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
- Follicular Lymphoma
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Merck Sharp & Dohme LLC
- Enrolment target
- 960
- Started
- 22 June 2026
- Main results due
- 23 July 2032
- Study sites
- 26
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
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)
Study sites(26)
City of Hope - Duarte Cancer Center ( Site 1301)
Duarte, California, United States
Recruiting
University of Kentucky ( Site 1303)
Lexington, Kentucky, United States
Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1311)
Hackensack, New Jersey, United States
Recruiting
Duke Cancer Center Clinic 1B/C Onc/Heme ( Site 1307)
Durham, North Carolina, United States
Recruiting
SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee, United States
Recruiting
Instituto Alexander Fleming ( Site 0105)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Recruiting
Hospital Aleman ( Site 0101)
Buenos Aires, Buenos Aires F.D., Argentina
Recruiting
Sanatorio Nuestra Senora del Rosario ( Site 0104)
Rosario, Santa Fe Province, Argentina
Recruiting
Hospital Privado Universitario de Córdoba ( Site 0102)
Córdoba, Argentina
Recruiting
Box Hill Hospital ( Site 0201)
Box Hill, Victoria, Australia
Recruiting
Beijing Cancer hospital ( Site 0501)
Beijing, Beijing Municipality, China
Recruiting
Fudan University Shanghai Cancer Center ( Site 0504)
Shanghai, Shanghai Municipality, China
Recruiting
Hadassah Medical Center ( Site 0701)
Jerusalem, Israel
Recruiting
Sheba Medical Center ( Site 0702)
Ramat Gan, Israel
Recruiting
Sourasky Medical Center ( Site 0704)
Tel Aviv, Israel
Recruiting
Samsung Medical Center ( Site 0801)
Seoul, South Korea
Recruiting
Institut Català d'Oncologia (ICO) - Badalona ( Site 0904)
Badalona, Barcelona, Spain
Recruiting
Hospital Virgen de la Victoria ( Site 0905)
Málaga, Malaga, Spain
Recruiting
Hospital Universitari Vall de Hebron ( Site 0903)
Barcelona, Spain
Recruiting
Hospital Universitario Gregorio Maranon ( Site 0902)
Madrid, Spain
Recruiting
Hospital Universitario de Salamanca ( Site 0906)
Salamanca, Spain
Recruiting
National Taiwan University Hospital ( Site 1001)
Taipei, Taiwan
Recruiting
Chang Gung Medical Foundation-Linkou Branch ( Site 1002)
Taoyuan, Taiwan
Recruiting
Hacettepe Universite Hastaneleri ( Site 1110)
Ankara, Turkey (Türkiye)
Recruiting
Sisli Florence Nightingale Hastanesi ( Site 1112)
Istanbul, Turkey (Türkiye)
Recruiting
Ondokuz Mayıs Universitesi ( Site 1113)
Samsun, Turkey (Türkiye)
Recruiting
Showing 26 of 26 sites. 26 of the 26 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07634471. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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