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)

Status: Active_not_recruiting
Location: See all (142) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

‣ For Part 1A: previously untreated participants who have Follicular Lymphoma International Prognostic Index (FLIPI)-1 score of 3 to 5, or R/R FL

⁃ For Part 1B: previously untreated participants who have FLIPI-1 score of 3 to 5

⁃ For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5

• 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 0-2

• Adequate bone marrow and hepatic function.

Locations
United States
Florida
Boca Raton Clinical Research (BRCR) Global
Plantation
Indiana
Investigative Clinical Research of Indiana
Noblesville
Kentucky
University of Kentucky
Lexington
Michigan
Henry Ford Health System
Detroit
Cancer and Hematology Centers of Western Michigan
Grand Rapids
New York
Clinical Research Alliance Inc
Westbury
Texas
Center for Oncology and Blood Disorders
Houston
Utah
Community Cancer Trials of Utah
Ogden
Wisconsin
Prohealth Care Inc
Waukesha
Other Locations
Australia
Pindara Private Hospital
Benowa
Liverpool Hospital
Liverpool
Calvary Mater Newcastle
Waratah
Austria
Medical University of Graz
Graz
Innsbruck Medical University
Innsbruck
Landeskrankenhaus Hochsteiermark
Leoben
Kepler University Hospital
Linz
Karl Landsteiner University Hospital St. Poelten
Sankt Pölten
Universitatsklinik fur Kinder und Jungendheilkunde
Vienna
Klinikum Wels-Grieskirchen
Wels
Belgium
Algemeen Ziekenhuis St Jan Brugge Oostende Av
Bruges
Institut Jules Bordet
Brussels
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent
AZ Groeninge
Kortrijk
Centre Hospitalier Regional de la Citadelle
Liège
Verenigde Ziekenhuizen van Waas en Durme
Sint-niklaas
Brazil
Fundacao Pio XII Hospital de Amor
Barretos
Instituto Mario Pena de Ensino Pesquisa e Inovacao
Belo Horizonte
Instituto Tacchini de Pesquisa em Saude
Bento Gonçalves
Hospital Sirio Libanes Brasilia
Brasília
Instituto DOr de Pesquisa e Ensino Df Star
Brasília
Hospital Erasto Gaertner
Curitiba
Amaral Carvalho Hospital
Jaú
Centro de Hematologia e Oncologia
Joinville
Animi Unidade de Tratamento Oncologico Ltda
Lages
Liga Norte Riograndense Contra o Cancer
Natal
Instituto do Cancer em Hospital Sao Vicente de Paulo
Passo Fundo
Hospital de Clinicas de Porto Alegre
Porto Alegre
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Ribeirão Preto
Instituto Nacional dCancer Jose Alencar Gomes da Silva
Rio De Janeiro
Ensino e Terapia de Inovacao Clinica Amo (Etica)
Salvador
Hospital Santa Izabel - Santa Casa de Misericordia da Bahia
Salvador
Hospital Sao Rafael
Salvador
AC Camargo Cancer Center
São Paulo
Casa de Saude Santa Marcelina
São Paulo
Clinical Hospital of Medicine School at Sao Paulo University
São Paulo
Hospital Alemao Oswaldo Cruz
São Paulo
Centro Oncologico do Triangulo (COT) - Uberlandia
Uberlândia
Chile
Centro Oncologia de Precision Universidad Mayor
Santiago
Hospital Clinico Universidad de Los Andes
Santiago
Inmunocel
Santiago
Pontificia Universidad Catolica de Chile
Santiago
France
Hopital Victor Dupouy Argenteuil
Argenteuil
Cannes Hospital (Centre Hospitalier Cannes Simone Veil)
Cannes
The Novo Hospital North West Val Deoise
Cergy-pontoise
Centre Hospitalier Universitaire de Grenoble
Grenoble
Centre Hospitalier Emile Roux
Le Puy-en-velay
Centre Hospitalier de Lens (Centre Hospitalier Dr Schaffner dLens)
Lens
Centre Hospitalier de Mont-de-Marsan
Mont-de-marsan
Nantes University Hospital
Nantes
Institut de Cancerologie du Gard
Nîmes
Hopital Saint Louis
Paris
Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Sud - Hôpital Haut Lévêque
Pessac
CHU de Saint-Etienne
Saint-etienne
Centre Hospitalier de Saint Nazaire
Saint-nazaire
CHRU de Tours
Tours
Germany
Stadtisches Krankenhaus Kiel
Kiel
MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
Neuss
Israel
Soroka University Medical Center
Beersheba
Rambam Health Care Campus
Haifa
Hadassah Medical Center
Jerusalem
Shaare Zedek Medical Center
Jerusalem
Rabin Medical Center
Petah Tikva
Assuta Medical Centers
Tel Aviv
The Tel Aviv Sourasky Medical Center
Tel Aviv
Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola
ASST Grande Ospedale Metropolitano Niguarda - Main Address
Milan
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
Istituto Europeo di Oncologia
Milan
A.O.U. di Modena
Modena
Federico II University
Napoli
Azienda Ospedaliera Universitario Policlinico Palermo
Palermo
Azienda Ospedaliera di Perugia
Perugia
University of Pisa, Section of Hematology
Pisa
Azienda Ospedaliera Regionale San Carlo
Potenza
UO Ematologia Ravenna
Ravenna
Azienda Unita Sanitaria Locale Irccs Arcispedale Santa Maria Nuova
Reggio Emilia
Azienda Osperdaliero-Universitaria Policlinico Umberto 1
Rome
Azienda Ospedaliera Ordine Mauriziano Torino, Presidio Umberto I of Turin
Turin
Azienda Sanitaria Universitaria del Friuli Centrale
Udine
Poland
Szpital Uniwersytecki Nr2 Bydgoszcz
Bydgoszcz
Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center
Gdansk
Pratia Onkologia Katowice
Katowice
Matopolskie Centrum Medyczne S.C.
Krakow
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)
Lodz
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin
Aidport
Skorzewo
Szpital Szpecjalistyczny w Walbrzychu
Wałbrzych
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa
Warsaw
Spain
Hospital General Universitario Doctor Balmis Alicante
Alicante
Cruces University Hospital (Hospital Universitario Cruces)
Barakaldo
Hospital Universitario Lucus Augusti
Lugo
Clinica Universidad de Navarra - Madrid
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Fundacion Jimenez Diaz
Madrid
Hospital Universitario Infanta Leonor
Madrid
Hospital Universitario Ramon y Cajal
Madrid
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda
Complexo Hospitalario Universitario de Ourense
Ourense
Hospital Universitario Central de Asturias
Oviedo
Clinica Universidad de Navarra- Pamplona
Pamplona
Hospital Universitario de Navarra
Pamplona
Hospital Universitario Quiron Salud Madrid
Pozuelo De Alarcón
Parc Tauli Sabadell Hospital Universitari
Sabadell
Hospital Universitario de Salamanca
Salamanca
Hospital Universitario Virgen del Rocio
Seville
Hospital Universitario Virgen Macarena
Seville
Hospital Universitari Mutua Terrassa
Terrassa
Hospital Clinico Universitario de Valencia
Valencia
Instituto Valenciano de Oncologia
Valencia
Taiwan
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City
Kaohsiung Medical University Hospital
Kaohsiung City
Taipei Medical University - Shuang Ho Hospital
New Taipei City
Taipei Medical University Multipal Wan Fang University
Taipei
Taipei Veterans General Hospital
Taipei
Tri-Service General Hospital
Taipei
Thailand
Chulalongkorn University
Bangkok
Khon Kaen University
Khon Kaen
Turkey
Gazi University
Ankara
Liv Hospital Ankara
Ankara
Istanbul University
Istanbul
VKV American Hopital
Istanbul
Erci̇yes Uni̇versi̇ty
Kayseri
VM Medical Park Mersin Hospital
Mezitli
Sakarya University
Sakarya
Ondokuz Mayıs University
Samsun
Tekirdag Namik Kemal University Hospital
Tekirdağ
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Yenimahalle
Zonguldak Bulent Ecevit University
Zonguldak
United Kingdom
NHS Grampian: Aberdeen Royal Infirmary
Aberdeen
University Hospitals Birmingham NHS Foundation Trust
Birmingham
Royal Cornwall Hospital
Truro
The Hillingdon Hospitals NHS Foundation Trust
Uxbridge
Time Frame
Start Date: 2023-11-14
Completion Date: 2029-07-29
Participants
Target number of participants: 733
Treatments
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.
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.
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.
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.
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov

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