ReclutandoNCT07519772Registro de ClinicalTrials.gov

A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)

Lymphoma, Non-Hodgkin · Lymphoma, Follicular · Lymphoma, Large B-Cell, Diffuse

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LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio: De intervención
Fase: Fase 1 / Fase 2
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 280 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

Researchers are looking for new ways to treat 2 types of non-Hodgkin lymphoma (NHL) called follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). FL is a slow-growing type of NHL. DLBCL is a fast-growing type of NHL. NHL is a cancer in the lymphatic system that causes swollen lymph nodes. The lymphatic system is part of the immune system.

In this study, researchers want to learn if MK-1045 can treat FL and DLBCL. MK-1045 is a study treatment that is an immunotherapy, which helps the immune system fight cancer.

The goals of this study are to learn how safe MK-1045 is and if people tolerate it. Researchers also want to see if FL and DLBCL respond (the cancer gets smaller or goes away) to treatment.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Has disease that has relapsed (disease progression after remission) or is refractory (failure to achieve complete or partial response) to at least 2 prior systemic lines of therapy.
Has a histologically confirmed diagnosis of follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL).
DLBCL participants only: has progressed after or is ineligible for transplant and chimeric antigen receptor T (cell) (CAR-T) therapy.
Has provided tumor tissue sample (archival or newly obtained, if performed per standard of care).
Has documented retained expression of cluster of differentiation 19 (CD19) in tumor tissue obtained by biopsy after disease progression on CD19-targeting therapy, if experienced disease progression after prior CD19-targeting therapy.
Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if has a history of HIV infection.
Has undetectable hepatitis B virus (HBV) viral load and received and will continue to receive HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.
Has undetectable hepatitis C virus (HCV) viral load and received HCV antiviral therapy if has a history of HCV infection.
Has radiographically measurable disease per Lugano Response Criteria.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Has received a solid organ transplant.
Had or has clinically relevant central nervous system (CNS) diseases.
Has a history of serious cardiovascular or cerebrovascular diseases.
Had prior allogenic stem cell transplantation with acute graft-versus-host-disease (GVHD); has ongoing evidence of chronic GVHD manifesting as skin involvement, diarrhea, or increased serum bilirubin; or requires systemic immunosuppression for GVHD.
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 of randomization.
Has received prior CAR-T therapy within 3 months before the first dose of the study intervention.
Has a known additional malignancy that is progressing or required active treatment within the past 2 years.
Has known active CNS lymphoma or involvement.
Has active autoimmune disease that required systemic treatment in the past 2 years.
Has active infection requiring systemic therapy.
Has a history of severe bleeding disorders.
Has not recovered from major surgery or has ongoing surgical complications.
Has diagnosis of primary mediastinal B-cell lymphoma.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Sin enmascaramiento

Arm 1: Follicular Lymphoma (FL) MK-1045 Monotherapy Dose Optimization

Participants will receive Dosage A of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation.

Biological: MK-1045

Arm 2: FL MK-1045 Longer Dosing Interval

Participants will receive Dosage B of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation.

Biological: MK-1045

Arm 3: FL MK-1045 Subcutaneous Administration

Participants will receive Dosage C of MK-1045 by subcutaneous (SC) injection for up to approximately 1 year of treatment or until discontinuation.

Biological: MK-1045

Arm 4: Diffuse Large B-cell Lymphoma (DLBCL) MK-1045 Monotherapy Dose Optimization

Participants will receive Dosage D of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation.

Biological: MK-1045

MK-1045 BIOLOGICAL

Intravenous (IV) Infusion or Subcutaneous (SC) injection

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Number of Participants Who Experience an Adverse Event (AE)

Plazo: Up to approximately 49 months

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

Number of Participants Who Discontinue Study Treatment Due to an AE

Plazo: Up to approximately 12 months

Arms 2 and 3: Number of Participants Who Experience Dose Limiting Toxicity (DLT)

Plazo: Up to approximately 28 days

DLT will be defined as any drug-related AE observed during the DLT evaluation period (up to 28 days) that results in a change to a given dose or a delay in initiating the next treatment.

Arms 1, 2, and 4: Objective Response Rate (ORR) per Lugano Response Criteria as assessed by Blinded Independent Central review (BICR)

Plazo: Up to approximately 49 months

ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and will be evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. Response will be assessed based on the International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). In Arms 1, 2, and 4, the percentage of participants who experience CR or PR as assessed by BICR will be presented.

Medidas secundarias

Arms 1, 2, and 4: Duration of Response (DOR) per Lugano Response Criteria as assessed by BICR

Plazo: Up to approximately 49 months

For participants who demonstrate a confirmed complete response (CR) or partial response (PR), DOR is defined as the time from CR or PR to documented disease progression or death. Participants are assessed using computed tomography (CT) and positron emission tomography (PET)-CT and response will be evaluated based on the Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters (SPD) for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). DOR as assessed by BICR will be presented for Arms 1, 2, and 4.

Arm 3: DOR per Lugano Response Criteria as assessed by Investigator

Plazo: Up to approximately 49 months

Area Under the Concentration-time Curve Measured at Steady State (AUCss) of MK-1045

Plazo: Pre-dose and at designated time points post-dose up to 12 months

Blood samples will be collected to determine the AUCss of MK-1045 in plasma.

Trough Concentration (Ctrough) of MK-1045

Plazo: Pre-dose and at designated time points post-dose up to 12 months

Blood samples will be collected to determine the Ctrough of MK-1045 in plasma.

Maximum Serum Concentration (Cmax) of MK-1045

Plazo: Pre-dose and at designated time points post-dose up to 12 months

Blood samples will be collected to determine the Cmax of MK-1045 in plasma.

Arms 1, 2, and 4: Time to Maximum Serum Concentration (Tmax) of MK-1045

Plazo: Pre-dose and at designated time points post-dose up to 12 months

Blood samples will be collected to determine the Tmax of MK-1045 in plasma.

Arm 3: Absolute Bioavailability Expressed as a Percentage (F%) of MK-1045

Plazo: Pre-dose and at designated time points post-dose up to 12 months

Blood samples will be collected to determine the F% of MK-1045 in plasma.

Arm 3: ORR per Lugano Response Criteria as assessed by Investigator

Plazo: Up to approximately 49 months

ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and will be evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. Response will be assessed based on the International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). In Arm 3, the percentage of participants who experience CR or PR as assessed by the Investigator will be presented.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (54)

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Buscar un centro en este estudio

54 centros

Cedar Sinai Cancer Center ( Site 0119)Los Angeles, California, United StatesReclutando

Study CoordinatorCONTACT310-423-3277

De qué trata este estudio

Acerca de la investigación

¿Quién podría participar?

Tratamiento, grupos y participación

Qué evalúan los investigadores

Medidas principales

Medidas secundarias

Centros de investigación (54)

Equipo y fechas

Contactos oficiales del estudio

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