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
OLYMPIA-5
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)
2 other identifiers
interventional
470
17 countries
164
Brief 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 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). 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2023
Longer than P75 for phase_3
164 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2023
CompletedFirst Posted
Study publicly available on registry
November 28, 2023
CompletedStudy Start
First participant enrolled
December 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 23, 2029
May 6, 2026
May 1, 2026
5.1 years
November 20, 2023
May 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Incidence of Dose Limiting Toxicities (DLTs) for odronextamab in combination with lenalidomide
Part 1
Up to 35 days
Incidence of Treatment Emergent Adverse Events (TEAEs) for odronextamab in combination with lenalidomide
Part 1
Up to 2 years
Severity of TEAEs for odronextamab in combination with lenalidomide
Part 1
Up to 2 years
Progression-Free Survival (PFS) as assessed by Independent Central Review (ICR) in participants with R/R FL and participants with indolent lymphoma
Part 2
Up to 5 years
Secondary Outcomes (21)
Odronextamab concentrations in serum
Up to 30 months
Incidence of Anti-drug Antibodies (ADA) to odronextamab
Up to 30 months
Magnitude of ADAs to odronextamab
Up to 30 months
Best Overall Response (BOR) as assessed by investigator review
Up to 30 months
Duration of Response (DOR) as assessed by investigator review
Up to 5 years
- +16 more secondary outcomes
Study Arms (2)
Odronextamab+Lenalidomide
EXPERIMENTALIn 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 indolent lymphoma (FL/MZL), will receive odronextamab in combination with lenalidomide.
Rituximab+Lenalidomide
EXPERIMENTALIn part 2 only, 1:1 randomized participants with R/R lymphoma (FL and ML), will receive rituximab in combination with lenalidomide (R2) followed by lenalidomide monotherapy.
Interventions
Administered per the protocol
Administered per the protocol
Eligibility Criteria
You may qualify if:
- 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:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (169)
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095, United States
Boca Raton Clinical Research (BRCR) Global
Plantation, Florida, 33322, United States
Indiana University and Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Clinical Research Alliance Inc
Westbury, New York, 11590, United States
Prohealth Care Inc
Waukesha, Wisconsin, 53188, United States
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Pindara Private Hospital
Benowa, Queensland, 4217, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Epworth Freemasons
East Melbourne, Victoria, 3121, Australia
Ordensklinikum Linz
Linz, Osterreich, 4020, Austria
Kepler University Hospital
Linz, Upper Austria, 4020, Austria
Medical University Vienna
Vienna, 1090, Austria
Klinikum Wels-Grieskirchen
Wels, 4600, Austria
Centre Hospitalier Universitaire at Universite Catholique de Louvain Namur
Yvoir, Namur, 5530, Belgium
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent, Oost-Vlaanderen, 9000, Belgium
Algemeen Ziekenhuis AZ Delta
Roeselare, West-Vlaanderen, 8800, Belgium
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, 2060, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
Hospital Sao Rafael
Salvador, Estado de Bahia, 40285-000, Brazil
Hospital Sirio Libanes Brasilia
Brasília, Federal District, 70200-730, Brazil
Uopeccan Hospital do Cancer de Cascavel
Cascavel, Paraná, 85806-300, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Centro Gaucho Integrado
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Amaral Carvalho Hospital
Jaú, São Paulo, 17210-080, Brazil
Instituto Nacional de Cancer Jose Alencar Gomes da Silva
Rio de Janeiro, 20231050, Brazil
Hospital Sirio Libanes
São Paulo, 01308-050, Brazil
A Beneficencia Portuguesa de Sao Paulo, Oncology House
São Paulo, 01321000, Brazil
University Hospital Hradec Kralove
Hradec Králové, East Bohemia, 50005, Czechia
Fakultni Nemocnice Brno
Brno, 62500, Czechia
University Hospital Kralovske Vinohrady
Prague, 10034, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, 12808, Czechia
Institut Paoli-Calmettes
Marseille, Bouches Du Rhone, 13009, France
CHU de Rennes
Rennes, Brittany Region, 35033, France
Centre Hospitalier Regional Universitaire de Tours
Tours, Centre-Val de Loire, 37044, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, Gironde, 33077, France
Centre Francois Magendie
Pessac, Gironde, 33600, France
Hopital Saint Vincent-de-Paul
Lille, Nord, 5900, France
Centre Henri Becquerel
Rouen, Normandy, 76038, France
Nantes University Hospital
Nantes, Pays de la Loire Region, 44093, France
Centre Hospitalier Metropole Savoie
Chambéry, Savoie, 73000, France
Centre Hospitalier d'Avignon
Avignon, 84000, France
Centre Hospitalier Universitaire (CHU) Montpellier
Montpellier, 34290, France
Hopital Saint Louis
Paris, 75010, France
Assistance Publique-Hopitaux de Paris (AP-HP)
Paris, 75571, France
Institut Curie
Saint-Cloud, 92210, France
Hopital Victor Dupouy Argenteuil
Argenteuil, Île-de-France Region, 95100, France
Avicenne Hospital
Bobigny, Île-de-France Region, 93000, France
Gustave Roussy
Villejuif, Île-de-France Region, 94800, France
Stauferklinikum
Mutlangen, Baden-Wurttemberg, 73557, Germany
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg, 70376, Germany
LMU Klinikum
Munich, Bavaria, 80337, Germany
TUM Fakultat fur Medizin - Klinikum Rechts der Isar
Munich, Bavaria, 81675, Germany
Clinic Frankfurt (Oder)
Frankfurt am Main, Hesse, 15236, Germany
Universitatsmedizin der Johannes-Gutenberg Universitat Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
University Hospital Halle Saale
Halle, 6120, Germany
Stadtisches Krankenhaus Kiel
Kiel, 24116, Germany
MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
Neuss, 41462, Germany
Assuta Ashdod Medical Center
Ashdod, 7747629, Israel
Hadassah Medical Center
Jerusalem, 91200, Israel
Galilee Medical Center
Nahariya, 2210001, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Assuta Medical Centers
Tel Aviv, 6971028, Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Forli-Cesena, 47014, Italy
Ospedale Policlinico San Martino IRCCS
Genoa, Genova, 16132, Italy
S Gerardo Hospital
Monza, Monza E Brianza, 20900, Italy
A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont, 10126, Italy
Centro Di Riferimento Oncologico (CRO), Aviano, National Cancer Institute
Aviano, Pordenone, 33081, Italy
Candiolo Cancer Institute, FPO, IRCCS
Candiolo, Torino, 10060, Italy
University of Bologna Dipartimento di Medicina Specialistica Diagnostica e Sperimentale
Bologna, 40138, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123, Italy
ASST Grande Ospedale Metropolitano Niguarda - Main Address
Milan, 20162, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
A.O.U. di Modena
Modena, 41124, Italy
Federico II University
Naples, 80131, Italy
AOU Maggiore della Carita
Novara, 28100, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Azienda Ospedaliera di Perugia
Perugia, 06132, Italy
Ospedale Santa Maria delle Croci
Ravenna, 48121, Italy
Santa Maria della Misericordia
Udine, 33100, Italy
Hospital Sultanah Aminah Jhor Bahru
Johor Bahru, Johor, 80100, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, Negeri / Wilayah Persekutuan, 50603, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, Sabah, 88586, Malaysia
Hospital Ampang
Ampang, Selangor, 68000, Malaysia
Subang Jaya Medical Center
Subang Jaya, Selangor, 47500, Malaysia
Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu
Wałbrzych, Lower Silesian Voivodeship, 58-309, Poland
Uniwersytecki Szpital Kliniczny
Wroclaw, Lower Silesian Voivodeship, 50-367, Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie, Centrum Innowacyjnych Terapii
Lublin, Lublin Voivodeship, 20-090, Poland
Pratia MCM Krakow
Krakow, Malopolska, 30-510, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-952, Poland
Pratia Poznan Medical Center
Poznan, Wielkopolska, 60185, Poland
Aidport
Skorzewo, Wielkopolska, 60185, Poland
Szpital Uniwersytecki Nr2 Bydgoszcz
Bydgoszcz, 85-168, Poland
Pratia Onkologia Katowice
Katowice, 40-519, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)
Lodz, 93-513, Poland
Narodowy Instytut Onkologii
Warsaw, 02-781, Poland
St. Vincents Hospital - The Catholic University of Korea
Suwon, Gyeonggi-do, 16247, South Korea
Jeonbuk National University Hospital
Jeonju, Jeollabuk, 54907, South Korea
Gachon University Gil Medical Center
Incheon, Namdong-Gu, 21565, South Korea
Inje University Busan Paik Hospital
Busan, 47392, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Yeyungnam University Medical Center
Daegu, 42415, South Korea
Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Yeouido St. Marys Hospital
Seoul, 07345, South Korea
Seoul St Marys Hospital
Seoul, 137-701, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
University Hospital of Santiago de Compostela
Santiago de Compostela, A Coruna, 15706, Spain
Son Espases University Hospital
Palma, Balearic Islands, 07120, Spain
Institut Catala d'Oncologia
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
University Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Virgen De Las Nieves De Granada
Granada, 18014, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Fundacion Jimenez Diaz University Hospital
Madrid, 28040, Spain
Hospital Universitario12 de Octubre
Madrid, 28041, Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
University Hospital Virgen del Rocio
Seville, 41013, Spain
Instituto Valenciano de Oncologia
Valencia, 46009, Spain
University Hospital Doctor Peset
Valencia, 46017, Spain
Chang Gung Medical Foundation Chia Yi Branch
Buzi, Chiayi County, 613, Taiwan
Changhua Christian Hospital
Changhua, 500-06, Taiwan
Show Chwan Memorial Hospital
Changhua, 50008, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, 80756, Taiwan
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City, 83301, Taiwan
Taipei Medical University - Shuang Ho Hospital
New Taipei City, 23561, Taiwan
National Cheng Kung University Hospital
Tainan, 701, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Taipei Municipal Wan Fang Hospital
Taipei, 116, Taiwan
Chang Gung Memorial Hospital
Taoyuan City, 333, Taiwan
Chulalongkorn University
Bangkok, Krung Thep Maha Nakhon [Bangko], 10330, Thailand
Sriraj Hospital
Bangkok, 10700, Thailand
Chiang Mai University
Chiang Mai, 50200, Thailand
Ankara University Faculty of Medicine
Mamak, Ankara, 06620, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Yenimahalle, Ankara, 06200, Turkey (Türkiye)
Gazi University
Ankara, Central Anatolia, 06100, Turkey (Türkiye)
VM Medical Park Mersin Hospital
Mezitli, Mersin, 33200, Turkey (Türkiye)
Tekirdag Namik Kemal University Hospital
Tekirdağ, Suleymanpasa, 59100, Turkey (Türkiye)
Istanbul University, Istanbul Medical Faculty
Istanbul, 34093, Turkey (Türkiye)
Ege University
Izmir, 35100, Turkey (Türkiye)
Dokuz Eylul University
Izmir, 35340, Turkey (Türkiye)
Sakarya University Medical Faculty
Sakarya, 54290, Turkey (Türkiye)
Ondokuz Mayıs University
Samsun, 55270, Turkey (Türkiye)
Zonguldak Bulent Ecevit University
Zonguldak, 67600, Turkey (Türkiye)
Royal Cornwall Hospitals NHS Trust
Truro, Cornwall, TR1 3LJ, United Kingdom
Derriford Hospital and the Royal Eye Infirmary
Plymouth, Devon, PL6 8DH, United Kingdom
University Hospitals Dorset
Bournemouth, Dorset, BH7 7DW, United Kingdom
Salisbury Foundation Trust
Salisbury, Hampshire, SP6 2ND, United Kingdom
The Hillingdon Hospital
Uxbridge, Middlesex, UB8 3NN, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, NR31 6LA, United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust
Romford, RM7 0AG, United Kingdom
South Warwickshire NHS Foundation Trust
Warwick, CV34 5BW, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2023
First Posted
November 28, 2023
Study Start
December 28, 2023
Primary Completion (Estimated)
January 23, 2029
Study Completion (Estimated)
January 23, 2029
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
- Access Criteria
- Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.