drugset / Trial / NCT07634471

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

NCT07634471

Phase 2/3 Recruiting 960 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupSingle-blindTreatment

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)

Timeline

Start
2026-06-22
Primary completion
2032-07-23
Completion
2035-07-23

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-1045 Other / unclassified 2 mg Intravenous
Subject MK-1045 Other / unclassified 90 mg Intravenous
Background Bendamustine Small molecule 90 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Background Prednisolone Other / unclassified 40 mg
Background Prednisolone Other / unclassified 100 mg/m2
Background Prednisone Other / unclassified 40 mg
Background Prednisone Other / unclassified 100 mg/m2
Background Riabni Unknown 375 mg/m2 Intravenous
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Vincristine Small molecule 1.4 mg/m2 Intravenous

Indications