A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
4 июня 2026 г. обновлено: Merck Sharp & Dohme LLC
A Phase 2/3 Randomized, Open-label Study of MK-1045 in Combination With Rituximab in Participants With 1L Follicular Lymphoma
Researchers are looking for new ways to treat follicular lymphoma (FL). A standard (usual) treatment for FL includes a targeted therapy called rituximab and chemotherapy. In this study, researchers want to learn if giving a study medicine called MK-1045 and rituximab can treat FL. MK-1045 is a type of treatment called immunotherapy.
The goals of this study are to learn:
- About the safety of MK-1045 and rituximab, and if people tolerate them when given together
- If people who receive MK-1045 and rituximab have the cancer go away
- If people who receive MK-1045 and rituximab live longer without their cancer getting worse compared to those who receive standard treatment (rituximab and chemotherapy)
Обзор исследования
Статус
Еще не набирают
Условия
Тип исследования
Интервенционный
Регистрация (Оцененный)
960
Фаза
- Фаза 2
- Фаза 3
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- Has biopsy-proven, previously untreated, histologically confirmed cluster of differentiation (CD)19-positive and CD20-positive classical follicular lymphoma (FL), with Ann Arbor Stage II-IV disease and a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5.
- Has radiographically measurable disease per the Lugano Response Criteria.
- Has provided a newly obtained core or excisional biopsy or archival tissue of a tumor lesion not previously irradiated.
- If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy (ART).
- If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it.
- If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.
Exclusion Criteria:
- Has received prior systemic anticancer therapy or radiotherapy for FL.
- Has follicular large B-cell lymphoma or any other subtype of FL other than classical FL.
- Has FL that has transformed into a more aggressive type of lymphoma.
- History or presence of clinically relevant central nervous system (CNS) diseases.
- Has history of serious cardiovascular and cerebrovascular diseases.
- Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has known active CNS lymphoma or involvement.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- Has active infection requiring systemic therapy.
- Has chronic liver disease, including liver cirrhosis of Child-Pugh class B or C.
- Has not adequately recovered from major surgery or has ongoing surgical complications.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Part 1: MK-1045 plus Rituximab (or biosimilar)
Participants will receive escalating doses of MK-1045 (from 2 mg to 90 mg) once weekly (QW) for up to approximately 12 months.
Participants will also receive 375 mg/m^2 rituximab (or biosimilar) once every 4 weeks (Q4W) for up to approximately 6 months.
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Внутривенное вливание
Intravenous (IV) infusion
Другие имена:
IV infusion
Другие имена:
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Экспериментальный: Part 2: MK-1045 plus Rituximab (or biosimilar)
Participants will receive MK-1045 QW at the dose determined in Part 1 for up to approximately 12 months.
Participants will also receive 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months.
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Внутривенное вливание
Intravenous (IV) infusion
Другие имена:
IV infusion
Другие имена:
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Экспериментальный: Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)
Participants will receive physician's choice of: 90 mg/m^2 bendamustine on Days 1 and 2 of each 4-week cycle for up to 6 cycles (up to approximately 6 months) plus 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months OR 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 1.4 mg/m^2 vincristine on day 1 of each 3-week cycle (Q3W) and 100 mg/m^2 prednisone (or prednisolone) once daily on days 1 through 5 Q3W for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 4 months OR 750 mg/m^2 cyclophosphamide and 1.4 mg/m^2 vincristine Q3W and 40 mg/day prednisone (or prednisolone) once daily on days 1 through 5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 6 months.
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Внутривенное вливание
Внутривенное вливание
Другие имена:
Внутривенная инфузия
Другие имена:
Внутривенная инфузия
Другие имена:
IV infusion
Другие имена:
Per approved product label
Другие имена:
Per approved product label
Другие имена:
IV infusion
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Part 1: Number of Participants Who Experience an Adverse Event (AE)
Временное ограничение: Up to approximately 15 months
|
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
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Up to approximately 15 months
|
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Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
Временное ограничение: Up to approximately 12 months
|
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
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Up to approximately 12 months
|
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Part 1: Number of Participants Who Experience Dose Limiting Toxicity (DLT)
Временное ограничение: Up to approximately 36 days
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DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle.
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Up to approximately 36 days
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Part 1: Complete Response (CR) Rate
Временное ограничение: Up to approximately 60 months
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For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) per Lugano response criteria.
CR rate is defined as the percentage of participants who experience a CR.
The CR rate as assessed by physician investigator will be presented.
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Up to approximately 60 months
|
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Part 2: Progression-Free Survival (PFS)
Временное ограничение: Up to approximately 63 months
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PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first.
|
Up to approximately 63 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Part 1: Objective Response Rate (ORR)
Временное ограничение: Up to approximately 60 months
|
ORR is defined as the percentage of participants with CR (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Lugano response criteria.
The percentage of participants who experience CR or PR as assessed by physician investigator will be presented.
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Up to approximately 60 months
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Part 1: Duration of CR
Временное ограничение: Up to approximately 60 months
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For participants who demonstrate CR (CR: disappearance of all target lesions) at end of treatment per Lugano response criteria, defined as the time from the first documented evidence of CR until disease progression or death due to any cause, whichever occurs first.
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Up to approximately 60 months
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Part 1: Area Under the Concentration-Time Curve at Steady State (AUCss) of MK-1045
Временное ограничение: Predose and at designated time points post-dose (up to approximately 12 months)
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Blood samples will be collected at multiple time points to estimate the AUCss of MK-1045.
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Predose and at designated time points post-dose (up to approximately 12 months)
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Part 1: Maximum Concentration (Cmax) of MK-1045
Временное ограничение: Predose and at designated time points post-dose (up to approximately 12 months)
|
Blood samples will be collected at multiple time points to estimate the Cmax of MK-1045.
|
Predose and at designated time points post-dose (up to approximately 12 months)
|
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Part 1: Trough Concentration (Ctrough) of MK-1045
Временное ограничение: Predose and at designated time points post-dose (up to approximately 12 months)
|
Blood samples will be collected at multiple time points to estimate the Ctrough of MK-1045.
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Predose and at designated time points post-dose (up to approximately 12 months)
|
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Part 2: CR Rate at 30 Months
Временное ограничение: 30 months
|
For participants who demonstrate a confirmed CR (CR: disappearance of all target lesions) per Lugano response criteria.
CR rate is defined as the percentage of participants who experience a CR by month 30.
The CR rate as assessed by BICR at month 30 will be presented.
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30 months
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Part 2: ORR
Временное ограничение: Up to approximately 63 months
|
ORR is defined as the percentage of participants with CR (CR: disappearance of all target lesions) or PR (PR: at least a 30% decrease in the sum of diameters of target lesions) per Lugano response criteria.
The percentage of participants who experience CR or PR as assessed by BICR will be presented.
|
Up to approximately 63 months
|
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Part 2: Overall Survival (OS)
Временное ограничение: Up to approximately 63 months
|
OS is defined as the time from randomization to death due to any cause.
|
Up to approximately 63 months
|
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Part 2: Event-Free Survival (EFS)
Временное ограничение: Up to approximately 63 months
|
EFS is defined as the time randomization to the first documented disease progression per Lugano response criteria by BICR, death due to any cause, initiation of a new anticancer therapy or a positive biopsy for residual disease, whichever occurs first.
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Up to approximately 63 months
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Part 2: Duration of CR
Временное ограничение: Up to approximately 63 months
|
For participants who demonstrate CR (CR: disappearance of all target lesions) per Lugano response criteria by BICR, defined as the time from the first documented evidence of CR until disease progression or death due to any cause, whichever occurs first.
|
Up to approximately 63 months
|
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Part 2: Number of Participants Who Experience an AE
Временное ограничение: Up to approximately 15 months
|
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
|
Up to approximately 15 months
|
|
Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE
Временное ограничение: Up to approximately 12 months
|
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
|
Up to approximately 12 months
|
|
Part 2: Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Trial Outcome Index (TOI)
Временное ограничение: Baseline and up to approximately month 13
|
The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients.
Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S).
The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108.
FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116.
FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168.
The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much.
The higher the score the better the quality of life.
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Baseline and up to approximately month 13
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Part 2: Change From Baseline in HRQoL on FACT-Lym Total Score
Временное ограничение: Baseline and up to approximately month 13
|
The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients.
Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S).
The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108.
FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116.
FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168.
The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much.
The higher the score the better the quality of life.
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Baseline and up to approximately month 13
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Part 2: Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB) (Items General Physical [GP]1 Through GP7)
Временное ограничение: Baseline and up to approximately month 13
|
The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients.
Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S).
The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108.
FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116.
FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168.
The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much.
The higher the score the better the quality of life.
|
Baseline and up to approximately month 13
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Директор по исследованиям: Medical Director, Merck Sharp & Dohme LLC
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Полезные ссылки
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
6 июля 2026 г.
Первичное завершение (Оцененный)
23 июля 2032 г.
Завершение исследования (Оцененный)
23 июля 2035 г.
Даты регистрации исследования
Первый отправленный
4 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
4 июня 2026 г.
Первый опубликованный (Действительный)
8 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
8 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
4 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Новообразования
- Заболевания иммунной системы
- Новообразования по гистологическому типу
- Лимфатические заболевания
- Лимфопролиферативные заболевания
- Иммунопролиферативные заболевания
- Лимфома, неходжкинская
- Лимфома
- Гемики и лимфатические заболевания
- Лимфома, фолликулярная
- Аминокислоты, пептиды и белки
- Белки
- Органические химические вещества
- Гетероциклические соединения
- Бензимидазолы
- Гетероциклические соединения, 2-кольцо
- Гетероциклические соединения, слитое кольцо
- Углеводороды
- Углеводороды, циклические
- Углеводы
- Кислоты, ациклические
- Карбоновые кислоты
- Алкалоиды
- Полициклические ароматические углеводороды
- Углеводороды, ароматные
- Полициклические соединения
- Гликозиды
- Индолы
- Антитела, моноклональные
- Антитела
- Иммуноглобулины
- Иммунопротеины
- Белки крови
- Сывороточные глобулины
- Глобулины
- Беременные
- Беременные
- Стероиды
- Соединения слитого кольца
- Фосфорамид горчицы
- Азотные соединения горчицы
- Горчичные соединения
- Углеводороды, галогенированные
- Фосфорамиды
- Соединения органофосфора
- Bergyadienetriols
- Беременные
- VINCA ALKALOIDS
- Секологические триптаминовые алкалоиды
- Индольные алкалоиды
- Индолизидины
- Индолизины
- Антрациклины
- Нафтацены
- Аминогликозиды
- Бутират
- Антитела, моноклональные, происходящие из мыши
- Даунорубицин
- Бендамустин гидрохлорид
- Ритуксимаб
- Преднизолон
- Преднизолон
- Циклофосфамид
- Доксорубицин
- Винкристин
- ацетат преднизолона
Другие идентификационные номера исследования
- 1045-007
- U1111-1324-3019 (Идентификатор реестра: UTN)
- 2025-522777-10-00 (Идентификатор реестра: EU CT)
- MK-1045-007 (Другой идентификатор: MSD)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Да
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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