AzTrials
AzTrials

Relapsed/Refractory Follicular LymphomaPhase 3OLYMPIA-5NCT06149286

A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma

A Phase 3 study testing Odronextamab, Lenalidomide and Rituximab in people with Relapsed/Refractory Follicular Lymphoma and Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL), run by Regeneron Pharmaceuticals at 171 sites in 18 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) that has come back after treatment (called "relapsed") or… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Odronextamab, Lenalidomide and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
580 participants
Where
171 sitesin 18 countries
Study dates
28 Dec 2023to 30 Apr 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra nodal MZL) as assessed by the investigator, as described in the protocol.
  • Must have refractory disease or relapsed after at least 1 prior line (with a duration of at least 2 cycles) of systemic chemo-immunotherapy or immunotherapy. Prior systemic therapy should have included at least one anti-Cluster of Differentiation 20 (CD20) monoclonal antibody, and participant should meet indication for treatment, as described in the protocol.
  • 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 to 2.
  • Adequate hematologic and organ function, as described in the protocol.
  • All study participants must:
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  • Have an understanding that lenalidomide could have a potential teratogenic risk.
  • Agree to abstain from donating blood while taking study drug therapy and for 28 days after discontinuation of lenalidomide.
  • Agree not to share study medication with another person.
  • Agree to be counseled about pregnancy precautions and risk of fetal exposure associated with lenalidomide.

Who cannot join

  • Primary Central Nervous System (CNS) lymphoma or known involvement (either current or prior history of CNS involvement) by non-primary CNS NHL, as described in the protocol.
  • Participants with current or past histological evidence of high-grade or diffuse large B-cell lymphoma, or any histology other than FL grade 1-3a or MZL.
  • History of or current relevant CNS pathology, as described in the protocol.
  • A malignancy other than NHL (inclusion diagnosis) unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer treated with hormone therapy or local radiotherapy (ie, pellets), cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated.
  • 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.
  • Allergy/hypersensitivity to study drugs or excipients. as described in the protocol.
  • Active infection as defined in the protocol.
  • Note: Other protocol-defined Inclusion/Exclusion criteria apply

Trial locations and contacts

171 sites in 18 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

171 sites in 18 countries

Italy18 sites, 18 recruiting

  • Centro Di Riferimento Oncologico (CRO), Aviano, National Cancer Institute

    Aviano, Pordenone, 33081

    Recruiting

  • University of Bologna Dipartimento di Medicina Specialistica Diagnostica e Sperimentale

    Bologna, 40138

    Recruiting

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123

    Recruiting

  • Candiolo Cancer Institute, FPO, IRCCS

    Candiolo, Torino, 10060

    Recruiting

  • Ospedale Policlinico San Martino IRCCS

    Genoa, Genova, 16132

    Recruiting

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, Forli-Cesena, 47014

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda - Main Address

    Milan, 20162

    Recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

    Recruiting

  • Istituto Europeo di Oncologia

    Milan, 20141

    Recruiting

  • A.O.U. di Modena

    Modena, 41124

    Recruiting

  • S Gerardo Hospital

    Monza, Monza E Brianza, 20900

    Recruiting

  • Federico II University

    Naples, 80131

    Recruiting

  • AOU Maggiore della Carita

    Novara, 28100

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

    Recruiting

  • Azienda Ospedaliera di Perugia

    Perugia, 06132

    Recruiting

  • Ospedale Santa Maria delle Croci

    Ravenna, 48121

    Recruiting

  • A.O.U. Citta della Salute e della Scienza di Torino

    Turin, Piedmont, 10126

    Recruiting

  • Santa Maria della Misericordia

    Udine, 33100

    Recruiting

Other trials in Italy

Spain18 sites, 18 recruiting

  • University Hospital Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

    Recruiting

  • Hospital Virgen De Las Nieves De Granada

    Granada, 18014

    Recruiting

  • Institut Catala d'Oncologia

    L'Hospitalet de Llobregat, Barcelona, 08908

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

    Recruiting

  • Fundacion Jimenez Diaz University Hospital

    Madrid, 28040

    Recruiting

  • Hospital Universitario12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

    Recruiting

  • Son Espases University Hospital

    Palma, Balearic Islands, 07120

    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

  • University Hospital Virgen del Rocio

    Seville, 41013

    Recruiting

  • Instituto Valenciano de Oncologia

    Valencia, 46009

    Recruiting

  • University Hospital Doctor Peset

    Valencia, 46017

    Recruiting

Other trials in Spain

France17 sites, 17 recruiting

  • Hopital Victor Dupouy Argenteuil

    Argenteuil, Île-de-France Region, 95100

    Recruiting

  • Centre Hospitalier d'Avignon

    Avignon, 84000

    Recruiting

  • Avicenne Hospital

    Bobigny, Île-de-France Region, 93000

    Recruiting

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, Gironde, 33077

    Recruiting

  • Centre Hospitalier Metropole Savoie

    Chambéry, Savoie, 73000

    Recruiting

  • Hopital Saint Vincent-de-Paul

    Lille, Nord, 5900

    Recruiting

  • Institut Paoli-Calmettes

    Marseille, Bouches Du Rhone, 13009

    Recruiting

  • Centre Hospitalier Universitaire (CHU) Montpellier

    Montpellier, 34290

    Recruiting

  • Nantes University Hospital

    Nantes, Pays de la Loire Region, 44093

    Recruiting

  • Hopital Saint Louis

    Paris, 75010

    Recruiting

  • Assistance Publique-Hopitaux de Paris (AP-HP)

    Paris, 75571

    Recruiting

  • Centre Francois Magendie

    Pessac, Gironde, 33600

    Recruiting

  • CHU de Rennes

    Rennes, Brittany Region, 35033

    Recruiting

  • Centre Henri Becquerel

    Rouen, Normandy, 76038

    Recruiting

  • Institut Curie

    Saint-Cloud, 92210

    Recruiting

  • Centre Hospitalier Regional Universitaire de Tours

    Tours, Centre-Val de Loire, 37044

    Recruiting

  • Gustave Roussy

    Villejuif, Île-de-France Region, 94800

    Recruiting

Other trials in France

South Korea13 sites, 12 recruiting

  • Inje University Busan Paik Hospital

    Busan, 47392

    Recruiting

  • Pusan National University Hospital

    Busan, 49241

    Recruiting

  • Yeyungnam University Medical Center

    Daegu, 42415

    Withdrawn

  • Gachon University Gil Medical Center

    Incheon, Namdong-Gu, 21565

    Recruiting

  • Jeonbuk National University Hospital

    Jeonju, Jeollabuk, 54907

    Recruiting

  • Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • Yeouido St. Marys Hospital

    Seoul, 07345

    Recruiting

  • Seoul St Marys Hospital

    Seoul, 137-701

    Recruiting

  • Seoul National University Hospital

    Seoul, 3080

    Recruiting

  • St. Vincents Hospital - The Catholic University of Korea

    Suwon, Gyeonggi-do, 16247

    Recruiting

  • Ulsan University Hospital

    Ulsan, 44033

    Recruiting

Other trials in South Korea

Poland12 sites, 10 recruiting

  • In-Vivo Sp. z o.o.

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048

    Recruiting

  • Szpital Uniwersytecki Nr2 Bydgoszcz

    Bydgoszcz, 85-168

    Withdrawn

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-952

    Recruiting

  • Pratia Onkologia Katowice

    Katowice, 40-519

    Recruiting

  • Pratia MCM Krakow

    Krakow, Malopolska, 30-510

    Recruiting

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)

    Lodz, 93-513

    Recruiting

  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie, Centrum Innowacyjnych Terapii

    Lublin, Lublin Voivodeship, 20-090

    Recruiting

  • Pratia Poznan Medical Center

    Poznan, Wielkopolska, 60185

    Completed

  • Aidport Sp. z o.o.

    Skorzewo, Wielkopolska, 60185

    Recruiting

  • Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu

    Wałbrzych, Lower Silesian Voivodeship, 58-309

    Recruiting

  • Narodowy Instytut Onkologii

    Warsaw, 02-781

    Recruiting

  • Uniwersytecki Szpital Kliniczny

    Wroclaw, Lower Silesian Voivodeship, 50-367

    Recruiting

Other trials in Poland

Taiwan12 sites, 12 recruiting

  • Chang Gung Medical Foundation Chia Yi Branch

    Buzi, Chiayi County, 613

    Recruiting

  • Changhua Christian Hospital

    Changhua, 500-06

    Recruiting

  • Show Chwan Memorial Hospital

    Changhua, 50008

    Recruiting

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80756

    Recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

    Recruiting

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City, 23561

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 701

    Recruiting

  • National Taiwan University Hospital

    Taipei, 10002

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

  • Tri-Service General Hospital

    Taipei, 11490

    Recruiting

  • Taipei Municipal Wan Fang Hospital

    Taipei, 116

    Recruiting

  • Chang Gung Memorial Hospital

    Taoyuan City, 333

    Recruiting

Other trials in Taiwan

Turkey (Türkiye)11 sites, 11 recruiting

  • Gazi University

    Ankara, Central Anatolia, 06100

    Recruiting

  • Istanbul University, Istanbul Medical Faculty

    Istanbul, 34093

    Recruiting

  • Ege University

    Izmir, 35100

    Recruiting

  • Dokuz Eylul University

    Izmir, 35340

    Recruiting

  • Ankara University Faculty of Medicine

    Mamak, Ankara, 06620

    Recruiting

  • VM Medical Park Mersin Hospital

    Mezitli, Mersin, 33200

    Recruiting

  • Sakarya University Medical Faculty

    Sakarya, 54290

    Recruiting

  • Ondokuz Mayıs University

    Samsun, 55270

    Recruiting

  • Tekirdag Namik Kemal University Hospital

    Tekirdağ, Suleymanpasa, 59100

    Recruiting

  • Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Yenimahalle, Ankara, 06200

    Recruiting

  • Zonguldak Bulent Ecevit University

    Zonguldak, 67600

    Recruiting

Other trials in Turkey (Türkiye)

Brazil10 sites, 10 recruiting

  • Hospital Sirio Libanes Brasilia

    Brasília, Federal District, 70200-730

    Recruiting

  • Uopeccan Hospital do Cancer de Cascavel

    Cascavel, Paraná, 85806-300

    Recruiting

  • Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

    Recruiting

  • Amaral Carvalho Hospital

    Jaú, São Paulo, 17210-080

    Recruiting

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

    Recruiting

  • Centro Gaucho Integrado

    Porto Alegre, Rio Grande do Sul, 90110-270

    Recruiting

  • Instituto Nacional de Cancer Jose Alencar Gomes da Silva

    Rio de Janeiro, 20231050

    Recruiting

  • Hospital Sao Rafael

    Salvador, Estado de Bahia, 40285-000

    Recruiting

  • Hospital Sirio Libanes

    São Paulo, 01308-050

    Recruiting

  • A Beneficencia Portuguesa de Sao Paulo, Oncology House

    São Paulo, 01321000

    Recruiting

Other trials in Brazil

Germany10 sites, 10 recruiting

  • University Hospital Essen

    Essen, North Rhine-Westphalia, 45122

    Recruiting

  • Clinic Frankfurt (Oder)

    Frankfurt am Main, Hesse, 15236

    Recruiting

  • University Hospital Halle Saale

    Halle, 6120

    Recruiting

  • Stadtisches Krankenhaus Kiel

    Kiel, 24116

    Recruiting

  • Universitatsmedizin der Johannes-Gutenberg Universitat Mainz

    Mainz, Rhineland-Palatinate, 55131

    Recruiting

  • LMU Klinikum

    Munich, Bavaria, 80337

    Recruiting

  • TUM Fakultat fur Medizin - Klinikum Rechts der Isar

    Munich, Bavaria, 81675

    Recruiting

  • Stauferklinikum

    Mutlangen, Baden-Wurttemberg, 73557

    Recruiting

  • MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH

    Neuss, 41462

    Recruiting

  • Robert-Bosch-Krankenhaus

    Stuttgart, Baden-Wurttemberg, 70376

    Recruiting

Other trials in Germany

United Kingdom9 sites, 9 recruiting

  • University Hospitals Dorset

    Bournemouth, Dorset, BH7 7DW

    Recruiting

  • James Paget University Hospitals NHS Foundation Trust

    Great Yarmouth, NR31 6LA

    Recruiting

  • Derriford Hospital and the Royal Eye Infirmary

    Plymouth, Devon, PL6 8DH

    Recruiting

  • Barking, Havering and Redbridge University Hospitals NHS Trust

    Romford, RM7 0AG

    Recruiting

  • Salisbury Foundation Trust

    Salisbury, Hampshire, SP6 2ND

    Recruiting

  • The Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

    Recruiting

  • Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LJ

    Recruiting

  • The Hillingdon Hospital

    Uxbridge, Middlesex, UB8 3NN

    Recruiting

  • South Warwickshire NHS Foundation Trust

    Warwick, CV34 5BW

    Recruiting

Other trials in United Kingdom

United States8 sites, 7 recruiting

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

    Recruiting

  • Indiana University and Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

    Recruiting

  • Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

    Recruiting

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095

    Recruiting

  • Boca Raton Clinical Research (BRCR) Global

    Plantation, Florida, 33322

    Recruiting

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

    Recruiting

  • Prohealth Care Inc

    Waukesha, Wisconsin, 53188

    Recruiting

  • Clinical Research Alliance Inc

    Westbury, New York, 11590

    Withdrawn

Other trials in United States

Israel7 sites, 7 recruiting

  • Assuta Ashdod Medical Center

    Ashdod, 7747629

    Recruiting

  • Hadassah Medical Center

    Jerusalem, 91200

    Recruiting

  • Galilee Medical Center

    Nahariya, 2210001

    Recruiting

  • Rabin Medical Center

    Petah Tikva, 49100

    Recruiting

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601

    Recruiting

  • The Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

    Recruiting

  • Assuta Medical Centers

    Tel Aviv, 6971028

    Recruiting

Other trials in Israel

Australia5 sites, 5 recruiting

  • Pindara Private Hospital

    Benowa, Queensland, 4217

    Recruiting

  • Epworth Freemasons

    East Melbourne, Victoria, 3121

    Recruiting

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

    Recruiting

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

    Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

    Recruiting

Other trials in Australia

Belgium5 sites, 5 recruiting

  • Ziekenhuis Netwerk Antwerpen Stuivenberg

    Antwerp, 2060

    Recruiting

  • Institut Jules Bordet

    Brussels, 1000

    Recruiting

  • Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital

    Ghent, Oost-Vlaanderen, 9000

    Recruiting

  • Algemeen Ziekenhuis AZ Delta

    Roeselare, West-Vlaanderen, 8800

    Recruiting

  • Centre Hospitalier Universitaire at Universite Catholique de Louvain Namur

    Yvoir, Namur, 5530

    Recruiting

Other trials in Belgium

Malaysia5 sites, 5 recruiting

  • Hospital Ampang

    Ampang, Selangor, 68000

    Recruiting

  • Hospital Sultanah Aminah Jhor Bahru

    Johor Bahru, Johor, 80100

    Recruiting

  • Hospital Queen Elizabeth

    Kota Kinabalu, Sabah, 88586

    Recruiting

  • University of Malaya Medical Centre

    Kuala Lumpur, Negeri / Wilayah Persekutuan, 50603

    Recruiting

  • Subang Jaya Medical Center

    Subang Jaya, Selangor, 47500

    Recruiting

Other trials in Malaysia

Austria4 sites, 4 recruiting

  • Ordensklinikum Linz

    Linz, Osterreich, 4020

    Recruiting

  • Kepler University Hospital

    Linz, Upper Austria, 4020

    Recruiting

  • Medical University Vienna

    Vienna, 1090

    Recruiting

  • Klinikum Wels-Grieskirchen

    Wels, 4600

    Recruiting

Other trials in Austria

Czechia4 sites, 4 recruiting

  • Fakultni Nemocnice Brno

    Brno, 62500

    Recruiting

  • University Hospital Hradec Kralove

    Hradec Králové, East Bohemia, 50005

    Recruiting

  • University Hospital Kralovske Vinohrady

    Prague, 10034

    Recruiting

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, 12808

    Recruiting

Other trials in Czechia

Thailand3 sites, 3 recruiting

  • Chulalongkorn University

    Bangkok, Krung Thep Maha Nakhon [Bangko], 10330

    Recruiting

  • Sriraj Hospital

    Bangkok, 10700

    Recruiting

  • Chiang Mai University

    Chiang Mai, 50200

    Recruiting

Other trials in Thailand

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, in Combination With Lenalidomide Versus Rituximab in Combination With Lenalidomide in Relapsed/Refractory Participants With Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)

This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's Lymphoma (NHL).

This study will be made up of two parts (Part 1 not randomized, 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 used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before.

The aim of Part 2, of the study is to assess how well the combination of the study drug and lenalidomide works compared to the combination of rituximab (called "the comparator drug") and lenalidomide. The combination of comparator drug and lenalidomide is the current standard-of-care treatment for relapsed/refractory FL and/or MZL. 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 in combination with lenalidomide
  • 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
Being tested
Odronextamab, Lenalidomide, Rituximab
Keywords
Relapsed/Refractory Follicular Lymphoma, Relapsed/Refractory Marginal Zone Lymphoma, Non-Hodgkin lymphomas, Indolent lymphomas, Odronextamab
Medical subject headings
Lymphoma, Follicular, Recurrence, Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OdronextamabDrug

    Also called REGN1979, Ordspono

    Administered per the protocol

  • LenalidomideDrug

    Also called REVLIMID

    Administered per the protocol

  • RituximabDrug

    Also called Rituxan

    Administered per the protocol

Study groups in NCT06149286
Study groupRoleWhat they receive
Odronextamab+LenalidomideExperimentalIn part 1 (safety run-in), participants with R/R indolent lymphoma (FL and MZL), will receive odronextamab in combination with lenalidomide. In part 2, 1:1 randomized participants with R/R FL and MZL, will receive odronextamab in combination with lenalidomide.
Receives: Drug: Odronextamab; Drug: Lenalidomide
Rituximab+LenalidomideExperimentalIn part 2 only, 1:1 randomized participants with R/R FL and ML, will receive rituximab in combination with lenalidomide (R2) followed by lenalidomide monotherapy.
Receives: Drug: Lenalidomide; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Dose Limiting Toxicities (DLTs) for odronextamab in combination with lenalidomide

    Part 1

    Measured: Up to 35 days

  2. Incidence of Treatment Emergent Adverse Events (TEAEs) for odronextamab in combination with lenalidomide

    Part 1

    Measured: Up to 2 years

  3. Severity of TEAEs for odronextamab in combination with lenalidomide

    Part 1

    Measured: Up to 2 years

  4. Progression-Free Survival (PFS) as assessed by Independent Central Review (ICR)

    Part 2

    Measured: Up to 5 years

Secondary outcomes (21)

  1. Odronextamab concentrations in serum

    Part 1 and Part 2

    Measured: Up to 30 months

  2. Incidence of Anti-Drug Antibodies (ADA) to odronextamab

    Part 1 and Part 2

    Measured: Up to 30 months

  3. Magnitude of ADAs to odronextamab

    Part 1 and Part 2

    Measured: Up to 30 months

  4. Best Overall Response (BOR) as assessed by investigator review

    Part 1 and Part 2

    Measured: Up to 30 months

  5. Duration of Response (DOR) as assessed by investigator review

    Part 1 and Part 2

    Measured: Up to 5 years

  6. PFS as assessed by investigator review

    Part 1 and Part 2

    Measured: Up to 5 years

  7. Complete Response (CR) as assessed by ICR

    Part 2

    Measured: Up to 30 months

  8. BOR as assessed by ICR

    Part 2

    Measured: Up to 30 months

  9. Overall Survival (OS)

    Part 2

    Measured: Up to 5 years

  10. Event Free Survival (EFS) as assessed by ICR

    Part 2

    Measured: Up to 5 years

  11. EFS as assessed by local investigator review

    Part 2

    Measured: Up to 5 years

  12. DOR as assessed by ICR

    Part 2

    Measured: Up to 5 years

  13. Time To Next anti-lymphoma Treatment (TTNT)

    Part 2

    Measured: Up to 5 years

  14. Incidence of TEAEs for odronextamab in combination with lenalidomide versus R2

    Part 2

    Measured: Up to 2 years

  15. Severity of TEAEs for odronextamab in combination with lenalidomide versus R2

    Part 2

    Measured: Up to 2 years

  16. Overall change in Patient Reported Outcomes (PROs) as measured by scores of European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQC30)

    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 GHS/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

  17. Overall change in PROs as measured by scores of Functional Assessment of Cancer Therapy-Lymphoma Subscale (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

  18. Overall change in PROs as measured by scores of 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".

    Measured: Up to 5 years

  19. Change from first assessment in Patient Global Impression on 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

  20. Change from first assessment in Patient Global Impression on 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

  21. Change from first assessment in the Global Population item 5 (GP5) items of the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire

    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).

    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.

  1. First posted28 Nov 2023
  2. Study start28 Dec 2023
  3. Primary completion30 Apr 2031 (estimated)
  4. Study completion30 Apr 2031 (estimated)

Resources

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
580 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06149286
Sponsor's protocol ID
R1979-ONC-22102
Other IDs
2022-503092-28-00
Acronym
OLYMPIA-5
Status last verified
Oct 2026
First submitted
20 Nov 2023
Last updated
7 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Odronextamab, Lenalidomide and Rituximab in people with Relapsed/Refractory Follicular Lymphoma and Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL), run by Regeneron Pharmaceuticals at 171 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 171 sites in Italy, Spain, France, South Korea, Poland and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose Limiting Toxicities (DLTs) for odronextamab in combination with lenalidomide (time frame: Up to 35 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06149286.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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