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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
Sponsor: Regeneron Pharmaceuticals
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
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
580
Start Date
2023-12-28
Completion Date
2031-04-30
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
Odronextamab
Administered per the protocol
Lenalidomide
Administered per the protocol
Rituximab
Administered per the protocol
Locations (171)
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Boca Raton Clinical Research (BRCR) Global
Plantation, Florida, United States
Indiana University and Comprehensive Cancer Center
Indianapolis, Indiana, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Dartmouth Cancer Center
Lebanon, New Hampshire, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Clinical Research Alliance Inc
Westbury, New York, United States
Prohealth Care Inc
Waukesha, Wisconsin, United States
Liverpool Hospital
Liverpool, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Epworth Freemasons
East Melbourne, Victoria, Australia
Ordensklinikum Linz
Linz, Osterreich, Austria
Kepler University Hospital
Linz, Upper Austria, Austria
Medical University Vienna
Vienna, Austria
Klinikum Wels-Grieskirchen
Wels, Austria
Centre Hospitalier Universitaire at Universite Catholique de Louvain Namur
Yvoir, Namur, Belgium
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent, Oost-Vlaanderen, Belgium
Algemeen Ziekenhuis AZ Delta
Roeselare, West-Vlaanderen, Belgium
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, Belgium
Institut Jules Bordet
Brussels, Belgium
Hospital Sao Rafael
Salvador, Estado de Bahia, Brazil
Hospital Sirio Libanes Brasilia
Brasília, Federal District, Brazil
Uopeccan Hospital do Cancer de Cascavel
Cascavel, Paraná, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Centro Gaucho Integrado
Porto Alegre, Rio Grande do Sul, Brazil
Amaral Carvalho Hospital
Jaú, São Paulo, Brazil
Instituto Nacional de Cancer Jose Alencar Gomes da Silva
Rio de Janeiro, Brazil
Hospital Sirio Libanes
São Paulo, Brazil
A Beneficencia Portuguesa de Sao Paulo, Oncology House
São Paulo, Brazil
University Hospital Hradec Kralove
Hradec Králové, East Bohemia, Czechia
Fakultni Nemocnice Brno
Brno, Czechia
University Hospital Kralovske Vinohrady
Prague, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, Czechia
Institut Paoli-Calmettes
Marseille, Bouches Du Rhone, France
CHU de Rennes
Rennes, Brittany Region, France
Centre Hospitalier Regional Universitaire de Tours
Tours, Centre-Val de Loire, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, Gironde, France
Centre Francois Magendie
Pessac, Gironde, France
Hopital Saint Vincent-de-Paul
Lille, Nord, France
Centre Henri Becquerel
Rouen, Normandy, France
Nantes University Hospital
Nantes, Pays de la Loire Region, France
Centre Hospitalier Metropole Savoie
Chambéry, Savoie, France
Centre Hospitalier d'Avignon
Avignon, France
Centre Hospitalier Universitaire (CHU) Montpellier
Montpellier, France
Hopital Saint Louis
Paris, France
Assistance Publique-Hopitaux de Paris (AP-HP)
Paris, France
Institut Curie
Saint-Cloud, France
Hopital Victor Dupouy Argenteuil
Argenteuil, Île-de-France Region, France
Avicenne Hospital
Bobigny, Île-de-France Region, France
Gustave Roussy
Villejuif, Île-de-France Region, France
Stauferklinikum
Mutlangen, Baden-Wurttemberg, Germany
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg, Germany
LMU Klinikum
Munich, Bavaria, Germany
TUM Fakultat fur Medizin - Klinikum Rechts der Isar
Munich, Bavaria, Germany
Clinic Frankfurt (Oder)
Frankfurt am Main, Hesse, Germany
University Hospital Essen
Essen, North Rhine-Westphalia, Germany
Universitatsmedizin der Johannes-Gutenberg Universitat Mainz
Mainz, Rhineland-Palatinate, Germany
University Hospital Halle Saale
Halle, Germany
Stadtisches Krankenhaus Kiel
Kiel, Germany
MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
Neuss, Germany
Assuta Ashdod Medical Center
Ashdod, Israel
Hadassah Medical Center
Jerusalem, Israel
Galilee Medical Center
Nahariya, Israel
Rabin Medical Center
Petah Tikva, Israel
Chaim Sheba Medical Center
Ramat Gan, Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Assuta Medical Centers
Tel Aviv, Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Forli-Cesena, Italy
Ospedale Policlinico San Martino IRCCS
Genoa, Genova, Italy
S Gerardo Hospital
Monza, Monza E Brianza, Italy
A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont, Italy
Centro Di Riferimento Oncologico (CRO), Aviano, National Cancer Institute
Aviano, Pordenone, Italy
Candiolo Cancer Institute, FPO, IRCCS
Candiolo, Torino, Italy
University of Bologna Dipartimento di Medicina Specialistica Diagnostica e Sperimentale
Bologna, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy
ASST Grande Ospedale Metropolitano Niguarda - Main Address
Milan, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Istituto Europeo di Oncologia
Milan, Italy
A.O.U. di Modena
Modena, Italy
Federico II University
Naples, Italy
AOU Maggiore della Carita
Novara, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Azienda Ospedaliera di Perugia
Perugia, Italy
Ospedale Santa Maria delle Croci
Ravenna, Italy
Santa Maria della Misericordia
Udine, Italy
Hospital Sultanah Aminah Jhor Bahru
Johor Bahru, Johor, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, Negeri / Wilayah Persekutuan, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, Sabah, Malaysia
Hospital Ampang
Ampang, Selangor, Malaysia
Subang Jaya Medical Center
Subang Jaya, Selangor, Malaysia
In-Vivo Sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu
Wałbrzych, Lower Silesian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny
Wroclaw, Lower Silesian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie, Centrum Innowacyjnych Terapii
Lublin, Lublin Voivodeship, Poland
Pratia MCM Krakow
Krakow, Malopolska, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Pratia Poznan Medical Center
Poznan, Wielkopolska, Poland