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A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)

4 de junho de 2026 atualizado 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)

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

960

Estágio

  • Fase 2
  • Fase 3

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Biológico: Rituximabe
Infusão IV
Biológico: MK-1045
Intravenous (IV) infusion
Outros nomes:
  • CN201
Biológico: Rituximab biosimilar
IV infusion
Outros nomes:
  • TRUXIMA®
  • RUXIENCE®
  • RIABNI®
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.
Biológico: Rituximabe
Infusão IV
Biológico: MK-1045
Intravenous (IV) infusion
Outros nomes:
  • CN201
Biológico: Rituximab biosimilar
IV infusion
Outros nomes:
  • TRUXIMA®
  • RUXIENCE®
  • RIABNI®
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.
Biológico: Rituximabe
Infusão IV
Medicamento: Ciclofosfamida
Infusão IV
Outros nomes:
  • Cytoxan
  • Citofosfano
  • Neosar
Medicamento: Bendamustina
Infusão intravenosa
Outros nomes:
  • Treanda
  • Bendeka
  • Belrapzo
Medicamento: Vincristina
Infusão intravenosa
Outros nomes:
  • Oncovin
  • Vincasar PFS
Biológico: Rituximab biosimilar
IV infusion
Outros nomes:
  • TRUXIMA®
  • RUXIENCE®
  • RIABNI®
Medicamento: Prednisone
Per approved product label
Outros nomes:
  • Acetato de prednisona
Medicamento: Prednisolone
Per approved product label
Outros nomes:
  • Acetato de prednisolona
Medicamento: Doxorubicin Hydrochloride
IV infusion
Outros nomes:
  • Adriamicina

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Part 1: Number of Participants Who Experience an Adverse Event (AE)
Prazo: 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 1: Number of Participants Who Discontinue Study Treatment Due to an AE
Prazo: 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 1: Number of Participants Who Experience Dose Limiting Toxicity (DLT)
Prazo: Up to approximately 36 days
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.
Up to approximately 36 days
Part 1: Complete Response (CR) Rate
Prazo: Up to approximately 60 months
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.
Up to approximately 60 months
Part 2: Progression-Free Survival (PFS)
Prazo: Up to approximately 63 months
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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Part 1: Objective Response Rate (ORR)
Prazo: 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.
Up to approximately 60 months
Part 1: Duration of CR
Prazo: Up to approximately 60 months
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.
Up to approximately 60 months
Part 1: Area Under the Concentration-Time Curve at Steady State (AUCss) of MK-1045
Prazo: 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 AUCss of MK-1045.
Predose and at designated time points post-dose (up to approximately 12 months)
Part 1: Maximum Concentration (Cmax) of MK-1045
Prazo: 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)
Part 1: Trough Concentration (Ctrough) of MK-1045
Prazo: 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.
Predose and at designated time points post-dose (up to approximately 12 months)
Part 2: CR Rate at 30 Months
Prazo: 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.
30 months
Part 2: ORR
Prazo: 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
Part 2: Overall Survival (OS)
Prazo: Up to approximately 63 months
OS is defined as the time from randomization to death due to any cause.
Up to approximately 63 months
Part 2: Event-Free Survival (EFS)
Prazo: 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.
Up to approximately 63 months
Part 2: Duration of CR
Prazo: 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
Part 2: Number of Participants Who Experience an AE
Prazo: 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
Prazo: 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)
Prazo: 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
Part 2: Change From Baseline in HRQoL on FACT-Lym Total Score
Prazo: 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
Part 2: Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB) (Items General Physical [GP]1 Through GP7)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Merck Sharp & Dohme LLC

Investigadores

  • Diretor de estudo: Medical Director, Merck Sharp & Dohme LLC

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

6 de julho de 2026

Conclusão Primária (Estimado)

23 de julho de 2032

Conclusão do estudo (Estimado)

23 de julho de 2035

Datas de inscrição no estudo

Enviado pela primeira vez

4 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de junho de 2026

Primeira postagem (Real)

8 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 1045-007
  • U1111-1324-3019 (Identificador de registro: UTN)
  • 2025-522777-10-00 (Identificador de registro: EU CT)
  • MK-1045-007 (Outro identificador: MSD)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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