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RECRUITING
NCT07634471
PHASE2/PHASE3

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

MK-1045

Intravenous (IV) infusion

BIOLOGICAL

Rituximab

IV infusion

BIOLOGICAL

Rituximab biosimilar

IV infusion

DRUG

Bendamustine

IV infusion

DRUG

Cyclophosphamide

IV infusion

DRUG

Vincristine

IV infusion

DRUG

Prednisone

Per approved product label

DRUG

Prednisolone

Per approved product label

DRUG

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)