Phase II Study of Pembrolizumab with SOC Treatment in Recurrent Ovarian Cancer

Condition/Intervention

  • Ovarian cancer

Study Name

IIT2015-13-Walsh-PemCiGem: A Phase II Study of Pembrolizumab with Cisplatin and Gemcitabine Treatment in Patients with Recurrent Platinum-Resistant Ovarian Cancer

Phase

Phase II

Summary:

The purpose of this study is to examine the investigational use of a drug called pembrolizumab in women with recurring ovarian cancer. The study will evaluate the effectiveness and safety of the combination of pembrolizumab with standard-of-care treatment. Pembrolizumab works with the immune system to target tumors. Researchers hope to determine whether pembrolizumab in combination with standard chemotherapy drugs (gemcitabine and cisplatin) is effective in destroying cancer cells.

Pembrolizumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of a type of lung and skin cancer. However, it is not approved by the FDA for the treatment of ovarian cancer.

Key Inclusion Criteria

  • Willing and able to provide written informed consent
  • At least 18 years old
  • Diagnosis of recurrent epithelial ovarian, peritoneal or fallopian tube carcinoma that has progressed within six months of prior cytotoxic chemotherapy
  • Have measurable disease based on Response Evaluation Criteria in Solid Tumors

Key Exclusion Criteria

  • Currently receiving study therapy or has participated in a study of an investigational agent within four weeks of the first dose of treatment
  • Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within seven days prior to the first dose of trial treatment
  • Known history of active bacillus tuberculosis

Please see complete list of inclusion and exclusion criteria.

Principal Investigator

Christine Walsh, MD

Co-Investigators Include

Ilana Cass, MD
Beth Karlan, MD
Andrew Li, MD
Ronald Leuchter, MD
Bobbie Rimel, MD

Study Coordinator and Contact

Meredith Axtell
Phone: 310-423-6595
Email: meredith.axtell@cshs.org

Status

Active

IRB No.

42519

Date Last Updated:

01/16