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A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
Sponsor: Merck Sharp & Dohme LLC
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)
Official title: A Phase 2/3 Randomized, Open-label Study of MK-1045 in Combination With Rituximab in Participants With 1L Follicular Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
960
Start Date
2026-06-22
Completion Date
2035-07-23
Last Updated
2026-08-14
Healthy Volunteers
No
Conditions
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
Locations (17)
Duke Cancer Center Clinic 1B/C Onc/Heme ( Site 1307)
Durham, North Carolina, United States
SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee, United States
Instituto Alexander Fleming ( Site 0105)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Sanatorio Nuestra Senora del Rosario ( Site 0104)
Rosario, Santa Fe Province, Argentina
Hadassah Medical Center ( Site 0701)
Jerusalem, Israel
Sheba Medical Center ( Site 0702)
Ramat Gan, Israel
Sourasky Medical Center ( Site 0704)
Tel Aviv, Israel
Institut Català d'Oncologia (ICO) - Badalona ( Site 0904)
Badalona, Barcelona, Spain
Hospital Virgen de la Victoria ( Site 0905)
Málaga, Malaga, Spain
Hospital Universitari Vall de Hebron ( Site 0903)
Barcelona, Spain
Hospital Universitario Gregorio Maranon ( Site 0902)
Madrid, Spain
Hospital Universitario de Salamanca ( Site 0906)
Salamanca, Spain
National Taiwan University Hospital ( Site 1001)
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 1002)
Taoyuan, Taiwan
Hacettepe Universite Hastaneleri ( Site 1110)
Ankara, Turkey (Türkiye)
Sisli Florence Nightingale Hastanesi ( Site 1112)
Istanbul, Turkey (Türkiye)
Ondokuz Mayıs Universitesi ( Site 1113)
Samsun, Turkey (Türkiye)