A Phase II Study of Tremelimumab versus Placebo for Previously Treated Inoperable Mesothelioma

Protocol
13-092
Full Title
A Phase 2b Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second or Third-line Treatment of Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma
Phase
II
Purpose

Mesothelioma is a cancer of the peritoneum (lining of the abdomen) or pleura (lining of the lungs). The purpose of this study is to assess the safety and effectiveness of an investigational drug called tremelimumab in patients with peritoneal or pleural mesothelioma when it is given as the second or third therapy. Patients will be randomly assigned to receive tremelimumab (two-thirds of the patients) or a placebo (the remaining third); each will be given intravenously (by vein).

Tremelimumab is an antibody that blocks cytotoxic T lymphocyte antigen 4 (CTLA4), a protein found on cells of the immune system. CTLA4 puts the brakes on the immune response and may prevent immune cells from attacking cancer cells. Tremelimumab prevents this from happening, potentially enhancing the immune response against the cancer. Stimulating the immune system could be a different way of killing cancer cells.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable peritoneal or pleural mesothelioma that persists or has returned despite no more than two prior regimens of therapy that included a platinum-containing drug.
  • At least 2 weeks must have passed since completion of prior chemotherapy and radiation therapy and entry into the study.
  • Patients may not have had previous treatment with medications that target CTLA-4.
  • Patients with a history of chronic inflammatory or immune disease who had symptoms within the three years prior to entering the study may not participate.
  • Patients with chronic conditions causing frequent diarrhea, those receiving systemic steroids, and patients with a history of other cancer in the last three years may not participate.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Lee M. Krug at 646-888-4201.

Disease(s)
Mesothelioma
Locations
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