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Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer (TOPACIO)

Title Phase 1/2 Clinical Study of Niraparib in Combination with Pembrolizumab in Patients with Advanced or Metastatic Triple-Negative Breast Cancer and in Patients with Recurrent Ovarian Cancer
Therapeutic Area Breast Cancer, Ovarian Cancer
Principal Investigator John Erban, MD
Min Age 18 Years
Gender All
Contact Madeleine Arthur
More Information


The purpose of this study is to test the effectiveness of the combination of niraparib and pembrolizumab in patients with triple negative breast cancer or ovarian cancer.

Study Details

Inclusion Criteria

  • Triple negative breast cancer or platinum resistant ovarian cancer
  • Otherwise normal organ function

Exclusion Criteria

  • No nursing or pregnant women
  • No prior exposure to niraparib, pembrolizumab, or other similar drugs (PARP inihibitors or PD1/PDL1 inhibitors)
  • No complicating diseases and disorders including but not limited to: other cancers requiring treatment in the last two years, significant heart disease, active infection, or autoimmune diseases requiring systemic steroids.

Study Requirements

Subjects will have the following screening tests: medical history, physical exam, vital signs, CT of the chest, abdomen, and pelvis, ECG, blood and urine tests for safety, blood collection for research, and a tumor biopsy (only if there is no leftover tissue from a prior surgery or biopsy). The study drugs are niraparib (a pill that you swallow daily) and pembrolizumab (a drug infused or given in a vein over 30 minutes). On the first day of study drug, blood will be collected for research at 3 time points (called PK samples), pembrolizumab will be administered (over 30 minutes), then niraparib will be administered, and an ECG will be done. Subjects will be given niraparib to take daily at home. One week and two weeks after the very first dose, blood tests will be done for safety. Pembrolizumab will be administered three weeks after the first dose, and every three weeks thereafter (every three weeks is called a cycle). On days when subjects receive pembrolizumab infusions, they should wait to take their niraparib in the clinic and will also have the following tests: vital signs, blood tests for safety, and a symptom assessment. ECGs will be repeated at cycles 2, 4, and 8. CT scans will be done every 9 weeks. Subjects can continue to take niraparib and pembrolizumab until progression, up to a maximum of 2 years. A month after stopping the study drugs, subjects will come to clinic and have the following tests: physical exam, vital signs, and blood tests for safety. Thereafter, subjects will be contacted by phone every 3 months to see if they have started any other cancer treatment.