RecruitingPhase 2Phase 3NCT07634471

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

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

Enrollment

960 participants

Start Date

Jun 22, 2026

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bendamustine, a drug called Cyclophosphamide, and others for people with follicular lymphoma. The study is currently recruiting participants at 10 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALMK-1045

Intravenous (IV) infusion

BIOLOGICALRituximab

IV infusion

BIOLOGICALRituximab biosimilar

IV infusion

DRUGBendamustine

IV infusion

DRUGCyclophosphamide

IV infusion

DRUGVincristine

IV infusion

DRUGPrednisone

Per approved product label

DRUGPrednisolone

Per approved product label

DRUGDoxorubicin Hydrochloride

IV infusion


Locations(10)

SCRI Oncology Partners ( Site 7000)

Nashville, Tennessee, United States

Hadassah Medical Center ( Site 0701)

Jerusalem, Israel

Sheba Medical Center ( Site 0702)

Ramat Gan, Israel

Sourasky Medical Center ( Site 0704)

Tel Aviv, Israel

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

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)

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07634471


Related Trials