drugset / Trial / NCT04781855

Ipilimumab, Ibrutinib, and Nivolumab for the Treatment of Chronic Lymphocytic Leukemia and Richter Transformation

NCT04781855

Phase 1 Withdrawn M.D. Anderson Cancer Center
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase I/Ib trial evaluates the best dose and side effects of ipilimumab in combination with either ibrutinib alone or with ibrutinib and nivolumab in treating patients with chronic lymphocytic leukemia (CLL) and Richter transformation (RT). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ipilimumab with either ibrutinib alone or with ibrutinib and nivolumab may help control CLL and RT.

Timeline

Start
2022-07-14
Primary completion
2025-02-21
Completion
2025-02-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibrutinib Small molecule Oral
Subject Ipilimumab Monoclonal antibody Intravenous
Subject Nivolumab Monoclonal antibody Intravenous