A Study of WT1 Vaccine and Nivolumab For Recurrent Ovarian Cancer

Inclusion Criteria:

- Pathologic diagnosis of ovarian, fallopian tube or primary peritoneal cancer confirmed
by pathology review at MSK.

- Patients will have relapsed at least once and returned to complete clinical remission
after additional chemotherapy. Interval surgery is permitted.

- Complete clinical remission is defined as CA-125 within normal limits, examination and
CT or MRI without objective evidence of disease (non specific abnormalities are
permitted on radiologic imaging).

- Patients may sign screening consent during recurrence or at time of remission if they
can start vaccine therapy within 4 months of completing chemotherapy.

- Testing of patient's archived (paraffin embedded, unstained slides) or freshly
biopsied tumor nodules must be positive for WT1 protein expression. WT1 expression:
Immunohistochemical analysis will be performed using the technique described by Dupont
et al [58]. WT1 expression will be graded according to an adaptation of the German
Immunoreactive Score (IRS). Only tumors with moderate to strong IRS scores (4-12) will
be considered WT1 positive.

- Age ≥ 18 years

- Karnofsky performance status ≥ 70%

- Hematologic parameters: Absolute neutrophil count ≥ 1000/mcL, Platelets > 50 K/mcL.

- Biochemical parameters: Total bilirubin ≤ 1.5 mg/dl, AST and ALT ≤ 2.5 x upper limits
of normal, Creatinine ≤ 1.5 mg/dl.

- Patient of childbearing potential must have a negative serum pregnancy test prior to
study entry and must be practicing and effective form of birth control

Exclusion Criteria:

- Pregnant or lactating women

- Patients with active infection requiring systemic antibiotics, antiviral, or
antifungal treatments

- Patients with a serious unstable medical illness or another active cancer.

- Patients with a condition requiring systemic treatment with either corticosteroids
(>10mg daily prednisone equivalents) or other immunosuppressive medications within 14
days of study drug administration. Inhaled or topical steroids and adrenal replacement
doses >10mg daily prednisone equivalents are permitted in the absence of active
autoimmune disease.

- Patients with known history of testing positive for human immunodeficiency virus (HIV)
or known acquired immunodeficiency syndrome (AIDS).

- Patients with known active hepatitis B virus or hepatitis C virus acute or chronic
infection.

- Patients with active known or suspected autoimmune disease (treated hypothyroidism is
permitted to enroll)

- Patients with active interstitial pneumonitis.