An Open-Label, Phase II Multicenter Study of Rituximab or Tocilizumab for Steroid-dependent or Steroid-refractory Immune-Related Adverse Events due to Immune Checkpoint Blockade.
Contact:
NCT Number:
Protocol:
AAAS9173
Study Status:
Active/Enrolling
Population:
Adult
Phase:
II
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.
Are you Eligible? (Inclusion Criteria)
- Have you been receiving steroids to manage an immune-related event while on
- immunotherapy for cancer?
- Are you 18 years of age or older?
- Are you willing to undergo extra tests and visits to the doctor?
Specialty Area(s)
Bladder Cancer , Colon and Rectal Cancer, Esophageal Cancer, Cervical Cancer, Head and Neck/Oral Cancers, Kidney Cancer/Adrenal Cancer, Liver Cancer, Lung cancer, Skin cancers, Melanoma, Pancreatic Cancer, Prostate Cancer, Sarcomas (Bone and Soft Tissue), Soft Tissue Sarcoma, Stomach Cancer
Principal Investigator
Trial Location(s)
CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032
