Trial Search Results

Phase 2 Multicohort Study to Evaluate the Safety and Efficacy of Novel Treatment Combinations in Patients With Recurrent Ovarian Cancer

This study is a phase 2, multi-cohort study, which will assess the safety and efficacy of new treatment combinations in patients with recurrent ovarian cancer.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Tesaro, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Niraparib
  • Drug: TSR-042
  • Drug: Bevacizumab

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Patient has histologically diagnosed high-grade recurrent epithelial (ie, serous,
   endometrioid, mucinous, clear cell) ovarian, fallopian tube, or primary peritoneal
   cancer or recurrent carcinosarcoma of the ovary. Patients with high-grade mixed
   histology are also eligible.

   - Patient has measurable disease according to RECIST v1.1

   - Patient has an ECOG performance status of 0 or 1

   - Patient has adequate organ function, defined as follows:

      1. Absolute neutrophil count ≥1,500/µL

      2. Platelets ≥100,000/µL

      3. Hemoglobin ≥9 g/dL

      4. Serum creatine ≤1.5x upper limit of normal (ULN) or calculated creatinine
      clearance ≥50mL/min using Crockcroft-Gault equation.

      5. Total bilirubin ≤1.5x ULN, except in patients with Gilbert's syndrome. Patients
      with Gilbert's syndrome may enroll if direct bilirubin is ≤1.5x ULN for the
      direct bilirubin.

      6. Asparate aminotransferase and alanine aminotransferase ≤2.5x ULN, unless liver
      metastases are present, in which case they must be ≤5x ULN

      7. International normalized ration or prothrombin time (PT) ≤1.5x ULN unless patient
      is receiving anticoagulant therapy as long as PT or partial thromboplastin time
      (PTT) is within therapeutic range of intended use of anticoagulants

      8. Activated partial thromboplastin time ≤1.5x ULN unless patient is receiving
      anticoagulant therapy as long as PT or PTT is within therapeutic range of
      intended use of anticoagulants.

   - Patient of childbearing potential is not breastfeeding, has a negative serum pregnancy
   test within 72 hours prior to taking study treatment, and agrees to abstain from
   activities that could result in pregnancy from enrollment through 180 days after the
   last dose of study treatment; or patient is of non-childbearing potential.

   - Patient is willing to undergo a pre-treatment tumor biopsy, unless an appropriate
   archival tumor tissue is available. Additionally, patient must be willing to undergo 1
   on-treatment biopsy, provided it is deemed safe and feasible by the Investigator.

For Cohort A, in addition to the general inclusion criteria, patients must also meet the
following additional criterion to be considered eligible to participate in this study:

   - Patient must be resistant to the most recent platinum-based therapy. Patients with
   primary platinum-refractory disease are not eligible.

   - Patient must not have received any prior therapy for ovarian cancer with a PARP
   inhibitor.

   - Patient has had 1 to 2 prior lines of anticancer therapy for ovarian cancer.

Exclusion Criteria (Patients will not be eligible for study entry if any of the following
criteria are met):

   - Patient has not recovered (ie, to Grade ≤1 or to baseline) from prior
   chemotherapy-induced adverse events.

   - Patient has a known diagnosis of immunodeficiency or is receiving systemic steroid
   therapy exceeding an equivalent of prednisone 10 mg daily or any other form of
   immunosuppressive therapy within 7 days prior to the first dose of study treatment

   - Patient is currently participating in a treatment study or has participated in a study
   of an investigational agent within 4 weeks of the first dose of treatment

   - Patient has received prior systemic anticancer therapy including cytotoxic
   chemotherapy, PARP inhibitor, immune checkpoint inhibitors, hormonal therapy given
   with the intention to treat ovarian cancer, or biological therapy within 3 weeks of
   the first dose of study treatment

   - Patient has received live vaccine within 30 days of planned start of study therapy

   - Patient has symptomatic uncontrolled brain or leptomeningeal metastases

   - Patient had major surgery within 4 weeks of starting the study

   - 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
   cancer that is considered to be low risk for progression by the investigator

   - Patient is considered a poor medical risk due to a serious, uncontrolled medical
   disorder, nonmalignant systemic disease, or active, uncontrolled infection

   - Patient has a history or current evidence of any condition, therapy or laboratory
   abnormality that might confound the results of the study, might interfere with the
   patient's participation for the full duration of the study treatment, or is not in the
   best interest of the patient to participate

   - Patient has known active hepatitis B or hepatitis C

For Cohort A, patients will not be eligible for study entry if the following additional
exclusion criteria are met:

   - Patient has known hypersensitivity to TSR-042, bevacizumab, niraparib, their
   components, or their excipients

   - Patient has a known history of myelodysplastic syndrome or acute myeloid leukemia

   - Patient has 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) is not
   considered a form of systemic treatment

   - Patient received prior treatment with an anti-PI-1 or anti-PD-L1 agent

   - Patient has received prior treatment with anti-angiogenic therapy with the exception
   of bevacizumab.

   - Patient has bowel obstruction, had bowel obstruction within the past 3 months, or is
   otherwise judged by the Investigator to be at high risk for bowel obstruction related
   to the underlaying disease.

   - Patient has proteinuria as demonstrated by urine protein: creatine ratio ≥1.0 at
   screening or urine dipstick for proteinuria ≥2

   - Patient is at increased bleeding risk due to concurrent conditions (eg, major injuries
   or surgery within the past 28 days prior to start of study treatment, history of
   hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically
   significant hemorrhage within the past 3 months)

   - Patient has a history of recent major thromboembolic event defined as follows:

      1. Pulmonary embolism diagnosed within 3 months of enrollment

      2. Lower extremity deep venous thrombosis diagnosed within 3 months of enrollment

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Renjini Balakrishnan
650-724-3308
Recruiting