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NCT Number: NCT07634471

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

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)

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Key information

Conditions

Follicular Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hadassah Medical Center ( Site 0701), Jerusalem, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MK-1045

Biological

Intravenous (IV) infusion

Other names: CN201

Rituximab

Biological

IV infusion

Rituximab Biosimilar

Biological

IV infusion

Other names: TRUXIMA®, RUXIENCE®, RIABNI®

Bendamustine

Drug

IV infusion

Other names: Bendeka, Treanda, Belrapzo

Cyclophosphamide

Drug

IV infusion

Other names: Cytoxan, Neosar, Cytophosphane

Vincristine

Drug

IV infusion

Other names: Oncovin, Vincasar PFS

Prednisone

Drug

Per approved product label

Other names: Prednisone acetate

Prednisolone

Drug

Per approved product label

Other names: Prednisolone acetate

Doxorubicin hydrochloride

Drug

IV infusion

Other names: Adriamycin

Primary outcomes

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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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.

Secondary outcomes

  1. Part 1: Objective Response Rate (ORR)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 2/3 Randomized, Open-label Study of MK-1045 in Combination With Rituximab in Participants With 1L Follicular Lymphoma

Important dates

Study start
2026
Primary completion
2032
Study completion
2035
First posted
Jun 8, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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