MK-1045 for follicular lymphoma and diffuse large B-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a combined Phase 1/2 interventional study evaluating MK-1045, an immunotherapy designed to help the immune system fight non-Hodgkin lymphoma. It targets patients with relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma who have limited previous options. Participants will receive MK-1045 and be monitored for safety, tolerability, and signs of anti-tumor activity. The study requires tumor tissue confirmation, prior therapy history, and, for some patients, documentation of CD19 expression and HIV control under ART. Locations include sites in Los Angeles, Denver, and Cleveland under Merck Sharp & Dohme LLC as lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has disease that has relapsed (disease progression after remission) or is refractory (failure to achieve complete or partial response) to at least 2 prior systemic lines of therapy.
* Has a histologically confirmed diagnosis of follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL).
* DLBCL participants only: has progressed after or is ineligible for transplant and chimeric antigen receptor T (cell) (CAR-T) therapy.
* Has provided tumor tissue sample (archival or newly obtained, if performed per standard of care).
* Has documented retained expression of cluster of differentiation 19 (CD19) in tumor tissue obtained by biopsy after disease progression on CD19-targeting therapy, if experienced disease progression after prior CD19-targeting therapy.
* Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if has a history of HIV infection.
* Has undetectable hepatitis B virus (HBV) viral load and received and will continue to receive HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.
* Has undetectable hepatitis C virus (HCV) viral load and received HCV antiviral therapy if has a history of HCV infection.
* Has radiographically measurable disease per Lugano Response Criteria.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has received a solid organ transplant.
* Had or has clinically relevant central nervous system (CNS) diseases.
* Has a history of serious cardiovascular or cerebrovascular diseases.
* Had prior allogenic stem cell transplantation with acute graft-versus-host-disease (GVHD); has ongoing evidence of chronic GVHD manifesting as skin involvement, diarrhea, or increased serum bilirubin; or requires systemic immunosuppression for GVHD.
* 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 of randomization.
* Has received prior CAR-T therapy within 3 months before the first dose of the study intervention.
* Has a known additional malignancy that is progressing or required active treatment within the past 2 years.
* Has known active CNS lymphoma or involvement.
* Has active autoimmune disease that required systemic treatment in the past 2 years.
* Has active infection requiring systemic therapy.
* Has a history of severe bleeding disorders.
* Has not recovered from major surgery or has ongoing surgical complications.
* Has diagnosis of primary mediastinal B-cell lymphoma.

Where it's running

• Cedar Sinai Cancer Center ( Site 0119)
  Los Angeles, California, United States Recruiting
• Colorado Blood Cancer Institute ( Site 7000)
  Denver, Colorado, United States Recruiting
• University Hospitals of Cleveland ( Site 0113)
  Cleveland, Ohio, United States Recruiting
• SCRI Oncology Partners ( Site 0100)
  Nashville, Tennessee, United States Recruiting
• Henry-Joyce Cancer Clinic ( Site 0115)
  Nashville, Tennessee, United States Recruiting
• Instituto Alexander Fleming ( Site 1404)
  Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina Recruiting

+4 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.