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

NCT07634471 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: 1045-007U1111-1324-30192025-522777-10-00MK-1045-007
• Study Type: interventional
• Target: 960
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (5)

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

  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

  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)

  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

  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)

  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

Secondary Outcomes (15)

• Part 1: Objective Response Rate (ORR)

  Up to approximately 60 months

• Part 1: Duration of CR

  Up to approximately 60 months

• Part 1: Area Under the Concentration-Time Curve at Steady State (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

  Predose and at designated time points post-dose (up to approximately 12 months)

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

  Predose and at designated time points post-dose (up to approximately 12 months)

Study Arms (3)

Part 1: MK-1045 plus Rituximab (or biosimilar)

EXPERIMENTAL

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)

EXPERIMENTAL

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)

EXPERIMENTAL

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

Interventions

MK-1045 BIOLOGICAL

Intravenous (IV) infusion

Also known as: CN201

Part 1: MK-1045 plus Rituximab (or biosimilar); Part 2: MK-1045 plus Rituximab (or biosimilar)

Rituximab BIOLOGICAL

IV infusion

Part 1: MK-1045 plus Rituximab (or biosimilar); Part 2: MK-1045 plus Rituximab (or biosimilar); Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)

Rituximab biosimilar BIOLOGICAL

IV infusion

Also known as: TRUXIMA®, RUXIENCE®, RIABNI®

Part 1: MK-1045 plus Rituximab (or biosimilar); Part 2: MK-1045 plus Rituximab (or biosimilar); Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)

Bendamustine DRUG

IV infusion

Also known as: Bendeka, Treanda, Belrapzo

Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)

Cyclophosphamide DRUG

IV infusion

Also known as: Cytoxan, Neosar, Cytophosphane

Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)

Vincristine DRUG

IV infusion

Also known as: Oncovin, Vincasar PFS

Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)

Prednisone DRUG

Per approved product label

Also known as: Prednisone acetate

Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)

Prednisolone DRUG

Per approved product label

Also known as: Prednisolone acetate

Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)

Doxorubicin Hydrochloride DRUG

IV infusion

Also known as: Adriamycin

Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Rituximab; Bendamustine Hydrochloride; Cyclophosphamide; Vincristine; Prednisone; Prednisolone; prednisolone acetate; Doxorubicin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): July 6, 2026
• Primary Completion (Estimated): July 23, 2032
• Study Completion (Estimated): July 23, 2035
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share