Clinical trial NCT06091254: A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma
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 Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Follicular Lymphoma (FL)
Keywords: Non-Hodgkin lymphomas (NHLs)
Indolent NHL
B-cells NHL (B-NHL)
Follicular lymphoma
Odronextamab
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-10-19
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 (a type of non-Hodgkin lymphoma or NHL).

This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled).

The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone.

The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") 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)
* How the study drug affects quality of life and ability to complete routine daily activities.


Eligibility criteria: Key Inclusion Criteria:

1. Diagnosis of Cluster of Differentiation 20\^+ (CD20\^+) FL Grade 1-3a, stage II bulky or stage III / IV
2. Need for treatment as described in the protocol
3. Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
5. Adequate bone marrow function and hepatic function

Key Exclusion Criteria:

1. Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma
2. Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
3. Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
4. Treatment with any systemic anti-lymphoma therapy
5. Infections and allergy/hypersensitivity to study drug or excipient

NOTE: Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Incidence of dose-limiting toxicities (DLTs) for odronextamab
timeFrame: Up to 35 days
measure: Incidence of treatment-emergent adverse events (TEAEs) of odronextamab
timeFrame: Up to 2 years
measure: Severity of TEAEs of odronextamab
timeFrame: Up to 2 years
measure: Complete Response at 30 months (CR30) as assessed by independent central review
timeFrame: Up to 30 months
Secondary outcomes:
measure: Concentrations of odronextamab in serum
timeFrame: Up to 30 months
measure: Incidence of anti-drug antibodies (ADAs) to odronextamab over the study duration
timeFrame: Up to 30 months
measure: Titer of ADAs to odronextamab over the study duration
timeFrame: Up to 30 months
measure: Incidence of neutralizing antibodies (NAbs) to odronextamab over the study duration
timeFrame: Up to 30 months
measure: Objective response as assessed by the investigator
timeFrame: Up to 30 months
measure: Progression-free survival (PFS) as assessed by independent central review
timeFrame: Up to 5 years
measure: Event-free survival (EFS) as assessed by independent central review
timeFrame: Up to 5 years
measure: CR30 as assessed by local investigator
timeFrame: Up to 30 months
measure: Overall mean change in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)]
timeFrame: Up to 5 years
measure: Overall survival (OS)
timeFrame: Up to 5 years
measure: PFS as assessed by the local investigator
timeFrame: Up to 5 years
measure: EFS as assessed by the local investigator
timeFrame: Up to 5 years
measure: Objective response assessed by local investigator
timeFrame: Up to 30 months
measure: Objective response assessed by independent central review
timeFrame: Up to 30 months
measure: Duration of response (DOR) assessed by independent central review
timeFrame: Up to 5 years
measure: DOR assessed by local investigator
timeFrame: Up to 5 years
measure: Time to next anti-lymphoma treatment (TTNT)
timeFrame: Up to 5 years
measure: Incidence of TEAEs
timeFrame: Up to 2 years
measure: Severity of TEAEs
timeFrame: Up to 2 years
measure: Odronextamab concentrations in serum during the induction period
timeFrame: Up to 30 months
measure: Odronextamab concentrations in serum during the maintenance period
timeFrame: Up to 30 months
measure: Incidence of ADAs to odronextamab over the study duration
timeFrame: Up to 30 months
measure: Titer of ADAs to odronextamab over the study duration
timeFrame: Up to 30 months
measure: Incidence of NAbs to odronextamab over the study duration
timeFrame: Up to 30 months
measure: Overall mean changes in scores of patient reported outcomes (PROs), as measured by the validated instruments EORTCQLQ- C30
timeFrame: Up to 5 years
measure: Overall mean changes in scores of PROs, as measured by the validated instruments Functional Assessment of Cancer Therapy-Lymphoma (FACT-LymS)
timeFrame: Up to 5 years
measure: Overall mean changes in scores of PROs, as measured by the validated instruments Patient Global Impression of Severity (PGIS)
timeFrame: Up to 5 years
measure: Overall mean changes in scores of PROs, as measured by the validated instruments Patient Global Impression of Change (PGIC)
timeFrame: Up to 5 years
measure: Overall mean changes in scores of PROs, as measured by the validated instruments EuroQol-5 Dimension-5 Level Scale (EQ-5D- 5L)
timeFrame: Up to 5 years
measure: Overall mean changes in scores PROs, as measured by the validated Functional Assessment of Cancer - General (FACT-G) global population 5 (GP5) question
timeFrame: Up to 5 years
measure: Change in score of the GP5 item in the participant population
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
city: Orange
country: United States
facility: UC Irvine Health
state: California
city: Noblesville
country: United States
facility: Investigative Clinical Research of Indiana
state: Indiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: New York
country: United States
facility: Icahn School of Medicine at Mt Sinai
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Westbury
country: United States
facility: Clinical Research Alliance Inc
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Center for Oncology and Blood Disorders
state: Texas
city: Tyler
country: United States
facility: HOPE Cancer Center of East Texas
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute - Oncology Division
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Waukesha
country: United States
facility: Prohealth Care Inc
state: Wisconsin
city: Liverpool
country: Australia
facility: Ingham Institute
state: New South Wales
city: Auchenflower
country: Australia
facility: Icon Cancer Centre - Wesley
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: East Melbourne
country: Australia
facility: Epworth Freemasons
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital - Melbourne
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital and Monash University
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz
state: Osterreich
city: Linz
country: Austria
facility: Ordensklinikum Linz Gmbh, Elisabethinen
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Vienna
country: Austria
facility: Hanusch Krankenhaus
city: Herentals
country: Belgium
facility: AZ St.-Elisabeth Herentals vzw
state: Antwerp
city: Haine-Saint-Paul
country: Belgium
facility: Hopital De Jolimont
state: Hainaut
city: Gent
country: Belgium
facility: Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
state: Oost-Vlaanderen
city: Antwerp
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen Stuivenberg
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Salvador
country: Brazil
facility: Ensino e Terapia de Inovacao Clinica Amo (Etica)
state: Bahia
city: Belo Horizonte
country: Brazil
facility: Instituto Mario Pena de Ensino Pesquisa e Inovacao
state: Minas Gerais
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Cancer
state: Rio Grande Do Norte
city: Passo Fundo
country: Brazil
facility: Instituto do Cancer em Hospital Sao Vicente de Paulo
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Joinville
country: Brazil
facility: Centro de Hematologia e Oncologia
state: Santa Catarina
city: Lages
country: Brazil
facility: Animi Unidade de Tratamento Oncologico Ltda
state: Santa Catarina
city: Barretos
country: Brazil
facility: Fundacao Pio XII Hospital de Amor
state: Sao Paulo
city: Jau
country: Brazil
facility: Amaral Carvalho Hospital
state: Sao Paulo
city: Ribeirao Preto
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
state: Sao Paulo
city: Brasilia
country: Brazil
facility: Instituto DOr de Pesquisa e Ensino Df Star
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer Jose Alencar Gomes da Silva
city: Rio de Janeiro
country: Brazil
facility: Instituto Americas
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
city: Sao Paulo
country: Brazil
facility: AC Camargo Cancer Center
city: Sao Paulo
country: Brazil
facility: Clinical Hospital of Medicine School at Sao Paulo University
city: Sao Paulo
country: Brazil
facility: Casa de Saude Santa Marcelina
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: Greenfield Park
country: Canada
facility: Cisss de la Monteregie-Centre
state: Quebec
city: Quebec City
country: Canada
facility: CHU de Quebec - Universite Laval
state: Quebec
city: Sherbrooke
country: Canada
facility: Ciusss de Lestrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)
state: Quebec
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez
state: Region Metropolitana
city: Santiago
country: Chile
facility: Inmunocel
state: Region Metropolitana
city: Santiago
country: Chile
facility: Clinica Alemana de Santiago
state: Region Metropolitana
city: Santiago
country: Chile
facility: Centro Oncologia de Precision Universidad Mayor
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
city: Prague
country: Czechia
facility: University Hospital Kralovske Vinohrady
city: Praha
country: Czechia
facility: Vseobecna Fakultni Nemocnice
city: Rennes
country: France
facility: Centre Hospitalier Universitaire (CHU) Rennes
state: Bretagne
city: Tours
country: France
facility: Centre Hospitalier Regional Universitaire de Tours
state: Centre Val De Loire
city: Argenteuil
country: France
facility: Hopital Victor Dupouy Argenteuil
state: Ile De France
city: Villejuif
country: France
facility: Gustave Roussy
state: Ile De France
city: Nantes
country: France
facility: Nantes University Hospital
state: Pays De La Loire
city: Marseille
country: France
facility: Hopital de la Conception
state: Provence-Alpes-Cote d'Azur
city: Angers
country: France
facility: Centre Hospitalier Universitaire Angers
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital Saint-Antoine
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire (CHU) de Poitiers
city: Strasbourg
country: France
facility: Institut de Cancerologie Strasbourg Europe (ICANS)
city: Würzburg
country: Germany
facility: University Hospital Wurzburg
state: Bavaria
city: Mutlangen
country: Germany
facility: Kliniken Ostalb Stauferklinikum Schwab Gmund
state: Gmund
city: Frankfurt
country: Germany
facility: Clinic Frankfurt (Oder)
state: Hesse
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes-Gutenberg Universitat Mainz
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: Hematological Praxis Dresden
state: Sachsen
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin Campus Benjamin Franklin
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus
city: Kiel
country: Germany
facility: Stadtisches Krankenhaus Kiel
city: Ashdod
country: Israel
facility: Samson Assuta Ashdod University Hospital
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Meldola
country: Italy
facility: Istituto Romagnolo Per Lo Studio Dei Tumori
state: Forli Cesena
city: Bologna
country: Italy
facility: Irccs Aou Di Bologna- Policlinico Di Sant'Orsola Malpighi
state: Italia
city: Tricase
country: Italy
facility: Pia Fondazione Panico
state: Lecce
city: Genoa
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
state: Liguria
city: Candiolo
country: Italy
facility: Candiolo Cancer Institute, FPO, IRCCS
state: Torino
city: Ascoli Piceno
country: Italy
facility: UOC Ematologia e Terapia Cellulare - PO Mazzoni AST Ascoli Piceno
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Napoli
country: Italy
facility: Federico II University
city: Novara
country: Italy
facility: AOU Maggiore della Carita-SCDU Ematologia
city: Ravenna
country: Italy
facility: UO Ematologia Ravenna
city: Udine
country: Italy
facility: Santa Maria della Misericordia
city: Varese
country: Italy
facility: Ospedale dell'Angelo - Varese
city: Goyang
country: Korea, Republic of
facility: Center for Hematologic Malignancy
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: St. Vincents Hospital - The Catholic University of Korea
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny
state: Dolnoslaskie
city: Walbrzych
country: Poland
facility: Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu
state: Lower Silesian
city: Krakow
country: Poland
facility: Pratia MCM Krakow
state: Malopolska
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
state: Pomorskie
city: Poznan
country: Poland
facility: Cm Pratia Poznan
state: Wielkopolska
city: Skorzewo
country: Poland
facility: Aidport
state: Wielkopolska
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice
city: Lodz
country: Poland
facility: Copernicus Memorial Hospital
city: Lublin
country: Poland
facility: Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa
city: Santiago de Compostela
country: Spain
facility: University Hospital of Santiago de Compostela
state: A Coruna
city: Malaga
country: Spain
facility: Hospital Universitario Virgen De La Victoria Malaga
state: Andalucia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
state: Andalucia
city: Oviedo
country: Spain
facility: Hospital Universitario Central De Asturias
state: Asturias
city: Palma
country: Spain
facility: Son Espases University Hospital
state: Balearic Islands
city: Barakaldo
country: Spain
facility: Cruces University Hospital (Hospital Universitario Cruces)
state: Bizkaia
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario de a Coruna
state: Galicia
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quironsalud Madrid
state: Madrid
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Granada
country: Spain
facility: Hospital Virgen De Las Nieves De Granada
city: Madrid
country: Spain
facility: Gregorio Maranon
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz University Hospital
city: Madrid
country: Spain
facility: University Hospital & Research Institute
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro, Servicio de Hematologia
city: Murcia
country: Spain
facility: Morales Meseguer Hospital
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Seville
country: Spain
facility: University Hospital Virgen del Rocio
city: Toledo
country: Spain
facility: Hospital General Universitario de Toledo
city: Valencia
country: Spain
facility: Hospital Clinico Universitario Valencia
city: Valencia
country: Spain
facility: Hospital Universitari and Politecnic La Fe
city: Zaragoza
country: Spain
facility: Hospital Clinico Lozano Blesa
city: Baden
country: Switzerland
facility: Kantonsspital Baden
state: Aargau
city: St Gallen
country: Switzerland
facility: Cantonal Hospital St Gallen
state: Saint Gallen
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur Medical Oncology
state: Schweiz
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: Inselspital Bern University Hospital
city: Puzi City
country: Taiwan
facility: Chang Gung Medical Foundation Chia Yi Branch
state: Chiayi County
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital Linkou
state: Guishan District
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: Taichung General Veterans Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Municipal Wan Fang Hospital
city: Yenimahalle
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
state: Ankara
city: Ankara
country: Turkey
facility: Gazi University
state: Central Anatolia
city: Mezitli
country: Turkey
facility: VM Medical Park Mersin Hospital
state: Mersin
city: Tekirdag
country: Turkey
facility: Tekirdag Namik Kemal University Hospital
state: Suleymanpasa
city: Ankara
country: Turkey
facility: Liv Hospital Ankara
city: Istanbul
country: Turkey
facility: VKV American Hopital
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine
city: Izmir
country: Turkey
facility: Ege University
city: Kayseri
country: Turkey
facility: Erci̇yes Uni̇versi̇ty
city: Sakarya
country: Turkey
facility: Sakarya Universty Medical Faculty
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
city: Zonguldak
country: Turkey
facility: Zonguldak Bulent Ecevit University
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital NHS Trust
state: Cornwall
city: Plymouth
country: United Kingdom
facility: Derriford Hospital and the Royal Eye Infirmary
state: Devon
city: Bournemouth
country: United Kingdom
facility: University Hospitals Dorset
state: Dorset
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
state: Lanarkshire
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: Norfolk
city: Romford
country: United Kingdom
facility: Barking, Havering and Redbridge University Hospitals NHS Trust
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: