A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007) (NCT07634471) | Clinical Trial Compass
RecruitingPhase 2/3
A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
United States, Israel, Spain960 participantsStarted 2026-07-06
Plain-language 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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 diag…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: Number of Participants Who Experience an Adverse Event (AE)
Timeframe: Up to approximately 15 months
2
Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
Timeframe: Up to approximately 12 months
3
Part 1: Number of Participants Who Experience Dose Limiting Toxicity (DLT)