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Study of Pembrolizumab With or Without CC-486 in Patients With Platinum-resistant Ovarian Cancer

This study is open to:

Patients can enroll if they:

  • Have Epitheilial Ovarian Cancer (EOC), Fallopian Tube Cancer (FTC) or Primary Peritoneal Cancer (PPC).
  • Received debulking surgery and preoperative and/or postoperative platinum-based frontline chemotherapy (intravenous and/or intraperitoneal) for the treatment of EOC/FTC/PPC.
  • Documented platinum-resistant or platinum-refractory disease. 
  • Measurable disease
  • Indication of systemic treatment for the relapsed EOC, FTC or PPC.
  • Subjects must have a tumor lesion that is amenable to an image-guided core biopsy and willingness to undergo two biopsies (baseline and 6 weeks after first dose of study treatment).
This study is not open to:

Patients will be excluded if they:

  • they have non-epithelial ovarian cancers, including malignant mixed Müllerian tumors.
  • Ovarian tumors with low malignant potential (i.e. borderline tumors).
  • Relapse/progression based solely on elevation of CA-125, in absence of measurable disease.
  • More than 2 prior treatment regimens for the platinum-resistant/refractory relapsed EOC, FTC, or PTC, defined as investigational, chemotherapy, hormonal, biologic, or targeted therapy.
  • A subject with previous history of invasive malignancy (other than adequately and radically treated basal or squamous skin cancer or carcinomas in situ) is eligible provided that she has been disease free for more than 5 years.
  • Brain metastases (even if treated and/or stable), spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
  • Prior systemic anticancer therapy within 4 weeks prior to enrollment or who has not recovered (i.e. ≤ Grade 1 or baseline grade) from adverse events due to a previously administered agent
  • Prior treatment with a monoclonal antibody within 4 weeks prior to enrollment or who has not recovered (i.e. ≤ Grade 1 or baseline grade) from adverse events due to agents administered more than 4 weeks earlier.
  • Prior treatment with any anti-Programmed Death (PD)-1, or PD-L1 or PD-L2 agent; or with azacitidine (any formulation) or any other hypomethylating agent; or with anti-cytoplasmic (CD) 137, or anti-cytotoxic T-Lymphocyte Associated Protein (CTLA)-4 antibody (including ipilimumab) or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
Study of Pembrolizumab With or Without CC-486 in Patients With Platinum-resistant Ovarian Cancer

Study of Pembrolizumab With or Without CC-486 in Patients With Platinum-resistant Ovarian Cancer

Clinicaltrials.gov identifier:
NCT02900560

Study Contact Information

Contact: John Glaspy, MD 310-794-0066 jglaspy@mednet.ucla.edu
Contact: Christy Palodichuk 310-794-2971 Cpalodichuk@mednet.ucla.edu

About the Study

The purpose of the study is to determine the best dosing schedule for the oral drug CC-486 (oral azacitidine) in combination with the immuno-oncology agent pembrolizumab (Keytruda) for the treatment of platinum-resistant/refractory Epithelial Ovarian Cancer (EOC).

Type of Study

This is an open-label, non-randomized, four-cohort study.

  • The study is open-label. All participating patients will receive the study agent and will know which group they will be assigned to. 
  • The study is non-randomized, meaning that patients will be assigned to one of four groups based on when they enrolled in the study.
    • Eligible subjects will be treated in one of four groups of oral CC-486 combined with intravenous pembrolizumab. Each group will receive a different dosing schedule of CC-486 while receiving the same dose of intravenous pembrolizumab (200 mg IV). 

What Study Entails

  • Patients with platinum resistant ovarian, fallopian tube, and primary peritoneal cancer will be assigned to one of four different schedules of administration of CC-486 (oral azacitidine). All patients will also receive Pembrolizumab 200 mg IV every 21 days
    • CC-486 100 mg once a day, 21 days on, 7 days off 
    • CC-486 100 mg twice a day, 21 days on, 7 days off
    • CC-486 300 mg once a day, 14 days on and 14 days off
    • CC-486 300 mg once a day, 21 days on, 7 days off 
  • Subjects will be assigned to a treatment cohort in the order they are enrolled in the study.
  • In all subjects, tumor tissue will be obtained via image-guided core biopsy at study entry and 6 weeks after commencing treatment with CC-486. 
  • Subjects will be treated in the assigned cohort until progressive disease. 
  • This study includes mandatory tumor core biopsies for biomarkers research and mandatory whole blood sampling for deoxyribonucleic acid (DNA) methylation analyses.

Study Sites

  • California, Los Angeles
    UCLA
    Principal Investigator: John Glaspy, MD
    Phone: 310-794-0066 or by email

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