Study on Zilovertamab Vedotin as a Single Treatment and in Combination for Aggressive and Slow-Growing B-cell Blood Cancers

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05458297

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, zilovertamab vedotin, both on its own and combined with other treatments, for patients with certain types of B-cell blood cancers, including mantle cell lymphoma, Richter's transformation lymphoma, follicular lymphoma, and chronic lymphocytic leukemia.

Patient Parameters

Program Overview

The study aims to evaluate how safe and tolerable zilovertamab vedotin is when used alone or with other treatments in patients with specific B-cell lymphomas. These include aggressive types like mantle cell lymphoma (MCL) and Richter's transformation lymphoma (RTL), as well as slower-growing types like follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL). The study will also look at how well the drug works in shrinking tumors. Participants are divided into different groups based on their type of cancer and previous treatments.

Eligibility Criteria

Inclusion Criteria

  • For aggressive B-cell cancers like MCL: Must have a confirmed diagnosis and have tried at least two previous treatments, including a specific type of drug called BTKi, and either have had CAR-T cell therapy or are not eligible for it.
  • For MCL in Cohort C: Must have a confirmed diagnosis and have tried at least one previous treatment without prior exposure to a non-covalent BTKi.
  • For RTL: Must have a confirmed diagnosis and have tried at least one previous treatment.
  • For slower-growing B-cell cancers like FL and CLL: Must have a confirmed diagnosis and have tried at least two previous treatments with no other available options.
  • Participants with hepatitis B can join if they have been on antiviral therapy for at least four weeks and have no detectable virus.
  • Must have a performance status score of 0 to 2, indicating good overall health.

Exclusion Criteria

  • Have had a solid organ transplant.
  • Have serious heart conditions like recent stroke, heart attack, unstable chest pain, heart failure, or serious heart rhythm problems.
  • Have fluid around the heart or lungs that is causing symptoms.
  • Have ongoing severe nerve damage.
  • Have a specific nerve disease called Charcot-Marie-Tooth disease.
  • Have had another cancer unless treated and cancer-free for two years.
  • Have follicular lymphoma that has changed to a more aggressive type.
  • Have had cancer treatment recently, including certain drugs or radiation.
  • Are on high doses of steroids.
  • Have had a live vaccine recently.
  • Have active cancer in the brain or central nervous system.
  • Have an active infection needing treatment.
  • Have HIV, active hepatitis B, or hepatitis C.
  • For Cohort C only: Have significant digestive issues that affect drug absorption.

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