Phase II single arm, open label, nonrandomized study. The aim of our study is to assess the
Progression Free Survival (PFS) in suboptimally cytoreduced epithelial ovarian/ primary
peritoneal/ fallopian tube cancer patients treated with the novel combination of carboplatin
every 21 days (triweekly) /weekly paclitaxel IV with pembrolizumab IV followed by
maintenance pembrolizumab IV.
Utilization of combination standard intravenous chemotherapy with intravenous pembrolizumab
(for 6 cycles) in first line treatment of patients with advanced ovarian cancer post surgery
with any residual disease. This will be followed by single agent intravenous pembrolizumab
(every 3 weeks) for 12 additional cycles.
- Have advance stage III/IV epithelial ovarian, fallopian tube or primary peritoneal
- Be willing and able to provide written informed consent/assent for the trial.
- Be 18 years of age on day of signing informed consent.
- Have measurable/ macroscopic disease based on RECIST 1.1.
- Be willing to provide tissue from a newly obtained core or excisional biopsy of a
tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42
days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained
samples cannot be provided (e.g. inaccessible or subject safety concern) may submit
an archived specimen only upon agreement from the Sponsor.
- Have a performance status of 0, 1 or 2 on the ECOG Performance Scale.
- Demonstrate adequate organ function
- All screening labs should be performed within 10 days of treatment initiation.
- Female subject of childbearing potential should have a negative urine or serum
pregnancy within 72 hours prior to receiving the first dose of study medication.
- Female subjects of childbearing potential should be willing to use 2 methods of birth
control or be surgically sterile, or abstain from heterosexual activity for the
course of the study through 120 days after the last dose of study medication.
- Is currently participating and receiving study therapy or has participated in a study
of an investigational agent and received study therapy or used an investigational
device within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
other form of immunosuppressive therapy within 7 days prior to the first dose of
- Has a known history of active TB (Bacillus Tuberculosis)
- Hypersensitivity to pembrolizumab or any of its excipients.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study
Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events
due to agents administered more than 4 weeks earlier.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy
within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at
baseline) from adverse events due to a previously administered agent.
oNote: If subject received major surgery, they must have recovered adequately from the
toxicity and/or complications from the intervention prior to starting therapy.
- Has a known additional malignancy within the last 3 years, or that is progressing or
requires active treatment. Exceptions include basal cell carcinoma of the skin or
squamous cell carcinoma of the skin that has undergone potentially curative therapy
or in situ cervical cancer.
- Has known active central nervous system (CNS) metastases and/or carcinomatous
- Has active autoimmune disease that has required systemic treatment in the past 2
years (i.e. 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.
- Has known history of, or any evidence of active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the trial, interfere with the
subject's participation for the full duration of the trial, or is not in the best
interest of the subject to participate, in the opinion of the treating investigator.
- Patients with medical history or conditions not otherwise previously specified which
in the opinion of the investigator should exclude participation in this study. The
investigator should consult the Study Chair.
- Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive children within the projected
duration of the trial, starting with the pre-screening or screening visit through 120
days after the last dose of trial treatment.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA
[qualitative] is detected).
- Patients with borderline ovarian tumors, recurrent epithelial ovarian/ primary
peritoneal cancer/fallopian tube cancer or non-epithelial ovarian cancer are not
- Has received a live vaccine within 30 days of planned start of study therapy.