An Open-Label, Phase II Multi-center Study of Rituximab or Tocilizumab for Steroid Dependent Immune-Related Adverse Events Due to Immune Checkpoint Blockade
Study of Rituximab or Tocilizumab for Patients With Steroid-Dependent Immune-Related Adverse Events (irAEs)
Sponsor: Genentech
Enrolling: Male and Female Patients
IRB Number: AAAS9173
U.S. Govt. ID: NCT04375228
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of this study is to determine the safety and effectiveness of two drugs, either rituximab or tocilizumab, in patients who develop side effects while on treatment with immunotherapy requiring prolonged steroids. Immune-related side effects are caused by activation of the immune system from treatment with immunotherapy. Both rituximab and tocilizumab have been given to patients with autoimmune diseases (diseases where the immune system is activated against normal organs). Immune-related side effects appear to closely mirror these autoimmune conditions. Cancers include: Bladder cancer, esophageal cancer, colon/rectal cancer, cervical cancer, kidney/adrenal cancer, lung cancer, head/neck cancers, liver cancer, skin cancer, sarcomas, pancreatic cancer, stomach cancer, and prostate cancer.
Investigator
Brian Henick, MD
Do You Qualify?
Are you 18 years of age or older? Yes No
Have you been receiving steroids to manage an immune-related event while on immunotherapy for cancer? Yes No
Are you willing to undergo extra tests and visits to the doctor? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162