Study on Pembrolizumab, Ibrutinib, and Rituximab for Treating Recurrent Primary Central Nervous System Lymphoma (PCNSL)

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04421560

Provider View

This clinical trial is exploring a combination of three drugs—Pembrolizumab, Ibrutinib, and Rituximab—as a potential treatment for patients with primary central nervous system lymphoma (PCNSL) that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to test a combination of three drugs—Pembrolizumab, Ibrutinib, and Rituximab—to see if they can help treat primary central nervous system lymphoma (PCNSL) that has come back or not responded to other treatments. These drugs are being studied together to see if they can work better than current treatments for this type of cancer.

Description

This study is a Phase Ib/II trial, which means it is looking at both the safety and effectiveness of the drug combination. In Phase I, the focus is on finding a safe dose of the drugs. In Phase II, the study will look at how well the drugs work in treating the cancer.

The drugs being tested are:

  • Pembrolizumab: A type of drug called a monoclonal antibody that helps the immune system attack cancer cells.
  • Ibrutinib: A drug that blocks certain proteins that help cancer cells grow.
  • Rituximab: Another monoclonal antibody that works with the immune system to fight cancer.

These drugs are not yet approved by the FDA for treating PCNSL, but they are approved for other types of lymphoma. Participants in the study will receive these drugs for up to two years, as long as they do not experience serious side effects and their cancer does not worsen. After the study, participants will have follow-up visits every three months.

The study is supported by Merck & Co., Inc., which is providing funding and the drug Pembrolizumab for the research.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and sign a consent form.
  • Must be willing to follow the study schedule and procedures.
  • Must be at least 18 years old.
  • Must have a confirmed diagnosis of PCNSL that has returned or not responded to treatment.
  • Must have a performance status score of 0 or 1, indicating good overall health.
  • Must have a life expectancy of more than 3 months.
  • Must have stable side effects from previous treatments.
  • Must be able to undergo certain medical procedures like lumbar puncture.
  • Must have adequate organ function based on specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 120 days after.
  • Men must agree to use contraception during the study and for 120 days after.

Exclusion Criteria

  • Cannot undergo MRI of the brain.
  • Have received certain prior cancer treatments.
  • Have had a significant brain bleed.
  • Are taking certain blood thinners.
  • Have had recent blood clots or strokes.
  • Have active autoimmune diseases requiring treatment.
  • Have had recent major surgery or radiation therapy.
  • Have received a live vaccine recently.
  • Have another active cancer.
  • Have severe allergies to study drugs.
  • Have uncontrolled infections or heart conditions.
  • Have poorly controlled diabetes.
  • Have a history of certain infections like HIV or hepatitis.
  • Are pregnant or breastfeeding.

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