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NCT07634471PHASE2, PHASE3Recruiting

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

Merck Sharp & Dohme LLC

Start Date

6/22/2026

Completion Date

7/23/2035

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Has biopsy-proven, previously untreated, histologically confirmed cluster of differentiation (CD)19-positive and CD20-positive classical follicular lymphoma (FL), with Ann Arbor Stage II-IV disease and a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5. * Has radiographically measurable disease per the Lugano Response Criteria. * Has provided a newly obtained core or excisional biopsy or archival tissue of a tumor lesion not previously irradiated. * If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy (ART). * If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it. * If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load. Exclusion Criteria: * Has received prior systemic anticancer therapy or radiotherapy for FL. * Has follicular large B-cell lymphoma or any other subtype of FL other than classical FL. * Has FL that has transformed into a more aggressive type of lymphoma. * History or presence of clinically relevant central nervous system (CNS) diseases. * Has history of serious cardiovascular and cerebrovascular diseases. * Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy. * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. * Has known active CNS lymphoma or involvement. * Has an active autoimmune disease that has required systemic treatment in the past 2 years. * Has active infection requiring systemic therapy. * Has chronic liver disease, including liver cirrhosis of Child-Pugh class B or C. * Has not adequately recovered from major surgery or has ongoing surgical complications.

Interventions

BIOLOGICAL

MK-1045

BIOLOGICAL

Rituximab

BIOLOGICAL

Rituximab biosimilar

DRUG

Bendamustine

DRUG

Cyclophosphamide

DRUG

Vincristine

DRUG

Prednisone

DRUG

Prednisolone

DRUG

Doxorubicin Hydrochloride

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Conditions

Follicular Lymphoma

Locations

SCRI Oncology Partners ( Site 7000)

Nashville, Tennessee 37203

United States

Hadassah Medical Center ( Site 0701)

Jerusalem, 9112001

Israel

Sheba Medical Center ( Site 0702)

Ramat Gan, 5265601

Israel

Sourasky Medical Center ( Site 0704)

Tel Aviv, 6423906

Israel

Institut Català d'Oncologia (ICO) - Badalona ( Site 0904)

Badalona, Barcelona 08916

Spain

Hospital Virgen de la Victoria ( Site 0905)

Málaga, Malaga 29010

Spain

Hospital Universitari Vall de Hebron ( Site 0903)

Barcelona, 08035

Spain

Hospital Universitario Gregorio Maranon ( Site 0902)

Madrid, 28007

Spain

Hospital Universitario de Salamanca ( Site 0906)

Salamanca, 37007

Spain

Chang Gung Medical Foundation-Linkou Branch ( Site 1002)

Taoyuan, 333

Taiwan

Hacettepe Universite Hastaneleri ( Site 1110)

Ankara, 06230

Turkey (Türkiye)

Sisli Florence Nightingale Hastanesi ( Site 1112)

Istanbul, 34381

Turkey (Türkiye)

Ondokuz Mayıs Universitesi ( Site 1113)

Samsun, 55270

Turkey (Türkiye)