RecruitingNCT07634471ClinicalTrials.gov record

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

Follicular Lymphoma

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 2 / Phase 3
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 960 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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)

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Single masked

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.

Biological: MK-1045 · Biological: Rituximab · Biological: Rituximab biosimilar

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.

Biological: MK-1045 · Biological: Rituximab · Biological: Rituximab biosimilar

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.

Biological: Rituximab · Biological: Rituximab biosimilar · Drug: Bendamustine · Drug: Cyclophosphamide · Drug: Vincristine · Drug: Prednisone · Drug: Prednisolone · Drug: Doxorubicin Hydrochloride

MK-1045 BIOLOGICAL

Intravenous (IV) infusion

Rituximab BIOLOGICAL

IV infusion

Rituximab biosimilar BIOLOGICAL

IV infusion

Bendamustine DRUG

IV infusion

Cyclophosphamide DRUG

IV infusion

Vincristine DRUG

IV infusion

Prednisone DRUG

Per approved product label

Prednisolone DRUG

Per approved product label

Doxorubicin Hydrochloride DRUG

IV infusion

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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.

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

Time frame: Up to approximately 12 months

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.

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.

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 measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Part 2: Number of Participants Who Experience an AE

Time frame: Up to approximately 15 months

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

Time frame: 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)

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.

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

Time frame: 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)

Time frame: Baseline and up to approximately month 13

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (38)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

Find a location in this study

38 locations

City of Hope - Duarte Cancer Center ( Site 1301)Duarte, California, United StatesRecruiting

Study CoordinatorCONTACT877-589-4352

What this study involves

About the research

Who may be able to participate?

Treatment, groups and participation

What researchers are measuring

Primary measures

Secondary measures

Research locations (38)

Study team and timeline

Official study contacts

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