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Purpose

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)

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Biological: MK-1045
    Intravenous (IV) infusion
    Other names:
    • CN201
  • Biological: Rituximab
    IV infusion
  • Biological: Rituximab biosimilar
    IV infusion
    Other names:
    • TRUXIMA®
    • RUXIENCE®
    • RIABNI®
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.
  • Biological: MK-1045
    Intravenous (IV) infusion
    Other names:
    • CN201
  • Biological: Rituximab
    IV infusion
  • Biological: Rituximab biosimilar
    IV infusion
    Other names:
    • TRUXIMA®
    • RUXIENCE®
    • RIABNI®
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.
  • Biological: Rituximab
    IV infusion
  • Biological: Rituximab biosimilar
    IV infusion
    Other names:
    • TRUXIMA®
    • RUXIENCE®
    • RIABNI®
  • Drug: Bendamustine
    IV infusion
    Other names:
    • Bendeka
    • Treanda
    • Belrapzo
  • Drug: Cyclophosphamide
    IV infusion
    Other names:
    • Cytoxan
    • Neosar
    • Cytophosphane
  • Drug: Vincristine
    IV infusion
    Other names:
    • Oncovin
    • Vincasar PFS
  • Drug: Prednisone
    Per approved product label
    Other names:
    • Prednisone acetate
  • Drug: Prednisolone
    Per approved product label
    Other names:
    • Prednisolone acetate
  • Drug: Doxorubicin Hydrochloride
    IV infusion
    Other names:
    • Adriamycin

Recruiting Locations

SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee 37203
Contact:
Study Coordinator
844-482-4812

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.