A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
NCT07634471 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 960
Last updated 2026-08-07
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)
Conditions
Interventions
- BIOLOGICAL
-
MK-1045
Intravenous (IV) infusion
- BIOLOGICAL
-
IV infusion
- BIOLOGICAL
-
Rituximab biosimilar
IV infusion
- DRUG
-
IV infusion
- DRUG
-
IV infusion
- DRUG
-
Vincristine
IV infusion
- DRUG
-
Per approved product label
- DRUG
-
Prednisolone
Per approved product label
- DRUG
-
Doxorubicin Hydrochloride
IV infusion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-22
- Primary Completion
- 2032-07-23
- Completion
- 2035-07-23
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Israel
- Spain
- Taiwan
- Turkey (Türkiye)
Study Locations
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