Study on Nemtabrutinib and Pembrolizumab for Treating Richter Transformation, Diffuse Large B-cell Lymphoma

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT06863402

Provider View

This clinical trial is exploring a new treatment using nemtabrutinib and pembrolizumab to help fight a type of cancer called Richter transformation, diffuse large B-cell lymphoma (RT-DLBCL). The study aims to see if this combination can effectively kill cancer cells and improve patient outcomes.

Patient Parameters

Program Overview

This phase II study is testing how well a combination of two drugs, nemtabrutinib and pembrolizumab, works in treating patients with a specific type of cancer called Richter transformation, diffuse large B-cell lymphoma (RT-DLBCL). Nemtabrutinib is a kinase inhibitor that blocks a protein found at high levels in certain cancer cells, which may help stop the cancer from growing and spreading. Pembrolizumab is an immunotherapy drug that helps the immune system attack cancer cells. The study aims to find out if using these two drugs together can kill more cancer cells in patients with RT-DLBCL.

Description

The main goal of this study is to see how effective the combination of nemtabrutinib and pembrolizumab is in treating RT-DLBCL by measuring the overall response rate after 6 cycles of treatment. Secondary goals include evaluating the complete response rate, how long the response lasts, progression-free survival, and overall survival. The study will also assess the safety and side effects of the treatment, as well as how it affects patients' quality of life and symptoms.

Researchers will also explore how the treatment affects certain immune cells in the blood and its impact on CAR T-cells, which are a type of cancer treatment. They will also look at the molecular characteristics of the cancer to see how they relate to treatment outcomes.

Participants will take nemtabrutinib by mouth once a day for 21 days in each cycle and receive pembrolizumab through an IV on the first day of each cycle. Each cycle lasts 21 days, and treatment can continue for up to 35 cycles (about 2 years) unless the cancer progresses or side effects become too severe. Patients will have various tests, including heart scans, PET/CT scans, and blood tests, throughout the study. After finishing the treatment, patients will be followed up for up to 5 years to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of Richter transformation, diffuse large B-cell lymphoma (RT-DLBCL) from chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Cannot receive standard anthracycline-based chemoimmunotherapy or have disease progression after previous treatment for RT-DLBCL.
  • Must have recovered from side effects of previous cancer treatments to a certain level.
  • Have measurable disease as shown by imaging tests.
  • Be able to swallow pills.
  • Be 18 years or older.
  • Have a performance status score of 0-2, indicating good overall health.
  • Have no other active cancers within the last 2 years, except for certain low-risk cancers.
  • Meet specific blood count and organ function requirements.
  • HIV-positive patients may be eligible if they meet certain criteria, including a stable antiretroviral regimen.
  • Hepatitis B and C patients may be eligible if their viral loads are undetectable and they are on appropriate antiviral therapy.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for 6 months after.
  • Understand the study and agree to sign informed consent.

Exclusion Criteria

  • Have received previous treatment with certain immune checkpoint inhibitors or other specific cancer therapies.
  • Have had recent cancer treatments or live vaccines within a specified time before starting the study.
  • Have a diagnosis of immunodeficiency or are on high-dose steroids or other immunosuppressive therapy.
  • Have another active cancer or untreated brain metastases.
  • Have severe allergies to pembrolizumab or its ingredients.
  • Have active autoimmune diseases requiring treatment in the past 2 years.
  • Have a history of lung disease requiring steroids.
  • Have an active infection needing treatment.
  • Have not fully recovered from major surgery.
  • Have conditions that could interfere with the study or are not in the best interest of the participant.
  • Have uncontrolled illnesses or conditions that limit compliance with the study.
  • Are pregnant or breastfeeding, or plan to conceive or father a child during the study and for a period after.
  • Have received another investigational drug recently.
  • Have a history of certain bleeding disorders or psychiatric conditions that interfere with the study.
  • Have had an organ transplant, except for certain stem cell transplants.

Locations

FACILITYZIPCITYSTATE
Roswell Park Cancer Institute14263BuffaloNew York

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