Study on MK-1045 and Rituximab for Treating Follicular Lymphoma

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT07634471

Provider View

This clinical trial is exploring a new treatment combination of MK-1045, an immunotherapy drug, and rituximab to see if it can effectively treat follicular lymphoma, a type of blood cancer. The study aims to determine if this combination is safe, helps the cancer go away, and allows patients to live longer without the cancer worsening compared to standard treatments.

Patient Parameters

Program Overview

Researchers are testing a new treatment for follicular lymphoma (FL), a type of blood cancer. The usual treatment includes rituximab and chemotherapy. This study is investigating if combining a new drug, MK-1045, with rituximab can be more effective. MK-1045 is a type of immunotherapy that helps the immune system fight cancer. The study's goals are to see if this combination is safe, if it can make the cancer disappear, and if it helps patients live longer without the cancer getting worse compared to the standard treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with classical follicular lymphoma (FL) that is CD19-positive and CD20-positive, and has not been treated before.
  • Cancer is at an advanced stage (Stage II-IV) and has a specific risk score (FLIPI score of 2-5).
  • Has a tumor that can be measured by scans.
  • Provided a recent biopsy or tissue sample from a tumor that hasn't been treated with radiation.
  • If HIV-positive, must have well-controlled HIV with medication.
  • If hepatitis B positive, must have an undetectable viral load and be on antiviral therapy.
  • If previously infected with hepatitis C, must have an undetectable viral load.

Exclusion Criteria

  • Has received any previous cancer treatment for follicular lymphoma.
  • Has a different type of follicular lymphoma or a more aggressive form.
  • Has a history of serious brain or nerve diseases.
  • Has serious heart or blood vessel diseases.
  • Has HIV with a history of certain related diseases.
  • Has received a live vaccine within 30 days before starting the study.
  • Has an immune deficiency or is on long-term steroid treatment.
  • Has another active cancer that needed treatment in the last 3 years.
  • Has active lymphoma in the brain or central nervous system.
  • Has an active autoimmune disease needing treatment in the last 2 years.
  • Has an active infection needing treatment.
  • Has severe liver disease.
  • Has not fully recovered from major surgery or has ongoing complications.

Locations

FACILITYZIPCITYSTATE
SCRI Oncology Partners ( Site 7000)37203NashvilleTennessee

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