|

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

RECRUITINGPhase 2/3Sponsored by Merck Sharp & Dohme LLC
Actively Recruiting
PhasePhase 2/3
SponsorMerck Sharp & Dohme LLC
Started2026-06-22
Est. completion2032-07-23
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT07634471

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)

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

CancerFollicular Lymphoma

Interventions9

BendamustineCyclophosphamideDoxorubicin HydrochlorideMK-1045PrednisolonePrednisoneRituximabRituximab BiosimilarVincristine

Locations1 site

SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee, 37203
Study Coordinator844-482-4812

Find trials near these locations

Cancer trials in NashvilleAll trials in Tennessee

Related trials

Browse More Trials

Cancer trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.