A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
Key facts
- Where
- Candiolo and Rome, ItalySee the 2 sites
- Phase
- Phase 2/3
Where in Italy
- Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCSCandiolo, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT07634471EU 2025-522777-10-00
- Record updated
- 10 November 2026
- Original 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.Read full original descriptionShow less
A Phase 2/3 Randomized, Open-label Study of MK-1045 in Combination With Rituximab in Participants With 1L Follicular Lymphoma
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)
Inclusion: 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: Has received prior systemic anticancer therapy or radiotherapy for FL; 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 not adequately recovered from major surgery or has ongoing surgical complications; 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 a known additional malignancy that is progressing or has required active treatment within the past 3 years; 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 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; Has known active CNS lymphoma or involvement.