A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
torstai 4. kesäkuuta 2026 päivittänyt: 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)
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Ehdot
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
960
Vaihe
- Vaihe 2
- Vaihe 3
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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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IV-infuusio
Intravenous (IV) infusion
Muut nimet:
IV infusion
Muut nimet:
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Kokeellinen: 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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IV-infuusio
Intravenous (IV) infusion
Muut nimet:
IV infusion
Muut nimet:
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Kokeellinen: 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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IV-infuusio
IV-infuusio
Muut nimet:
IV-infuusio
Muut nimet:
IV infuusio
Muut nimet:
IV infusion
Muut nimet:
Per approved product label
Muut nimet:
Per approved product label
Muut nimet:
IV infusion
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Part 1: Number of Participants Who Experience an Adverse Event (AE)
Aikaikkuna: Up to approximately 15 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 15 months
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Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Part 1: Objective Response Rate (ORR)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Opintojohtaja: Medical Director, Merck Sharp & Dohme LLC
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
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Perjantai 23. heinäkuuta 2032
Opintojen valmistuminen (Arvioitu)
Maanantai 23. heinäkuuta 2035
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 4. kesäkuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 4. kesäkuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Maanantai 8. kesäkuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Maanantai 8. kesäkuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 4. kesäkuuta 2026
Viimeksi vahvistettu
Maanantai 1. kesäkuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Neoplasmat
- Immuunijärjestelmän sairaudet
- Neoplasmat histologisen tyypin mukaan
- Lymfaattiset sairaudet
- Lymfoproliferatiiviset häiriöt
- Immunoproliferatiiviset häiriöt
- Lymfooma, non-Hodgkin
- Lymfooma
- Hemic- ja imusuutteet
- Lymfooma, follikulaarinen
- Aminohapot, peptidit ja proteiinit
- Proteiinit
- Orgaaniset kemikaalit
- Heterosykliset yhdisteet
- Bentsimidatsolit
- Heterosykliset yhdisteet, 2-rengas
- Heterosykliset yhdisteet, sulatettu rengas
- Hiilivety
- Hiilivedyt, sykliset
- Hiilihydraatit
- Hapot, asyklinen
- Karboksyylihapot
- Alkaloidit
- Poltisykliset aromaattiset hiilivedyt
- Hiilivedyt, aromaattiset
- Polisykliset yhdisteet
- Glykosidit
- Indolit
- Vasta -aineet, monoklonaalinen
- Vasta -aineet
- Immunoglobuliinit
- Immunoproteiinit
- Veriproteiinit
- Seerumin globuliinit
- Globuliinit
- Raskaat
- Raskaat
- Steroidit
- Sulatettu rengasyhdisteet
- Fosforamidi -sinapit
- Typpisinappiyhdisteet
- Sinappiyhdisteet
- Hiilivety, halogenoitu
- Fosforamidit
- Organofosforiyhdisteet
- Raskaat
- Raskaat
- Vinca -alkaloidit
- Secologaniinin tryptamiini -alkaloidit
- Indolialkaloidit
- Indolitsidiinit
- Indolisoija
- Antrasykliinit
- Nafthaceenit
- Aminoglykosidit
- Butyraatit
- Vasta-aineet, monoklonaalinen, hiiren johdettu
- Daunorubisiini
- Bendamustiinihydrokloridi
- Rituksimabi
- Prednisoni
- Prednisoloni
- Syklofosfamidi
- Doksorubisiini
- Vincristine
- prednisoloniasetaatti
Muut tutkimustunnusnumerot
- 1045-007
- U1111-1324-3019 (Rekisterin tunniste: UTN)
- 2025-522777-10-00 (Rekisterin tunniste: EU CT)
- MK-1045-007 (Muu tunniste: MSD)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Ascentage Pharma Group Inc.Ei vielä rekrytointiaRelapsoituneet/refraktoriset hematologiset pahanlaatuiset kasvaimet | Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL | Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL; Including Richter Transformation) | Relapsi- tai refraktori-mantelisolulymfooma... ja muut ehdotKiina, Yhdysvallat
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University of WashingtonNational Cancer Institute (NCI)LopetettuToistuva marginaalialueen lymfooma | Waldenströmin makroglobulinemia | Marginaalialueen lymfooma | Refractory marginaalivyöhykkeen lymfooma | Toistuva Waldenströmin makroglobulinemia | Tulenkestävä Waldenströmin makroglobulinemiaYhdysvallat
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M.D. Anderson Cancer CenterAktiivinen, ei rekrytointiVaippasolulymfoomaYhdysvallat
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University of WashingtonMillennium Pharmaceuticals, Inc.Aktiivinen, ei rekrytointiFollikulaarinen lymfooma | Waldenströmin makroglobulinemia | Vaippasolulymfooma | Marginaalialueen lymfooma | Krooninen lymfosyyttinen leukemia | Lymfoplasmasyyttinen lymfooma | Pieni lymfosyyttinen lymfooma | Limakalvoon liittyvän imusolmukkeen toistuva ekstranodaalisen marginaalialueen lymfooma | Refractory...Yhdysvallat
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiivinen, ei rekrytointiToistuva pieni lymfosyyttinen lymfooma | Prolymfosyyttinen leukemia | Toistuva krooninen lymfosyyttinen leukemiaYhdysvallat
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)LopetettuToistuva 1. asteen follikulaarinen lymfooma | Toistuva asteen 2 follikulaarinen lymfooma | Toistuva vaippasolulymfooma | Toistuva marginaalialueen lymfooma | Tulenkestävä B-soluinen non-Hodgkin-lymfooma | Toistuva pieni lymfosyyttinen lymfooma | Toistuva B-solujen non-Hodgkin-lymfooma | Toistuva asteen... ja muut ehdotYhdysvallat
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Mayo ClinicNational Cancer Institute (NCI)LopetettuAnn Arborin vaiheen I asteen 1 follikulaarinen lymfooma | Ann Arborin vaiheen I asteen 2 follikulaarinen lymfooma | Ann Arborin vaiheen III asteen 1 follikulaarinen lymfooma | Ann Arborin vaiheen III asteen 2 follikulaarinen lymfooma | Ann Arborin vaiheen IV luokan 1 follikulaarinen lymfooma | Ann... ja muut ehdotYhdysvallat
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)ValmisAnn Arborin vaiheen III asteen 1 follikulaarinen lymfooma | Ann Arborin vaiheen III asteen 2 follikulaarinen lymfooma | Ann Arbor Stage III Indolent Adult Non-Hodgkin Lymfooma | Ann Arborin vaiheen IV luokan 1 follikulaarinen lymfooma | Ann Arborin vaiheen IV asteen 2 follikulaarinen lymfooma | Ann... ja muut ehdotYhdysvallat
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Nantes University HospitalValmisLymfooma, suurisoluinen, diffuusiRanska