RECRUITING Phase 2 / Phase 3 ClinicalTrials.gov

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

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07634471

Registry updated: 2026-10-15

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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)

Interventions

MK-1045 (Biological)
Intravenous (IV) infusion
Rituximab (Biological)
IV infusion
Rituximab biosimilar (Biological)
IV infusion
Bendamustine (Drug)
IV infusion
Cyclophosphamide (Drug)
IV infusion
Vincristine (Drug)
IV infusion
Prednisone (Drug)
Per approved product label
Prednisolone (Drug)
Per approved product label
Doxorubicin Hydrochloride (Drug)
IV infusion

Eligibility criteria

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.

Conditions

Follicular Lymphoma

Locations

City of Hope - Duarte Cancer Center ( Site 1301) — Duarte, California, United States
University of Kentucky ( Site 1303) — Lexington, Kentucky, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1311) — Hackensack, New Jersey, United States
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
Hospital Aleman ( Site 0101) — Buenos Aires, Buenos Aires F.D., Argentina
Sanatorio Nuestra Senora del Rosario ( Site 0104) — Rosario, Santa Fe Province, Argentina
Hospital Privado Universitario de Córdoba ( Site 0102) — Córdoba, Argentina
Box Hill Hospital ( Site 0201) — Box Hill, Victoria, Australia
Biocenter ( Site 0402) — Concepción, Biobio, Chile
Fundacion Arturo Lopez Perez FALP ( Site 0404) — Santiago, Region M. de Santiago, Chile
Beijing Cancer hospital ( Site 0501) — Beijing, Beijing Municipality, China
Fudan University Shanghai Cancer Center ( Site 0504) — Shanghai, Shanghai Municipality, China
Evangelismos General Hospital of Athens ( Site 1501) — Athens, Attica, Greece
General Hospital of Athens "Laiko" ( Site 1502) — Athens, Attica, Greece
Hadassah Medical Center ( Site 0701) — Jerusalem, Israel
Sheba Medical Center ( Site 0702) — Ramat Gan, Israel
Sourasky Medical Center ( Site 0704) — Tel Aviv, Israel
INOC - Istituto Nazionale Oncologico Candiolo ( Site 1602) — Candiolo, Torino, Italy
Pratia MCM Krakow ( Site 1702) — Krakow, Lesser Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1701) — Warsaw, Masovian Voivodeship, Poland
Samsung Medical Center ( Site 0801) — Seoul, South Korea
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)

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment