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)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Follicular Lymphoma (FL)
• Intervention / Treatment: Drug: Odronextamab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone/Prenisolone; Drug: Rituximab; Drug: Vincristine

• Study Type: Interventional
• Enrollment (Estimated): 733
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital
    • Waratah, New South Wales, Australia, 2298
      • Calvary Mater Newcastle
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • Pindara Private Hospital
• Austria
  • Vienna, Austria, 1090
    • Universitatsklinik fur Kinder und Jungendheilkunde
  • Wels, Austria, 4600
    • Klinikum Wels-Grieskirchen
  • Lower Austria
    • Sankt Pölten, Lower Austria, Austria, 3100
      • Karl Landsteiner University Hospital St. Poelten
  • Styria
    • Graz, Styria, Austria, 8036
      • Medical University of Graz
    • Leoben, Styria, Austria, 8700
      • Landeskrankenhaus Hochsteiermark
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Innsbruck Medical University
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Kepler University Hospital
• Belgium
  • Brussels, Belgium, 1000
    • Institut Jules Bordet
  • Liège, Belgium, 4000
    • Centre Hospitalier Regional de la Citadelle
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
    • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
      • Verenigde Ziekenhuizen van Waas en Durme
  • West-Vlaanderen
    • Bruges, West-Vlaanderen, Belgium, 8000
      • Algemeen Ziekenhuis St Jan Brugge Oostende Av
    • Kortrijk, West-Vlaanderen, Belgium, 8500
      • AZ Groeninge
• Brazil
  • Rio de Janeiro, Brazil, 20231050
    • Instituto Nacional de Cancer Jose Alencar Gomes da Silva
  • São Paulo, Brazil, 01323-903
    • Hospital Alemao Oswaldo Cruz
  • São Paulo, Brazil, 08270-070
    • Casa de Saude Santa Marcelina
  • São Paulo, Brazil, 01509-010
    • AC Camargo Cancer Center
  • São Paulo, Brazil, 05403-000
    • Clinical Hospital of Medicine School at Sao Paulo University
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40050-410
      • Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia
    • Salvador, Estado de Bahia, Brazil, 41253-900
      • Hospital Sao Rafael
    • Salvador, Estado de Bahia, Brazil, 41950-640
      • Ensino e Terapia de Inovacao Clinica Amo (Etica)
  • Federal District
    • Brasília, Federal District, Brazil, 70200-730
      • Hospital Sirio Libanes Brasilia
    • Brasília, Federal District, Brazil, 70390-140
      • Instituto DOr de Pesquisa e Ensino Df Star
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30380-472
      • Instituto Mario Pena de Ensino Pesquisa e Inovacao
    • Uberlândia, Minas Gerais, Brazil, 38408-008
      • Centro Oncologico do Triangulo (COT) - Uberlandia
  • Paraná
    • Curitiba, Paraná, Brazil, 81520-060
      • Hospital Erasto Gaertner
  • Rio Grande do Norte
    • Natal, Rio Grande do Norte, Brazil, 59062-000
      • Liga Norte Riograndense Contra o Câncer
  • Rio Grande do Sul
    • Bento Gonçalves, Rio Grande do Sul, Brazil, 95700-084
      • Instituto Tacchini de Pesquisa em Saude
    • Passo Fundo, Rio Grande do Sul, Brazil, 99010-080
      • Instituto do Cancer em Hospital Sao Vicente de Paulo
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Hospital de Clínicas de Porto Alegre
  • Santa Catarina
    • Joinville, Santa Catarina, Brazil, 89201-260
      • Centro de Hematologia e Oncologia
    • Lages, Santa Catarina, Brazil, 88501-001
      • Animi Unidade de Tratamento Oncologico Ltda
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Fundacao Pio XII Hospital de Amor
    • Jaú, São Paulo, Brazil, 17210-080
      • Amaral Carvalho Hospital
    • Ribeirão Preto, São Paulo, Brazil, 14048-900
      • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
• Chile
  • Las Condes
    • Santiago, Las Condes, Chile, 7620157
      • Hospital Clinico Universidad de Los Andes
  • Santiago Metropolitan
    • Santiago, Santiago Metropolitan, Chile, 7550000
      • Pontificia Universidad Catolica de Chile
    • Santiago, Santiago Metropolitan, Chile, 7560907
      • Centro Oncologia de Precision Universidad Mayor
    • Santiago, Santiago Metropolitan, Chile, 7580206
      • Inmunocel
• Czechia
  • North Central Czech Republic
    • Hradec Králové, North Central Czech Republic, Czechia, 50005
      • University hospital Hradec Králové
  • South Moravian
    • Brno, South Moravian, Czechia, 62500
      • University Hospital Brno
• France
  • Grenoble, France, 38043
    • Centre Hospitalier Universitaire de Grenoble
  • Le Puy-en-Velay, France, 43012
    • Centre Hospitalier Emile Roux
  • Lens, France, 62300
    • Centre Hospitalier de Lens (Centre Hospitalier Dr Schaffner dLens)
  • Paris, France, 75010
    • Hopital Saint Louis
  • Pessac, France, 33600
    • Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Sud - Hôpital Haut Lévêque
  • Saint-Etienne, France, 42055
    • CHU de Saint-Etienne
  • Saint-Nazaire, France, 44600
    • Centre Hospitalier de Saint Nazaire
  • Alpes Maritimes
    • Cannes, Alpes Maritimes, France, 06400
      • Cannes Hospital (Centre Hospitalier Cannes Simone Veil)
  • Centre-Val de Loire
    • Tours, Centre-Val de Loire, France, 37044
      • Chru De Tours
  • Gard
    • Nîmes, Gard, France, 30029
      • Institut de cancerologie du Gard
  • Nouvelle-Aquitaine
    • Mont-de-Marsan, Nouvelle-Aquitaine, France, 40024
      • Centre Hospitalier de Mont-de-Marsan
  • Pays de la Loire Region
    • Nantes, Pays de la Loire Region, France, 44093
      • Nantes University Hospital
  • Pontoise
    • Cergy-Pontoise, Pontoise, France, 95300
      • The Novo Hospital North West Val Deoise
  • Île-de-France Region
    • Argenteuil, Île-de-France Region, France, 95100
      • Hopital Victor Dupouy Argenteuil
• Germany
  • Kiel, Germany, 24116
    • Stadtisches Krankenhaus Kiel
  • Neuss, Germany, 41462
    • MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
• Israel
  • Beersheba, Israel, 84101
    • Soroka University Medical Center
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Jerusalem, Israel, 91200
    • Hadassah Medical Center
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center
  • Tel Aviv, Israel, 64239
    • The Tel Aviv Sourasky Medical Center
  • Tel Aviv, Israel, 6971028
    • Assuta Medical Centers
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 9103102
      • Shaare Zedek Medical Center
• Italy
  • Milan, Italy, 20141
    • Istituto Europeo Di Oncologia
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Milan, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda - Main Address
  • Modena, Italy, 41124
    • A.O.U. di Modena
  • Napoli, Italy, 80131
    • Federico II University
  • Perugia, Italy, 06132
    • Azienda Ospedaliera di Perugia
  • Pisa, Italy, 56126
    • University of Pisa, Section of Hematology
  • Potenza, Italy, 85100
    • Azienda Ospedaliera Regionale San Carlo
  • Ravenna, Italy, 48121
    • UO Ematologia Ravenna
  • Reggio Emilia, Italy, 42123
    • Azienda Unita Sanitaria Locale Irccs Arcispedale Santa Maria Nuova
  • Rome, Italy, 00161
    • Azienda Osperdaliero-Universitaria Policlinico Umberto 1
  • Udine, Italy, 33100
    • Azienda Sanitaria Universitaria del Friuli Centrale
  • Forli-Cesena
    • Meldola, Forli-Cesena, Italy, 47014
      • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Piedmont
    • Turin, Piedmont, Italy, 10137
      • Azienda Ospedaliera Ordine Mauriziano Torino, Presidio Umberto I of Turin
  • Sicily
    • Palermo, Sicily, Italy, 90127
      • Azienda Ospedaliera Universitario Policlinico Palermo
• Poland
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki Nr2 Bydgoszcz
  • Gdansk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center
  • Katowice, Poland, 40-519
    • Pratia Onkologia Katowice
  • Lodz, Poland, 93-513
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)
  • Lublin, Poland, 20-954
    • Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
  • Warsaw, Poland, 02781
    • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa
  • Wałbrzych, Poland, 58-300
    • Szpital Szpecjalistyczny w Walbrzychu
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-510
      • Matopolskie Centrum Medyczne S.C.
  • Wielkopolska
    • Skorzewo, Wielkopolska, Poland, 60185
      • Aidport
• Spain
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti
  • Madrid, Spain, 28027
    • Clínica Universidad de Navarra - Madrid
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor
  • Ourense, Spain, 32005
    • Complexo Hospitalario Universitario de Ourense
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra- Pamplona
  • Salamanca, Spain, 37007
    • Hospital Universitario De Salamanca
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Valencia, Spain, 46009
    • Instituto Valenciano de Oncologia
  • Andalusia
    • Seville, Andalusia, Spain, 41013
      • Hospital Universitario Virgen del Rocio
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Parc Tauli Sabadell Hospital Universitari
    • Terrassa, Barcelona, Spain, 08221
      • Hospital Universitari Mutua Terrassa
  • Bizkaia
    • Barakaldo, Bizkaia, Spain, 48903
      • Cruces University Hospital (Hospital Universitario Cruces)
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro - Majadahonda
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Hospital Universitario Quirón Salud Madrid
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Hospital Universitario de Navarra
  • Principality of Asturias
    • Oviedo, Principality of Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias
  • Valencia
    • Alicante, Valencia, Spain, 03010
      • Hospital General Universitario Doctor Balmis Alicante
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Kaohsiung Medical University Hospital
  • Kaohsiung City, Taiwan, 83301
    • Chang Gung Memorial Hospital Kaohsiung
  • New Taipei City, Taiwan, 23561
    • Taipei Medical University - Shuang Ho Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 11490
    • Tri-Service General Hospital
  • Taipei, Taiwan, 11696
    • Taipei Medical University Multipal Wan Fang University
• Thailand
  • Khon Kaen, Thailand, 40002
    • Khon Kaen University
  • Krung Thep Maha Nakhon [Bangko]
    • Bangkok, Krung Thep Maha Nakhon [Bangko], Thailand, 10330
      • Chulalongkorn University
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06100
    • Liv Hospital Ankara
  • Istanbul, Turkey (Türkiye), 34365
    • VKV American Hopital
  • Istanbul, Turkey (Türkiye), 34418
    • Istanbul University
  • Kayseri, Turkey (Türkiye), 38039
    • Erciyes University
  • Samsun, Turkey (Türkiye), 55270
    • Ondokuz Mayıs University
  • Zonguldak, Turkey (Türkiye), 67100
    • Zonguldak Bülent Ecevit University
  • Ankara
    • Mamak, Ankara, Turkey (Türkiye), 06620
      • Ankara University Faculty of Medicine
    • Yenimahalle, Ankara, Turkey (Türkiye), 06200
      • Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
  • Central Anatolia
    • Ankara, Central Anatolia, Turkey (Türkiye), 06100
      • Gazi University
  • Mersin
    • Mezitli, Mersin, Turkey (Türkiye), 33200
      • VM Medical Park Mersin Hospital
  • Serdivan
    • Sakarya, Serdivan, Turkey (Türkiye), 54050
      • Sakarya University
  • Suleymanpasa
    • Tekirdağ, Suleymanpasa, Turkey (Türkiye), 59100
      • Tekirdag Namik Kemal University Hospital
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZN
    • NHS Grampian: Aberdeen Royal Infirmary
  • Cornwall
    • Truro, Cornwall, United Kingdom, TR1 3LJ
      • Royal Cornwall Hospital
  • London
    • Uxbridge, London, United Kingdom, UB8 3NN
      • The Hillingdon Hospitals NHS Foundation Trust
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B15 2SY
      • University Hospitals Birmingham NHS Foundation Trust
• United States
  • Florida
    • Plantation, Florida, United States, 33322
      • Boca Raton Clinical Research (BRCR) Global
  • Indiana
    • Noblesville, Indiana, United States, 46062
      • Investigative Clinical Research of Indiana
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University Of Kentucky
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Grand Rapids, Michigan, United States, 49503
      • Cancer and Hematology Centers of Western Michigan
  • Texas
    • Houston, Texas, United States, 77030
      • Center for Oncology and Blood Disorders
  • Utah
    • Ogden, Utah, United States, 84405
      • Community Cancer Trials of Utah
  • Wisconsin
    • Waukesha, Wisconsin, United States, 53188
      • Prohealth Care Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV

   1. For Part 1A: previously untreated participants who have Follicular Lymphoma International Prognostic Index (FLIPI)-1 score of 3 to 5, or R/R FL
   2. For Part 1B: previously untreated participants who have FLIPI-1 score of 3 to 5
   3. For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5
2. Have measurable disease on cross sectional imaging documented by diagnostic computed tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
4. Adequate bone marrow and hepatic function.

Key Exclusion Criteria:

1. Participants with central nervous system lymphoma or leptomeningeal lymphoma
2. Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
3. Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma
4. Recent major surgery and history or organ transplantation
5. 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.

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rituximab + Chemotherapy; In Part 2 only, participants will be randomized 1:1:1 to receive rituximab (R) with chemotherapy (CHOP), followed by rituximab monotherapy maintenance.	Drug: Odronextamab; Administered by intravenous (IV) infusion; Other Names: REGN1979; Drug: Cyclophosphamide; Administered by IV infusion; Other Names: Cytoxan; Drug: Doxorubicin; Administered by IV infusion; Other Names: Adriamycin; Drug: Prednisone/Prenisolone; Administered orally (PO); Other Names: Deltasone/Omnipred; Drug: Rituximab; Administered by IV infusion, or subcutaneous (SC); Other Names: Rituxan; Drug: Vincristine; Administered by IV infusion; Other Names: Oncovin
Experimental: Odronextamab + Chemotherapy + Maintenance; In 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.	Drug: Odronextamab; Administered by intravenous (IV) infusion; Other Names: REGN1979; Drug: Vincristine; Administered by IV infusion; Other Names: Oncovin
Experimental: Odronextamab + Chemotherapy + No maintenance; In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy (CHOP, or CVP) without maintenance.	Drug: Odronextamab; Administered by intravenous (IV) infusion; Other Names: REGN1979; Drug: Vincristine; Administered by IV infusion; Other Names: Oncovin
Experimental: Odronextamab + Chemotherapy; Part 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.	Drug: Odronextamab; Administered by intravenous (IV) infusion; Other Names: REGN1979; Drug: Cyclophosphamide; Administered by IV infusion; Other Names: Cytoxan; Drug: Doxorubicin; Administered by IV infusion; Other Names: Adriamycin; Drug: Prednisone/Prenisolone; Administered orally (PO); Other Names: Deltasone/Omnipred

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of TEAEs	Part 2	Up to 2 years
Severity of TEAEs	Part 2	Up to 2 years
CR30 as assessed by local investigator	Part 2	Up to 30 months
Time to next anti-lymphoma treatment (TTNT)	Part 2	Up to 5 years
Odronextamab concentrations in serum when administered with chemotherapy	Part 1, Maintenance period and Part 2, Induction period	Up to 30 months
Odronextamab concentrations in serum when administered as monotherapy	Part 1 and Part 2, Maintenance period	Up to 30 months
Incidence of anti-odronextamab antibodies (ADAs)	Part 1 and Part 2	Up to 30 months
Titers of ADAs to odronextamab	Part 1 and Part 2	Up to 30 months
Incidence of neutralizing antibodies (NAb) to odronextamab	Part 1 and Part 2	Up to 30 months
Best overall response (BOR) as assessed by the investigator	Part 1, end of Induction period and end of Maintenance period	Up to 30 months
Progression free survival (PFS) as assessed by ICR	Part 2	Up to 5 years
PFS as assessed by local investigator	Part 2	Up to 5 years
Event-free survival (EFS) as assessed by ICR	Part 2	Up to 5 years
EFS as assessed by local investigator	Part 2	Up to 5 years
Overall Survival (OS)	Part 2	Up to 5 years
BOR as assessed by local investigator	Part 2	Up to 30 months
BOR as assessed by ICR	Part 2	Up to 30 months
Duration of response (DOR) assessed by ICR	Part 2	Up to 5 years
DOR as assessed by local investigator	Part 2	Up to 5 years
Change in patient reported physical functioning scale scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-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.	Up to 5 years
Change in patient reported health related quality of life (HRQoL) as measured by 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 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.	Up to 5 years
Change in cancer disease as measured by 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 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.	Up to 5 years
Change in treatment related symptoms as measured by 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 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.	Up to 5 years
Change in patient-reported lymphoma disease as measured by the Lymphoma Subscale of the Functional Assessment of Cancer Treatment-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.	Up to 5 years
Change in treatment-related symptoms as measured by the FACT-LymS	Part 2 The FACT-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.	Up to 5 years
Change in patient-reported general health status per EuroQol-5 Dimensions-5 Levels (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".	Up to 5 years
Change in patient-reported treatment side effects burden per Functional Assessment of Cancer Therapy-General Global Population Item 5 (FACT-G GP5)	Part 2 A single item 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).	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).	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.	Up to 5 years
Change in score of the FACT-G GP5 item in the patient population	Part 2 A single item 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).	Up to 5 years

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• OLYMPIA

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2023
• Primary Completion (Estimated): July 29, 2029
• Study Completion (Estimated): July 29, 2029

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Odronextamab; Non-Hodgkin lymphomas (NHL); B-cells NHL (B-NHL); Relapsed or Refractory (R/R) FL; Untreated FL
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Lymphoma, Follicular; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Alkaloids; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glycosides; Indoles; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienediols; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indolizidines; Indolizines; Anthracyclines; Naphthacenes; Aminoglycosides; Antibodies, Monoclonal, Murine-Derived; Daunorubicin; Prednisolone; Rituximab; Prednisone; Cyclophosphamide; Doxorubicin; Vincristine; Methylprednisolone
• Other Study ID Numbers: R1979-ONC-2075; 2022-502113-28-00 (Other Identifier: EUCT 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

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

• IPD Sharing 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
• 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