Recruiting
Phase 2
Phase 3

MK-1045 & Rituximab

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07634471

Conditions

Follicular Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MK-1045

Rituximab

Rituximab biosimilar

Bendamustine

Cyclophosphamide

Study Details

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

Study ID

NCT07634471

Start date

Jun 22, 2026

Status verified date

Sep, 2026

Completion date

Jul 23, 2035

Anticipated

Primary completion date

Jul 23, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

960 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: 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.

Interventions

MK-1045

Intravenous (IV) infusion

Rituximab

IV infusion

Rituximab biosimilar

IV infusion

Bendamustine

IV infusion

Cyclophosphamide

IV infusion

Vincristine

IV infusion

Prednisone

Per approved product label

Prednisolone

Per approved product label

Doxorubicin Hydrochloride

IV infusion

Primary outcome measure

  • Part 1: Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 15 months ]
  • 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 ]
  • Part 1: Complete Response (CR) Rate [ Time Frame: Up to approximately 60 months ]
  • Part 2: Progression-Free Survival (PFS) [ Time Frame: Up to approximately 63 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

City of Hope - Duarte Cancer Center ( Site 1301)

Recruiting

Duarte, California, United States, 91010

Contacts

Study Coordinator

877-589-4352

University of Kentucky ( Site 1303)

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Study Coordinator

859-323-2354

Duke Cancer Center Clinic 1B/C Onc/Heme ( Site 1307)

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Study Coordinator

919-681-5698

SCRI Oncology Partners ( Site 7000)

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Study Coordinator

615-329-7640

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-03.