A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
4 de junio de 2026 actualizado por: 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)
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
960
Fase
- Fase 2
- Fase 3
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Infusión intravenosa
Intravenous (IV) infusion
Otros nombres:
IV infusion
Otros nombres:
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Experimental: 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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Infusión intravenosa
Intravenous (IV) infusion
Otros nombres:
IV infusion
Otros nombres:
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Experimental: 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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Infusión intravenosa
Infusión intravenosa
Otros nombres:
Infusión intravenosa
Otros nombres:
Infusión intravenosa
Otros nombres:
IV infusion
Otros nombres:
Per approved product label
Otros nombres:
Per approved product label
Otros nombres:
IV infusion
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Part 1: Number of Participants Who Experience an Adverse Event (AE)
Periodo de tiempo: 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
Periodo de tiempo: Up to approximately 12 months
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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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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Up to approximately 63 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Part 1: Objective Response Rate (ORR)
Periodo de tiempo: Up to approximately 60 months
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 Cmax 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: Trough Concentration (Ctrough) of MK-1045
Periodo de tiempo: 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 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
Periodo de tiempo: 30 months
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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
Periodo de tiempo: 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.
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Up to approximately 63 months
|
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Part 2: Overall Survival (OS)
Periodo de tiempo: Up to approximately 63 months
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OS is defined as the time from randomization to death due to any cause.
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Up to approximately 63 months
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Part 2: Event-Free Survival (EFS)
Periodo de tiempo: Up to approximately 63 months
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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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)
Periodo de tiempo: Baseline and up to approximately month 13
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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
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Medical Director, Merck Sharp & Dohme LLC
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
6 de julio de 2026
Finalización primaria (Estimado)
23 de julio de 2032
Finalización del estudio (Estimado)
23 de julio de 2035
Fechas de registro del estudio
Enviado por primera vez
4 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de junio de 2026
Publicado por primera vez (Actual)
8 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Enfermedades linfáticas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Linfoma No Hodgkin
- Linfoma
- Enfermedades hemic y linfáticas
- Linfoma Folicular
- Aminoácidos, péptidos y proteínas
- Proteínas
- Químicos orgánicos
- Compuestos heterocíclicos
- Benzimidazoles
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Hidrocarburos
- Hidrocarburos, cíclico
- Carbohidratos
- Ácidos, acíclico
- Ácidos carboxílicos
- Alcaloides
- Hidrocarburos aromáticos policíclicos
- Hidrocarburos, aromáticos
- Compuestos policíclicos
- Glucósidos
- Indoles
- Anticuerpos, monoclonal
- Anticuerpos
- Inmunoglobulinas
- Inmunoproteínas
- Proteínas de la sangre
- Globulinas séricas
- Globulinas
- Espierra
- Embarazos
- Esteroides
- Compuestos de anillo fusionado
- Mostaza de fosforamida
- Compuestos de mostaza de nitrógeno
- Compuestos de mostaza
- Hidrocarburos, halogenados
- Fosforamidas
- Compuestos organofosforados
- Esparrazadienetrioles
- Madreadiediols
- Alcaloides de Vinca
- Alcaloides de triptamina de secologanina
- Alcaloides de indol
- Indolizidinas
- Indolizinas
- Antraciclinas
- Naftacenos
- Aminoglucósidos
- Butiratos
- Anticuerpos, monoclonales, derivados de murino
- Daunorrubicina
- Clorhidrato de bendamustina
- Rituximab
- Prednisona
- Prednisolona
- Ciclofosfamida
- Doxorrubicina
- Vincristina
- acetato de prednisolona
Otros números de identificación del estudio
- 1045-007
- U1111-1324-3019 (Identificador de registro: UTN)
- 2025-522777-10-00 (Identificador de registro: EU CT)
- MK-1045-007 (Otro identificador: MSD)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Rituximab
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Children's Oncology GroupNational Cancer Institute (NCI)TerminadoTrastorno linfoproliferativo posterior al trasplante relacionado con el VEB | Trastorno linfoproliferativo postrasplante monomórfico | Trastorno linfoproliferativo polimórfico postrasplante | Trastorno linfoproliferativo monomórfico recurrente posrasplante | Trastorno linfoproliferativo polimórfico... y otras condicionesEstados Unidos
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)TerminadoLinfoma folicular de grado 1 recidivante | Linfoma folicular de grado 2 recidivante | Linfoma de células del manto recidivante | Linfoma recidivante de la zona marginal | Linfoma no Hodgkin de células B refractario | Linfoma de linfocitos pequeños recidivante | Linfoma no Hodgkin de células B recurrente y otras condicionesEstados Unidos
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National Cancer Institute (NCI)TerminadoLinfoma folicular de grado 1 en estadio III de Ann Arbor | Linfoma folicular de grado 2 en estadio III de Ann Arbor | Linfoma folicular de grado 1 en estadio IV de Ann Arbor | Linfoma folicular de grado 2 en estadio IV de Ann Arbor | Linfoma folicular contiguo grado 3 en estadio II de Ann... y otras condicionesEstados Unidos
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Activo, no reclutandoLinfoma de linfocitos pequeños recidivante | Leucemia prolinfocítica | Leucemia linfocítica crónica recurrenteEstados Unidos
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Activo, no reclutandoLeucemia linfocítica crónica/linfoma linfocítico de células pequeñasEstados Unidos
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Mabion SAParexelRetirado
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Activo, no reclutandoLinfoma folicular de grado 1 en estadio I de Ann Arbor | Linfoma folicular de grado 2 en estadio I de Ann Arbor | Linfoma folicular de grado 1 en estadio II de Ann Arbor | Linfoma folicular de grado 2 en estadio II de Ann ArborEstados Unidos
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The First Affiliated Hospital with Nanjing Medical...Aún no reclutandoDLBCL - Linfoma difuso de células B grandes
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National Cancer Institute (NCI)Celgene CorporationActivo, no reclutandoLinfoma folicular de grado 1 en estadio III de Ann Arbor | Linfoma folicular de grado 2 en estadio III de Ann Arbor | Linfoma folicular de grado 1 en estadio IV de Ann Arbor | Linfoma folicular de grado 2 en estadio IV de Ann Arbor | Linfoma folicular contiguo grado 3 en estadio II de Ann... y otras condicionesEstados Unidos
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Mayo ClinicNational Cancer Institute (NCI)TerminadoLinfoma folicular de grado 1 en estadio I de Ann Arbor | Linfoma folicular de grado 2 en estadio I de Ann Arbor | Linfoma folicular de grado 1 en estadio III de Ann Arbor | Linfoma folicular de grado 2 en estadio III de Ann Arbor | Linfoma folicular de grado 1 en estadio IV de Ann Arbor | Linfoma... y otras condicionesEstados Unidos