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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
NCT06149286 · Regeneron Pharmaceuticals
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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)
About this study
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
Eligibility criteria
Key Inclusion Criteria:
1. 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.
2. 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.
3. Have measurable disease on cross sectional imaging documented by diagnostic Computed Tomography \[CT\], or Magnetic Resonance Imaging \[MRI\] imaging, as described in the protocol.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
5. Adequate hematologic and organ function, as described in the protocol.
6. All study participants must:
1. Have an understanding that lenalidomide could have a potential teratogenic risk.
2. Agree to abstain from donating blood while taking study drug therapy and for 28 days after discontinuation of lenalidomide.
3. Agree not to share study medication with another person.
4. Agree to be counseled about pregnancy precautions and risk of fetal exposure associated with lenalidomide.
Key Exclusion Criteria:
1. 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.
2. 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.
3. History of or current relevant CNS pathology, as described in the protocol.
4. 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.
5. 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.
6. Allergy/hypersensitivity to study drugs or excipients. as described in the protocol.
7. Active infection as defined in the protocol.
Note: Other protocol-defined Inclusion/Exclusion criteria apply
Study design
Enrollment target: 470 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-12-28
Estimated completion: 2029-01-23
Last updated: 2026-04-13
Interventions
Drug: OdronextamabDrug: LenalidomideDrug: Rituximab
Primary outcomes
- • Incidence of Dose Limiting Toxicities (DLTs) for odronextamab in combination with lenalidomide (Up to 35 days)
- • Incidence of Treatment Emergent Adverse Events (TEAEs) for odronextamab in combination with lenalidomide (Up to 2 years)
- • Severity of TEAEs for odronextamab in combination with lenalidomide (Up to 2 years)
Sponsor
Regeneron Pharmaceuticals · industry
Contacts & investigators
ContactClinical Trials Administrator · contact · clinicaltrials@regeneron.com · 844-734-6643
InvestigatorClinical Trial Management · study_director, Regeneron Pharmaceuticals
All locations (169)
David Geffen School of Medicine at UCLARecruiting
Los Angeles, California, United States
Boca Raton Clinical Research (BRCR) GlobalRecruiting
Plantation, Florida, United States
Indiana University and Comprehensive Cancer CenterRecruiting
Indianapolis, Indiana, United States
Hattiesburg ClinicRecruiting
Hattiesburg, Mississippi, United States
Dartmouth Cancer CenterRecruiting
Lebanon, New Hampshire, United States
Stony Brook University HospitalRecruiting
Stony Brook, New York, United States
Clinical Research Alliance IncWithdrawn
Westbury, New York, United States
Prohealth Care IncRecruiting
Waukesha, Wisconsin, United States
Liverpool HospitalRecruiting
Liverpool, New South Wales, Australia
Calvary Mater NewcastleRecruiting
Waratah, New South Wales, Australia
Pindara Private HospitalRecruiting
Benowa, Queensland, Australia
Royal Hobart HospitalRecruiting
Hobart, Tasmania, Australia
Epworth FreemasonsRecruiting
East Melbourne, Victoria, Australia
Ordensklinikum LinzRecruiting
Linz, Osterreich, Austria
Kepler University HospitalRecruiting
Linz, Upper Austria, Austria
Medical University ViennaRecruiting
Vienna, Austria
Klinikum Wels-GrieskirchenRecruiting
Wels, Austria
Centre Hospitalier Universitaire at Universite Catholique de Louvain NamurRecruiting
Yvoir, Namur, Belgium
Universitair Ziekenhuis (UZ) Gent/ Ghent University HospitalRecruiting
Ghent, Oost-Vlaanderen, Belgium
Algemeen Ziekenhuis AZ DeltaRecruiting
Roeselare, West-Vlaanderen, Belgium
Ziekenhuis Netwerk Antwerpen StuivenbergRecruiting
Antwerp, Belgium
Institut Jules BordetRecruiting
Brussels, Belgium
Hospital Sao RafaelRecruiting
Salvador, Estado de Bahia, Brazil
Hospital Sirio Libanes BrasiliaRecruiting
Brasília, Federal District, Brazil
Uopeccan Hospital do Cancer de CascavelRecruiting
Cascavel, Paraná, Brazil
Hospital Erasto GaertnerRecruiting
Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto AlegreRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Centro Gaucho IntegradoRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Amaral Carvalho HospitalRecruiting
Jaú, São Paulo, Brazil
Instituto Nacional de Cancer Jose Alencar Gomes da SilvaRecruiting
Rio de Janeiro, Brazil
Hospital Sirio LibanesRecruiting
São Paulo, Brazil
A Beneficencia Portuguesa de Sao Paulo, Oncology HouseRecruiting
São Paulo, Brazil
University Hospital Hradec KraloveRecruiting
Hradec Králové, East Bohemia, Czechia
Fakultni Nemocnice BrnoRecruiting
Brno, Czechia
University Hospital Kralovske VinohradyRecruiting
Prague, Czechia
Vseobecna Fakultni Nemocnice V PrazeRecruiting
Prague, Czechia
Institut Paoli-CalmettesRecruiting
Marseille, Bouches Du Rhone, France
CHU de RennesRecruiting
Rennes, Brittany Region, France
Centre Hospitalier Regional Universitaire de ToursRecruiting
Tours, Centre-Val de Loire, France
Polyclinique Bordeaux Nord AquitaineRecruiting
Bordeaux, Gironde, France
Centre Francois MagendieRecruiting
Pessac, Gironde, France
Hopital Saint Vincent-de-PaulRecruiting
Lille, Nord, France
Centre Henri BecquerelRecruiting
Rouen, Normandy, France
Nantes University HospitalRecruiting
Nantes, Pays de la Loire Region, France
Centre Hospitalier Metropole SavoieRecruiting
Chambéry, Savoie, France
Centre Hospitalier d'AvignonRecruiting
Avignon, France
Centre Hospitalier Universitaire (CHU) MontpellierRecruiting
Montpellier, France
Hopital Saint LouisRecruiting
Paris, France
Assistance Publique-Hopitaux de Paris (AP-HP)Recruiting
Paris, France
Institut CurieRecruiting
Saint-Cloud, France
Hopital Victor Dupouy ArgenteuilRecruiting
Argenteuil, Île-de-France Region, France
Avicenne HospitalRecruiting
Bobigny, Île-de-France Region, France
Gustave RoussyRecruiting
Villejuif, Île-de-France Region, France
StauferklinikumRecruiting
Mutlangen, Baden-Wurttemberg, Germany
Robert-Bosch-KrankenhausRecruiting
Stuttgart, Baden-Wurttemberg, Germany
LMU KlinikumRecruiting
Munich, Bavaria, Germany
TUM Fakultat fur Medizin - Klinikum Rechts der IsarRecruiting
Munich, Bavaria, Germany
Clinic Frankfurt (Oder)Recruiting
Frankfurt am Main, Hesse, Germany
Universitatsmedizin der Johannes-Gutenberg Universitat MainzRecruiting
Mainz, Rhineland-Palatinate, Germany
University Hospital Halle SaaleRecruiting
Halle, Germany
Stadtisches Krankenhaus KielRecruiting
Kiel, Germany
MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbHRecruiting
Neuss, Germany
Assuta Ashdod Medical CenterActive Not Recruiting
Ashdod, Israel
Hadassah Medical CenterActive Not Recruiting
Jerusalem, Israel
Galilee Medical CenterActive Not Recruiting
Nahariya, Israel
Rabin Medical CenterActive Not Recruiting
Petah Tikva, Israel
Chaim Sheba Medical CenterRecruiting
Ramat Gan, Israel
The Tel Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
Assuta Medical CentersActive Not Recruiting
Tel Aviv, Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei TumoriRecruiting
Meldola, Forli-Cesena, Italy
Ospedale Policlinico San Martino IRCCSRecruiting
Genoa, Genova, Italy
S Gerardo HospitalRecruiting
Monza, Monza E Brianza, Italy
A.O.U. Citta della Salute e della Scienza di TorinoRecruiting
Turin, Piedmont, Italy
Centro Di Riferimento Oncologico (CRO), Aviano, National Cancer InstituteRecruiting
Aviano, Pordenone, Italy
Candiolo Cancer Institute, FPO, IRCCSRecruiting
Candiolo, Torino, Italy
University of Bologna Dipartimento di Medicina Specialistica Diagnostica e SperimentaleRecruiting
Bologna, Italy
Azienda Ospedaliera Spedali Civili di BresciaRecruiting
Brescia, Italy
ASST Grande Ospedale Metropolitano Niguarda - Main AddressRecruiting
Milan, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoRecruiting
Milan, Italy
Istituto Europeo di OncologiaRecruiting
Milan, Italy
A.O.U. di ModenaRecruiting
Modena, Italy
Federico II UniversityRecruiting
Naples, Italy
AOU Maggiore della CaritaRecruiting
Novara, Italy
Fondazione IRCCS Policlinico San MatteoRecruiting
Pavia, Italy
Azienda Ospedaliera di PerugiaRecruiting
Perugia, Italy
Ospedale Santa Maria delle CrociRecruiting
Ravenna, Italy
Santa Maria della MisericordiaRecruiting
Udine, Italy
Hospital Sultanah Aminah Jhor BahruRecruiting
Johor Bahru, Johor, Malaysia
University of Malaya Medical CentreRecruiting
Kuala Lumpur, Negeri / Wilayah Persekutuan, Malaysia
Hospital Queen ElizabethRecruiting
Kota Kinabalu, Sabah, Malaysia
Hospital AmpangRecruiting
Ampang, Selangor, Malaysia
Subang Jaya Medical CenterRecruiting
Subang Jaya, Selangor, Malaysia
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Wałbrzych, Lower Silesian Voivodeship, Poland
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Wroclaw, Lower Silesian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie, Centrum Innowacyjnych TerapiiRecruiting
Lublin, Lublin Voivodeship, Poland
Pratia MCM KrakowRecruiting
Krakow, Malopolska, Poland
Uniwersyteckie Centrum KliniczneRecruiting
Gdansk, Pomeranian Voivodeship, Poland
Pratia Poznan Medical CenterCompleted
Poznan, Wielkopolska, Poland
AidportRecruiting
Skorzewo, Wielkopolska, Poland
Szpital Uniwersytecki Nr2 BydgoszczWithdrawn
Bydgoszcz, Poland
Pratia Onkologia KatowiceRecruiting
Katowice, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)Recruiting
Lodz, Poland
Narodowy Instytut OnkologiiRecruiting
Warsaw, Poland
St. Vincents Hospital - The Catholic University of KoreaRecruiting
Suwon, Gyeonggi-do, South Korea
Jeonbuk National University HospitalRecruiting
Jeonju, Jeollabuk, South Korea
Gachon University Gil Medical CenterRecruiting
Incheon, Namdong-Gu, South Korea
Inje University Busan Paik HospitalRecruiting
Busan, South Korea
Pusan National University HospitalRecruiting
Busan, South Korea
Yeyungnam University Medical CenterWithdrawn
Daegu, South Korea
Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Yeouido St. Marys HospitalRecruiting
Seoul, South Korea
Seoul St Marys HospitalRecruiting
Seoul, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Ulsan University HospitalRecruiting
Ulsan, South Korea
University Hospital of Santiago de CompostelaRecruiting
Santiago de Compostela, A Coruna, Spain
Son Espases University HospitalRecruiting
Palma, Balearic Islands, Spain
Institut Catala d'OncologiaRecruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marques de ValdecillaRecruiting
Santander, Cantabria, Spain
Hospital Universitario Quironsalud MadridRecruiting
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Central de AsturiasRecruiting
Oviedo, Principality of Asturias, Spain
University Hospital Vall d'HebronRecruiting
Barcelona, Spain
Hospital Clinic de BarcelonaRecruiting
Barcelona, Spain
Hospital de la Santa Creu i Sant PauRecruiting
Barcelona, Spain
Hospital Virgen De Las Nieves De GranadaRecruiting
Granada, Spain
Hospital Universitario Ramon y CajalRecruiting
Madrid, Spain
Fundacion Jimenez Diaz University HospitalRecruiting
Madrid, Spain
Hospital Universitario12 de OctubreRecruiting
Madrid, Spain
Hospital Universitario HM SanchinarroRecruiting
Madrid, Spain
Hospital Universitario de SalamancaRecruiting
Salamanca, Spain
University Hospital Virgen del RocioRecruiting
Seville, Spain
Instituto Valenciano de OncologiaRecruiting
Valencia, Spain
University Hospital Doctor PesetRecruiting
Valencia, Spain
Chang Gung Medical Foundation Chia Yi BranchRecruiting
Buzi, Chiayi County, Taiwan
Changhua Christian HospitalRecruiting
Changhua, Taiwan
Show Chwan Memorial HospitalRecruiting
Changhua, Taiwan
Kaohsiung Medical University HospitalRecruiting
Kaohsiung City, Taiwan
Chang Gung Memorial Hospital KaohsiungRecruiting
Kaohsiung City, Taiwan
Taipei Medical University - Shuang Ho HospitalRecruiting
New Taipei City, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Tri-Service General HospitalRecruiting
Taipei, Taiwan
Taipei Municipal Wan Fang HospitalRecruiting
Taipei, Taiwan
Chang Gung Memorial HospitalRecruiting
Taoyuan, Taiwan
Chulalongkorn UniversityRecruiting
Bangkok, Krung Thep Maha Nakhon [Bangko], Thailand
Sriraj HospitalRecruiting
Bangkok, Thailand
Chiang Mai UniversityRecruiting
Chiang Mai, Thailand
Ankara University Faculty of MedicineRecruiting
Mamak, Ankara, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Oncology Training and Research HospitalRecruiting
Yenimahalle, Ankara, Turkey (Türkiye)
Gazi UniversityRecruiting
Ankara, Central Anatolia, Turkey (Türkiye)
VM Medical Park Mersin HospitalRecruiting
Mezitli, Mersin, Turkey (Türkiye)
Tekirdag Namik Kemal University HospitalRecruiting
Tekirdağ, Suleymanpasa, Turkey (Türkiye)
Istanbul University, Istanbul Medical FacultyRecruiting
Istanbul, Turkey (Türkiye)
Ege UniversityRecruiting
Izmir, Turkey (Türkiye)
Dokuz Eylul UniversityRecruiting
Izmir, Turkey (Türkiye)
Sakarya University Medical FacultyRecruiting
Sakarya, Turkey (Türkiye)
Ondokuz Mayıs UniversityRecruiting
Samsun, Turkey (Türkiye)
Zonguldak Bulent Ecevit UniversityRecruiting
Zonguldak, Turkey (Türkiye)
Royal Cornwall Hospitals NHS TrustRecruiting
Truro, Cornwall, United Kingdom
Derriford Hospital and the Royal Eye InfirmaryRecruiting
Plymouth, Devon, United Kingdom
University Hospitals DorsetRecruiting
Bournemouth, Dorset, United Kingdom
Salisbury Foundation TrustRecruiting
Salisbury, Hampshire, United Kingdom
The Hillingdon HospitalRecruiting
Uxbridge, Middlesex, United Kingdom
The Royal Marsden NHS Foundation TrustRecruiting
Sutton, Surrey, United Kingdom
James Paget University Hospitals NHS Foundation TrustRecruiting
Great Yarmouth, United Kingdom
Barking, Havering and Redbridge University Hospitals NHS TrustRecruiting
Romford, United Kingdom
South Warwickshire NHS Foundation TrustRecruiting
Warwick, United Kingdom