recruiting
Monash Health
Clayton, Victoria, 3168
- Recruiting
Epworth Freemasons
East Melbourne, Victoria, 3121
- Recruiting
Ingham Institute
Liverpool, New South Wales, 2170
- Recruiting
Alfred Hospital and Monash University
Melbourne, Victoria, 3004
- Recruiting
St Vincents Hospital Melbourne
Melbourne, Victoria, 3065
Israel7 sites, 7 recruiting
- Recruiting
Samson Assuta Ashdod University Hospital
Ashdod, 7747629
- Recruiting
Bnai Zion Medical Center
Haifa, 31048
- Recruiting
Hadassah Medical Center
Jerusalem, 91200
- Recruiting
Galilee Medical Center
Nahariya, 2210001
- Recruiting
Rabin Medical Center
Petah Tikva, 4941492
- Recruiting
Chaim Sheba Medical Center
Ramat Gan, 5265601
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
United Kingdom6 sites, 5 recruiting
- Recruiting
University Hospitals Dorset
Bournemouth, Dorset, BH77DW
- Recruiting
Beatson West of Scotland Cancer Centre
Glasgow, Lanarkshire, G12 0YN
- Recruiting
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UY
- Withdrawn
Derriford Hospital and the Royal Eye Infirmary
Plymouth, Devon, PL6 8DH
- Recruiting
Barking, Havering and Redbridge University Hospitals NHS Trust
Romford, RM7 0AG
- Recruiting
Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ
Austria5 sites, 5 recruiting
- Recruiting
Ordensklinikum Linz
Linz, Osterreich, 4010
- Recruiting
Ordensklinikum Linz Gmbh, Elisabethinen
Linz, 4020
- Recruiting
Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III
Salzburg, 5020
- Recruiting
Medical University of Vienna
Vienna, 1090
- Recruiting
Hanusch Krankenhaus
Vienna, 1140
Belgium5 sites
- Withdrawn
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, 2060
- Withdrawn
Institut Jules Bordet
Brussels, 1000
- Withdrawn
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent, Oost-Vlaanderen, 9000
- Withdrawn
AZ St.-Elisabeth Herentals vzw
Herentals, Antwerp, 2200
- Withdrawn
Hopital De Jolimont
La Louvière, Hainaut, 7100
Canada5 sites, 5 recruiting
- Recruiting
Tom Baker Cancer Center
Calgary, Alberta, T2N 4J8
- Recruiting
Centre Integre de Sante et de Services Sociaux (CISSS) de la Monteregie-Centre
Greenfield Park, Quebec, J4V 2H1
- Recruiting
CHU de Quebec - Universite Laval
Québec, Quebec, G1J1Z4
- Recruiting
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
- Recruiting
Ciusss de Lestrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, J1H 5N4
Switzerland5 sites, 5 recruiting
- Recruiting
Kantonsspital Baden
Baden, Canton of Aargau, 5404
- Recruiting
University Hospital Basel
Basel, 4031
- Recruiting
Inselspital Bern University Hospital
Bern, 3010
- Recruiting
Cantonal Hospital St Gallen
Sankt Gallen, Canton of St. Gallen, 9007
- Recruiting
Kantonsspital Winterthur Medical Oncology
Winterthur, Schweiz, 8401
Chile4 sites, 3 recruiting
- Recruiting
Fundacion Arturo Lopez Perez
Santiago, Santiago Metropolitan, 7500921
- Withdrawn
Centro Oncologia de Precision Universidad Mayor
Santiago, Santiago Metropolitan, 7560907
- Recruiting
Inmunocel
Santiago, Santiago Metropolitan, 7580206
- Recruiting
Clinica Alemana de Santiago
Santiago, Santiago Metropolitan, 7650620
Czechia3 sites, 3 recruiting
- Recruiting
University Hospital Hradec Kralove
Hradec Králové, 50005
- Recruiting
University Hospital Kralovske Vinohrady
Prague, 10034
- Recruiting
Vseobecna Fakultni Nemocnice
Prague, 12808
About this study
Official title: A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)
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 (a type of non-Hodgkin lymphoma or NHL).
This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled).
Read more
The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone.
The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") 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)
- How the study drug affects quality of life and ability to complete routine daily activities.
- Conditions
- Follicular Lymphoma (FL)
- Being tested
- Odronextamab, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
- Keywords
- Non-Hodgkin lymphomas (NHLs), Indolent NHL, B-cells NHL (B-NHL), Follicular lymphoma, Odronextamab
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OdronextamabDrug
Also called REGN1979
Administered per the protocol
RituximabDrug
Also called Rituxan
Administered per the protocol
CyclophosphamideDrug
Also called Cytoxan
Administered per the protocol as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy
DoxorubicinDrug
Also called Adriamycin
Administered per the protocol as part of CHOP chemotherapy
VincristineDrug
Also called Oncovin
Administered per the protocol as part of CHOP, and CVP chemotherapy
Prednisone/prednisoloneDrug
Also called Deltasone/Omnipred
Administered per the protocol as part of CVP chemotherapy
BendamustineDrug
Also called Treanda
Administered per the protocol as part of chemotherapy (Rituximab-Bendamustine)
| Study group | Role | What they receive |
|---|---|---|
| Odronextamab | Experimental | Part 1 is a safety run-in. All participants will receive odronextamab.
In part 2 participants will be randomly assigned in a 1:1 ratio to receive odronextamab followed by odronextamab maintenance. Receives: Drug: Odronextamab |
| Rituximab + Investigator's Choice Chemotherapy | Active comparator | Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance. Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone/prednisolone; Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs) for odronextamab
Part 1
Measured: Up to 35 days
Incidence of Treatment-Emergent Adverse Events (TEAEs) of odronextamab
Part 1
Measured: Up to 2 years
Severity of TEAEs of odronextamab
Part 1
Measured: Up to 2 years
Complete Response at 30 months (CR30) as assessed by independent central review
Part 2
Measured: Up to 30 months
Secondary outcomes (28)
Concentrations of odronextamab in serum
Part 1
Measured: Up to 30 months
Occurrence of Anti-Drug Antibodies (ADAs) to odronextamab
Part 1
Measured: Up to 30 months
Magnitude of ADAs to odronextamab
Part 1
Measured: Up to 30 months
Objective response as assessed by the investigator
Part 1
Measured: Up to 30 months
Progression-Free Survival (PFS) as assessed by independent central review
Part 2
Measured: Up to 5 years
Event-Free Survival (EFS) as assessed by independent central review
Part 2
Measured: Up to 5 years
Overall Survival (OS)
Part 2
Measured: Up to 5 years
Overall mean change in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)]
Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a global health status (GHS)/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.
Measured: Up to 5 years
CR30 as assessed by local investigator
Part 2
Measured: Up to 30 months
PFS as assessed by the local investigator
Part 2
Measured: Up to 5 years
EFS as assessed by the local investigator
Part 2
Measured: Up to 5 years
Objective response assessed by local investigator
Part 2
Measured: Up to 30 months
Objective response assessed by independent central review
Part 2
Measured: Up to 30 months
Duration Of Response (DOR) assessed by independent central review
Part 2
Measured: Up to 5 years
DOR assessed by local investigator
Part 2
Measured: Up to 5 years
Time To Next anti-lymphoma Treatment (TTNT)
Part 2
Measured: Up to 5 years
Incidence of TEAEs
Part 2
Measured: Up to 2 years
Severity of TEAEs
Part 2
Measured: Up to 2 years
Odronextamab concentrations in serum during the induction period
Part 2
Measured: Up to 30 months
Odronextamab concentrations in serum during the maintenance period
Part 2
Measured: Up to 30 months
Occurrence of ADAs to odronextamab
Part 2
Measured: Up to 30 months
Magnitude of ADAs to odronextamab
Part 2
Measured: Up to 30 months
Overall mean changes in scores of patient reported outcomes (PROs), as measured by the validated instruments EORTCQLQ- C30
Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a global health status (GHS)/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.
Measured: Up to 5 years
Overall mean changes in scores of PROs, as measured by the validated instruments Functional Assessment of Cancer Therapy-Lymphoma (FACT-LymS)
Part 2 The FACT-Lym lymphoma subscale (LymS) includes 15 items to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). Higher scores are associated with a worse quality of life.
Measured: Up to 5 years
Overall mean changes in scores of PROs, as measured by the validated instruments EuroQol-5 Dimension-5 Level Scale (EQ-5D- 5L)
Part 2 The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: "no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems". The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labeled "Best imaginable health state" and "Worst imaginable health state".
Measured: Up to 5 years
Change in Patient Global Impression of Severity (PGIS)
Part 2 The PGIS includes a single-item to assess how a patient perceives the overall severity of cancer symptoms over the past 7 days. Patients will choose the response that best describes the severity of their overall cancer symptoms with options on a 5-point scale ranging from 1 (No symptoms) to 4 (Very Severe).
Measured: Up to 5 years
Change in Patient Global Impression of Change (PGIC)
Part 2 The PGIC item includes a single-item to assess how a patient perceives their overall change in health status since the start of study treatment. Patients will choose from response options on a 7-point scale ranging from 1 (Much Better) to 7 (Much worse); 1- Much Better, 2-Moderately Better, 3-A Little Better, 4-About the Same, 5-A Little Worse, 6-Moderately Worse, 7-Much Worse.
Measured: Up to 5 years
Change in score of the GP5 item in the participant population
Part 2 A single item Global Population item 5 (GP5) of the validated FACT-G questionnaire will be used to assess from the participant perspective the overall impact of treatment side-effect. The question item is on a 5-point scale ranging from "not at all" (0) to "very much" (4).
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start12 Dec 2023
- Primary completion7 Feb 2028 (estimated)
- Study completion3 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular Lymphoma (FL)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 822 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091254
- Sponsor's protocol ID
- R1979-HM-2298
- Other IDs
- 2022-502660-20-00
- Acronym
- OLYMPIA-1
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.