Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy

Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with
locally advanced or metastatic disease

2. Patients must be on treatment with platinum-based (cisplatin, oxaliplatin or
carboplatin) treatment for locally advanced or metastatic pancreatic cancer and have
received a minimum of 16 weeks of therapy without evidence of disease progression
based on the investigator's opinion

3. Patients may have previously failed non-platinum containing therapy or may never have
previously progressed on treatment.

-Discontinuation of the platinum component of the regimen for chemotherapy-related
toxicity is permissible provided the patient has previously received at least 16 weeks
of platinum-based therapy without evidence of disease progression ≤8 weeks after
treatment with the platinum agent

4. Measurable disease is not required for study entry

5. Adequate organ function

6. ECOG performance status of 0-1

Exclusion Criteria:

1. Prior treatment with a PARP inhibitor, ipilimumab, nivolumab or other cytotoxic
T-lymphocyte-associated protein (CTLA-4), PD-1 or PD-L1 inhibitor.

2. Patients who have demonstrated resistance to platinum agents (e.g. oxaliplatin,
cisplatin) are not eligible to participate in this study

3. Clinical evidence of uncontrolled malabsorption and/or any other gastrointestinal
disorder or defect that would, in the opinion of the investigator, interfere with the
absorption of niraparib

4. Received any systemic treatment for pancreatic cancer during the 14 days prior to
first dose of treatment

5. Acute infection requiring intravenous antibiotics, antiviral or antifungal agents
during the 14 days prior to first dose of study therapy.

6. Expected life expectancy of <12 weeks as determined by the investigator.

7. Patients will be excluded if they have an active, known or suspected autoimmune
disease, defined as: patients with a history of inflammatory bowel disease are
excluded from this study, as are patients with a history of symptomatic autoimmune
disease (eg rheumatoid arthritis, systemic progressive sclerosis (scleroderma),
systemic lupus erythematosus, autoimmune vasculitis eg Wegener's Granulomatosis);
motor neuropathy considered of autoimmune origin (eg Guillian-Barre Syndrome).

NOTE: Patients are permitted to enroll if they have vitiligo, type I diabetes
mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone
replacement, psoriasis not requiring systemic treatment, or conditions not expected to
recur in the absence of an external trigger.

8. Has a history of interstitial lung disease or active, non-infectious pneumonitis

9. Has received a live vaccine within 4 weeks prior to the first dose of trial therapy
(Note: seasonal influenza vaccines for injection are generally inactivated and are
allowed; however intranasal influenza vaccines (eg. Flu-Mist) are live attenuated
vaccines and are not allowed