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 Adult Participants With Previously Untreated Follicular Lymphoma

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат Odronextamab
  Administered per the protocol
• Препарат Rituximab
  Administered per the protocol
• Препарат Cyclophosphamide
  Administered per the protocol as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy
• Препарат Doxorubicin
  Administered per the protocol as part of CHOP chemotherapy
• Препарат Vincristine
  Administered per the protocol as part of CHOP, and CVP chemotherapy
• Препарат Prednisone/prednisolone
  Administered per the protocol as part of CVP chemotherapy
• Препарат Bendamustine
  Administered per the protocol as part of chemotherapy (Rituximab-Bendamustine)

Первичные конечные точки

• Incidence of Dose-Limiting Toxicities (DLTs) for odronextamab [Срок оценки: Up to 35 days]
• Incidence of Treatment-Emergent Adverse Events (TEAEs) of odronextamab [Срок оценки: Up to 2 years]
• Severity of TEAEs of odronextamab [Срок оценки: Up to 2 years]
• Complete Response at 30 months (CR30) as assessed by independent central review [Срок оценки: Up to 30 months]

Вторичные конечные точки (12)

• Concentrations of odronextamab in serum [Срок оценки: Up to 30 months]
• Occurrence of Anti-Drug Antibodies (ADAs) to odronextamab [Срок оценки: Up to 30 months]
• Magnitude of ADAs to odronextamab [Срок оценки: Up to 30 months]
• Objective response as assessed by the investigator [Срок оценки: Up to 30 months]
• Progression-Free Survival (PFS) as assessed by independent central review [Срок оценки: Up to 5 years]
• Event-Free Survival (EFS) as assessed by independent central review [Срок оценки: Up to 5 years]
• Overall Survival (OS) [Срок оценки: Up to 5 years]
• Overall mean change in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)] [Срок оценки: Up to 5 years]
• CR30 as assessed by local investigator [Срок оценки: Up to 30 months]
• PFS as assessed by the local investigator [Срок оценки: Up to 5 years]
• EFS as assessed by the local investigator [Срок оценки: Up to 5 years]
• Objective response assessed by local investigator [Срок оценки: Up to 30 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

NOTE: Other protocol defined inclusion/exclusion criteria apply

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 29 центров

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США · 20 центров

• University of Arizona Cancer Center — Tucson
• David Geffen School of Medicine at UCLA — Los Angeles
• UC Irvine Health — Orange
• Investigative Clinical Research of Indiana — Noblesville
• Beth Israel Deaconess Medical Center — Boston
• Karmanos Cancer Institute — Detroit
• Hattiesburg Clinic — Hattiesburg
• Icahn School of Medicine at Mt Sinai — New York
• … и ещё 12 центров

Бразилия · 17 центров

• Ensino e Terapia de Inovacao Clinica Amo (Etica) — Salvador
• Instituto Mario Pena de Ensino Pesquisa e Inovacao — Belo Horizonte
• 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
• Centro de Hematologia e Oncologia — Joinville
• Animi Unidade de Tratamento Oncologico Ltda — Lages
• Fundacao Pio XII Hospital de Amor — Barretos
• … и ещё 9 центров

Италия · 13 центров

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Turkey (Türkiye) · 13 центров

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Франция · 12 центров

• Centre Hospitalier Universitaire (CHU) Rennes — Rennes
• Centre Hospitalier Regional Universitaire de Tours — Tours
• Nantes University Hospital — Nantes
• Hopital de la Conception — Marseille
• Centre Hospitalier Universitaire Angers — Angers
• Institut Paoli Calmettes — Marseille
• Hopital Saint Louis — Paris
• Hopital Saint-Antoine — Paris
• … и ещё 4 центра

Тайвань · 12 центров

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Польша · 10 центров

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Германия · 9 центров

• Robert-Bosch-Krankenhaus — Stuttgart
• University Hospital Wurzburg — Würzburg
• … и ещё 7 центров

South Korea · 8 центров

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Австралия · 7 центров

• Ingham Institute — Liverpool
• Icon Cancer Centre - Wesley — Auchenflower
• Flinders Medical Centre — Bedford Park
• Monash Health — Clayton
• Epworth Freemasons — East Melbourne
• St Vincent's Hospital - Melbourne — Fitzroy
• Alfred Hospital and Monash University — Melbourne

Израиль · 7 центров

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Великобритания · 6 центров

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Австрия · 5 центров

• Ordensklinikum Linz — Linz
• Ordensklinikum Linz Gmbh, Elisabethinen — Linz
• Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III — Salzburg
• Medical University of Vienna — Vienna
• Hanusch Krankenhaus — Vienna

Бельгия · 5 центров

• AZ St.-Elisabeth Herentals vzw — Herentals
• Hopital De Jolimont — La Louvière
• Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital — Ghent
• Ziekenhuis Netwerk Antwerpen Stuivenberg — Antwerp
• Institut Jules Bordet — Brussels

Канада · 5 центров

• Tom Baker Cancer Center — Calgary
• Saint John Regional Hospital — Saint John
• Centre Integre de Sante et de Services Sociaux (CISSS) de la Monteregie-Centre — Greenfield Park
• CHU de Quebec - Universite Laval — Québec
• Ciusss de Lestrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS) — Sherbrooke

Швейцария · 5 центров

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Чили · 4 центра

• Fundacion Arturo Lopez Perez — Santiago
• Centro Oncologia de Precision Universidad Mayor — Santiago
• Inmunocel — Santiago
• Clinica Alemana de Santiago — Santiago

Чехия · 3 центра

• University Hospital Hradec Kralove — Hradec Králové
• University Hospital Kralovske Vinohrady — Prague
• Vseobecna Fakultni Nemocnice — Prague

Идентификаторы

NCT: NCT06091254 · R1979-HM-2298 · 2022-502660-20-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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