A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
4. juni 2026 oppdatert av: 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)
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
960
Fase
- Fase 2
- Fase 3
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
IV infusjon
Intravenous (IV) infusion
Andre navn:
IV infusion
Andre navn:
|
|
Eksperimentell: 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.
|
IV infusjon
Intravenous (IV) infusion
Andre navn:
IV infusion
Andre navn:
|
|
Eksperimentell: 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.
|
IV infusjon
IV infusjon
Andre navn:
IV infusjon
Andre navn:
IV infusjon
Andre navn:
IV infusion
Andre navn:
Per approved product label
Andre navn:
Per approved product label
Andre navn:
IV infusion
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Part 1: Number of Participants Who Experience an Adverse Event (AE)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Part 1: Objective Response Rate (ORR)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
6. juli 2026
Primær fullføring (Antatt)
23. juli 2032
Studiet fullført (Antatt)
23. juli 2035
Datoer for studieregistrering
Først innsendt
4. juni 2026
Først innsendt som oppfylte QC-kriteriene
4. juni 2026
Først lagt ut (Faktiske)
8. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Lymfesykdommer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom
- Hemic og lymfatiske sykdommer
- Lymfom, follikulær
- Aminosyrer, peptider og proteiner
- Proteiner
- Organiske kjemikalier
- Heterocykliske forbindelser
- Benzimidazoles
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Hydrokarboner
- Hydrokarboner, syklisk
- Karbohydrater
- Syrer, acyklisk
- Karboksylsyrer
- Alkaloider
- Polysykliske aromatiske hydrokarboner
- Hydrokarboner, aromatisk
- Polysykliske forbindelser
- Glykosider
- Indoler
- Antistoffer, monoklonalt
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Gravadienes
- Gravaner
- Steroider
- Smeltede ringforbindelser
- Fosforamid -sennep
- Nitrogen sennepsforbindelser
- Sennepsforbindelser
- Hydrokarboner, halogenert
- Fosforamider
- Organofosforforbindelser
- Gravadienetrioler
- Gravadienedioler
- Vinca -alkaloider
- Secologanin tryptaminalkaloider
- Indolalkaloider
- Indolizidiner
- Indolisiner
- Antracykliner
- Naphthacenes
- Aminoglykosider
- Butyrates
- Antistoffer, monoklonale, murine-avledede
- Daunorubicin
- Bendamustinhydroklorid
- Rituximab
- Prednison
- Prednisolon
- Cyklofosfamid
- Doxorubicin
- Vincristine
- prednisolonacetat
Andre studie-ID-numre
- 1045-007
- U1111-1324-3019 (Registeridentifikator: UTN)
- 2025-522777-10-00 (Registeridentifikator: EU CT)
- MK-1045-007 (Annen identifikator: MSD)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Rituximab
-
Children's Oncology GroupNational Cancer Institute (NCI)FullførtEBV-relatert post-transplantasjon lymfoproliferativ lidelse | Monomorf post-transplantasjon lymfoproliferativ lidelse | Polymorf post-transplantasjon lymfoproliferativ lidelse | Tilbakevendende monomorf post-transplantasjon lymfoproliferativ lidelse | Tilbakevendende polymorf post-transplantasjon... og andre forholdForente stater
-
National Cancer Institute (NCI)FullførtAnn Arbor stadium III grad 1 follikulært lymfom | Ann Arbor stadium III grad 2 follikulært lymfom | Ann Arbor Stage IV Grad 1 Follikulært lymfom | Ann Arbor Stage IV Grad 2 Follikulært lymfom | Ann Arbor trinn II grad 3 kontinuerlig follikulær lymfom | Ann Arbor Stage II grad 3 ikke-sammenhengende... og andre forholdForente stater
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeTilbakevendende lite lymfatisk lymfom | Prolymfocytisk leukemi | Tilbakevendende kronisk lymfatisk leukemiForente stater
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)AvsluttetTilbakevendende grad 1 follikulært lymfom | Tilbakevendende grad 2 follikulært lymfom | Tilbakevendende mantelcellelymfom | Tilbakevendende marginalsone lymfom | Refraktær B-celle non-Hodgkin lymfom | Tilbakevendende lite lymfatisk lymfom | Tilbakevendende B-celle non-Hodgkin lymfom | Tilbakevendende... og andre forholdForente stater
-
The First Affiliated Hospital with Nanjing Medical...Har ikke rekruttert ennåDLBCL - Diffust storcellet B-celle lymfom
-
Mabion SAParexelTilbaketrukket
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeAnn Arbor stadium I grad 1 follikulært lymfom | Ann Arbor stadium I grad 2 follikulært lymfom | Ann Arbor stadium II grad 1 follikulært lymfom | Ann Arbor stadium II grad 2 follikulært lymfomForente stater
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeKronisk lymfatisk leukemi/liten lymfatisk lymfomForente stater
-
M.D. Anderson Cancer CenterAktiv, ikke rekrutterendeMantelcellelymfomForente stater
-
Beijing InnoCare Pharma Tech Co., Ltd.Rekruttering