A Phase II Study of Ipilimumab after Completion of Chemotherapy in Women with Recurrent Platinum-Sensitive Ovarian Cancer with Measurable Residual Disease

Protocol
12-152
Full Title
A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects
Phase
II
Purpose

Some women with ovarian, fallopian tube, or primary peritoneal cancer have cancer cells remaining after treatment with chemotherapy. In this study, researchers are evaluating the safety and effectiveness of the drug ipilimumab in these patients. Ipilimumab is approved for treating advanced melanoma, but its use in this study is considered investigational.

Ipilimumab is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down. Researchers believe that one way cancers can escape the immune system could be through this shut-down mechanism. An antibody against CTLA-4 could stop it from turning off the immune system, and allow an immune reaction to continue. This immune reaction may help the body to destroy remaining cancer cells.

Eligibility

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

  • Patients must have residual ovarian, fallopian tube, or primary peritoneal cancer remaining after chemotherapy that included at least two platinum-based chemotherapy regimens (to which the cancer was sensitive) and a taxane.
  • The cancer must have returned 6 months or more after completion of the first regimen of platinum-based chemotherapy.
  • Patients must be treated on the study within 12 weeks of completing their last regimen of chemotherapy.
  • 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.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Rachel Grisham at 646-888-4653.

Disease(s)
Ovarian Cancer
Locations
Related Diseases