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

NCT07634471
clinicaltrials.gov
Phase
Phase 2/Phase 3
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
960
clinicaltrials.gov
Lead sponsor
Merck Sharp & Dohme LLC
clinicaltrials.gov
Start date
2026-06-22
clinicaltrials.gov
Number of sites
21
clinicaltrials.gov

Summary
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)
clinicaltrials.gov
Short title
A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
clinicaltrials.gov
Official title
A Phase 2/3 Randomized, Open-label Study of MK-1045 in Combination With Rituximab in Participants With 1L Follicular Lymphoma
clinicaltrials.gov

Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 2/Phase 3
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2035-07-23
clinicaltrials.gov
First posted
2026-06-08
clinicaltrials.gov
Registry last updated
2026-08-28
clinicaltrials.gov
Primary completion date
2032-07-23
clinicaltrials.gov
Start date
2026-06-22
clinicaltrials.gov

Participants
960
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
960
clinicaltrials.gov
Protocol amendments
0
clinicaltrials.gov
Number of sites
21
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Merck Sharp & Dohme LLC
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07634471
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07634471
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Single masking
Masked roles
Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Part 1: Number of Participants Who Experience an Adverse Event (AE)

    Timeframe: 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.

  2. Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE

    Timeframe: 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.

  3. Part 1: Number of Participants Who Experience Dose Limiting Toxicity (DLT)

    Timeframe: 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.

  4. Part 1: Complete Response (CR) Rate

    Timeframe: 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.

  5. Part 2: Progression-Free Survival (PFS)

    Timeframe: 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.

  1. Part 1: Objective Response Rate (ORR)

    Timeframe: 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.

  2. Part 1: Duration of CR

    Timeframe: 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.

  3. Part 1: Area Under the Concentration-Time Curve at Steady State (AUCss) of MK-1045

    Timeframe: 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.

  4. Part 1: Maximum Concentration (Cmax) of MK-1045

    Timeframe: 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.

  5. Part 1: Trough Concentration (Ctrough) of MK-1045

    Timeframe: 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.

  6. Part 2: CR Rate at 30 Months

    Timeframe: 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.

  7. Part 2: ORR

    Timeframe: 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.

  8. Part 2: Overall Survival (OS)

    Timeframe: Up to approximately 63 months

    OS is defined as the time from randomization to death due to any cause.

  9. Part 2: Event-Free Survival (EFS)

    Timeframe: 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.

  10. Part 2: Duration of CR

    Timeframe: 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.

  11. Part 2: Number of Participants Who Experience an AE

    Timeframe: 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.

  12. Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE

    Timeframe: 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.

  13. 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)

    Timeframe: 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.

  14. Part 2: Change From Baseline in HRQoL on FACT-Lym Total Score

    Timeframe: 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.

  15. Part 2: Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB) (Items General Physical [GP]1 Through GP7)

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Duke Cancer Center Clinic 1B/C Onc/Heme ( Site 1307)Durham, United StatesRecruiting
  • SCRI Oncology Partners ( Site 7000)Nashville, United StatesRecruiting
  • Instituto Alexander Fleming ( Site 0105)Ciudad Autonoma de Buenos Aires, ArgentinaRecruiting
  • Sanatorio Nuestra Senora del Rosario ( Site 0104)Rosario, ArgentinaRecruiting
  • Hospital Privado Universitario de Córdoba ( Site 0102)Córdoba, ArgentinaRecruiting
  • Box Hill Hospital ( Site 0201)Box Hill, AustraliaRecruiting
  • Beijing Cancer hospital ( Site 0501)Beijing, ChinaRecruiting
  • Hadassah Medical Center ( Site 0701)Jerusalem, IsraelRecruiting
  • Sheba Medical Center ( Site 0702)Ramat Gan, IsraelRecruiting
  • Sourasky Medical Center ( Site 0704)Tel Aviv, IsraelRecruiting
  • Samsung Medical Center ( Site 0801)Seoul, South KoreaRecruiting
  • Institut Català d'Oncologia (ICO) - Badalona ( Site 0904)Badalona, SpainRecruiting
  • Hospital Virgen de la Victoria ( Site 0905)Málaga, SpainRecruiting
  • Hospital Universitari Vall de Hebron ( Site 0903)Barcelona, SpainRecruiting
  • Hospital Universitario Gregorio Maranon ( Site 0902)Madrid, SpainRecruiting
  • Hospital Universitario de Salamanca ( Site 0906)Salamanca, SpainRecruiting
  • National Taiwan University Hospital ( Site 1001)Taipei, TaiwanRecruiting
  • Chang Gung Medical Foundation-Linkou Branch ( Site 1002)Taoyuan, TaiwanRecruiting
  • Hacettepe Universite Hastaneleri ( Site 1110)Ankara, Turkey (Türkiye)Recruiting
  • Sisli Florence Nightingale Hastanesi ( Site 1112)Istanbul, Turkey (Türkiye)Recruiting
  • Ondokuz Mayıs Universitesi ( Site 1113)Samsun, Turkey (Türkiye)Recruiting
Sources for sites
clinicaltrials.gov

  • MK-1045-007
  • 2025
  • U1111-1324-3019
  • 2025-522777-10-00
Sources for references
clinicaltrials.gov

Related records

Drugs (7)

Lead sponsors (1)

Conditions (1)

Targets (18)