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Follicular LymphomaCancerBiologicalDrugPhase 2, Phase 3

What this study is

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)

What's being tested

  • MK-1045

    Intervention · BIOLOGICAL

    Intravenous (IV) infusion

  • Rituximab

    Intervention · BIOLOGICAL

  • Rituximab biosimilar

    Intervention · BIOLOGICAL

  • Bendamustine

    Intervention · DRUG

  • Cyclophosphamide

    Intervention · DRUG

  • Vincristine

    Intervention · DRUG

  • Prednisone

    Intervention · DRUG

  • Prednisolone

    Intervention · DRUG

  • Doxorubicin Hydrochloride

    Intervention · DRUG

All of Rituximab, Rituximab biosimilar, Bendamustine, Cyclophosphamide, Vincristine, Doxorubicin Hydrochloride

IV infusion

Both Prednisone and Prednisolone

Per approved product label

Study details

Official title
A Phase 2/3 Randomized, Open-label Study of MK-1045 in Combination With Rituximab in Participants With 1L Follicular Lymphoma
Sponsor
Merck Sharp & Dohme LLC
Conditions
Follicular Lymphoma
Enrolling
960 people
Starts
2026-06-22
Est. completion
2035-07-23
Design
Single-blind, randomized, parallel groups, Phase 2, Phase 3
Record
View on ClinicalTrials.gov ↗