Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC).

This is a single arm, open-label, phase II study to assess pathologic objective response rate
(complete response + partial response) in patients treated with pembrolizumab, paclitaxel and
carboplatin for advanced stage III or IV Ovarian, Fallopian Tube, or Peritoneal Carcinoma
(EOC).

Eligible patients will undergo tissue biopsies to confirm diagnosis, followed by 3 to 4
cycles of neoadjuvant chemotherapy (NACT).

Inclusion Criteria:

1. No prior treatment for primary advanced (Stage III or IV) high grade epithelial
ovarian, primary peritoneal, or fallopian tube carcinoma such as irradiation,
chemotherapy, hormonal therapy, immunotherapy, investigational therapy, and/or other
concurrent agents or therapies.

2. Patients must undergo diagnostic laparoscopy for disease assessment for tissue
biopsies to confirm diagnosis. For those not medically fit to undergo laparoscopy, as
determined by the Investigator, Interventional radiology (IR)-guided core biopsies may
be used

3. Tissue from an archival sample or newly obtained core or excisional biopsy of a tumor
lesion.

5. Age ≥ 18 years

6. Life expectancy > 3 months

7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

1. Patients who are currently in or have participated in a study of an investigational
agent or used an investigational device within 4 weeks of the first dose of treatment.

2. Histology showing mucinous or low grade epithelial ovarian cancer.

3. Patients who will not be likely to undergo interval tumor reductive surgery either
secondary to performance status or sites of disease. If at the time of surgery, the
patient is deemed to be surgically resectable to no gross residual, the patient will
not be eligible for the study.

4. Patients with known active central nervous system (CNS) metastases and/or
carcinomatous meningitis. Patients with previously treated brain metastases may
participate provided they are stable (without evidence of progression by imaging for
at least four weeks prior to the first dose of Study treatment and any neurologic
symptoms have returned to baseline), have no evidence of new or enlarging brain
metastases, and are not using steroids for at least 28 days prior to Study treatment.

5. Has a known additional malignancy that is progressing or requires active treatment.
Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the
skin, or in situ cervical cancer that has undergone potentially curative therapy.

6. Has received prior therapy with an anti-PD1, anti-PDL1, anti-CD137, anti-cytotoxic
T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other
antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
or anti-PDL2 agent.

7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

8. 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 study
treatment.