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

Status
Completed
Cancer Type
Breast Cancer
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT02657889
Protocol IDs
3000-PN162-01-001 (primary)
NCI-2016-00219
Study Sponsor
Tesaro Inc

Summary

This Phase 1/2 study will evaluate the safety and efficacy of combination treatment with
niraparib and pembrolizumab (MK-3475) in patients with advanced or metastatic
triple-negative breast cancer or recurrent ovarian cancer. (KEYNOTE-162)

Eligibility

  1. Patient has histologically proven advanced (unresectable) or metastatic cancer as outlined below according to study phase and disease type:
  2. Phase 1 patients (breast or ovarian cancer)
  3. Patients with advanced or metastatic breast cancer must have disease that is HER2-negative, estrogen receptor-negative, and progesterone receptor-negative (ie, TNBC). Patients with advanced or metastatic disease may have up to 4 lines of cytotoxic therapy. Neoadjuvant and adjuvant therapies are not counted towards lines of therapy.
  4. Patients must have any epithelial (ie, serous, endometroid, mucinous, clear cell) ovarian, fallopian tube, or primary peritoneal cancer. Patients must have experienced a response lasting at least 6 months to first-line platinum-based therapy but currently considered to have platinum-resistant disease per investigator's assessment (e.g, patient is not eligible for further platinum containing treatment). Patients may have received up to 5 lines of cytotoxic therapy for advanced or metastatic cancer. Neoadjuvant and adjuvant therapies are not counted towards lines of therapy.
  5. Phase 2 patients (breast or ovarian cancer)
  6. Patients with advanced or metastatic breast cancer must have TNBC. Patients with advanced or metastatic disease may have received up to 2 lines of cytotoxic therapy. Adjuvant and/or neoadjuvant therapies are not counted in the number of lines of therapy. TNBC patients who have previously received platinum chemotherapy in the metastatic setting are allowed to enroll in the study as long as they did not progress while on or within 8 weeks from the day of the last platinum administration.
  7. Patients must have with high-grade serous or endometroid ovarian, fallopian tube, or primary peritoneal cancer. Patients must have experienced a response lasting at least 6 months to first-line platinum-based therapy but currently considered to have platinum-resistant disease per investigator's assessment (e.g, patient is not eligible for further platinum containing treatment). Patients may have had up to 4 lines of cytotoxic therapy for advanced or metastatic cancer. Neoadjuvant, adjuvant, and the combination of both will be considered as one line of therapy.
  8. Archival tumor tissue available or a fresh biopsy must be obtained prior to study treatment initiation
  9. Measurable lesions by RECIST v1.1
  10. Eastern Cooperative Oncology Group (ECOG) 0 or 1
  11. Adequate organ function
  12. Able to take oral medications
  13. Female patient, if of childbearing potential, has a negative serum pregnancy test within 72 hours of taking study medication and agrees to abstain from activities that could result in pregnancy from enrollment through 120 days after the last dose of study treatment
  14. Male patient agrees to use an adequate method of contraception Main
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.