Trial Search Results

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

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)

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Tesaro, Inc.

Collaborator: Merck Sharp & Dohme Corp.

Stanford Investigator(s):

Intervention(s):

  • Drug: niraparib
  • Biological: pembrolizumab

Phase:

Phase 1/Phase 2

Eligibility


Main Inclusion Criteria:

   - Patient has histologically proven advanced (unresectable) or metastatic cancer as
   outlined below according to study phase and disease type:

      1. Phase 1 patients (breast or ovarian cancer)

         - 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.

         - 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.

      2. Phase 2 patients (breast or ovarian cancer)

         - 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.

         - 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.

   - Archival tumor tissue available or a fresh biopsy must be obtained prior to study
   treatment initiation

   - Measurable lesions by RECIST v1.1

   - Eastern Cooperative Oncology Group (ECOG) 0 or 1

   - Adequate organ function

   - Able to take oral medications

   - 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

   - Male patient agrees to use an adequate method of contraception

Main Exclusion Criteria:

   - Patients with primary platinum refractory ovarian cancer (ie, progressive disease on
   or within 6 months of first-line platinum therapy)

   - Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
   Note: Patients previously treated for brain metastases may be able to participate
   provided they are stable

   - Patient has a known additional malignancy that progressed or required active treatment
   within the last 2 years. Exceptions include basal cell carcinoma of the skin, squamous
   cell carcinoma of the skin that has undergone potentially curative therapy, or in situ
   cervical cancer

   - Poor medical risk

   - Condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or
   laboratory abnormality that might confound the study results, or interfere with the
   patient's participation for the full duration of the study treatment.

   - Pregnant or breastfeeding, or expecting to conceive children within the projected
   duration of the study

   - Immunodeficiency or is receiving systemic steroid therapy or any other form of
   immunosuppressive therapy within 7 days prior to the first dose of study treatment

   - Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)

   - Known active hepatitis B or hepatitis C

   - Active autoimmune disease that has required systemic treatment in the past 2 years
   (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive
   drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid
   replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
   form of systemic treatment

   - Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

   - Prior treatment with a known poly(ADP-ribose) polymerase (PARP) inhibitor

   - Heart-rate corrected QT interval (QTc) prolongation > 470 msec at screening

   - Known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid
   leukemia (AML)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting