Nivolumab With or Without Ipilimumab in Treating Participants With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to 1 of 3
groups, depending on when you join the study.

Group 1 will receive nivolumab alone to help researchers find the safest dose that can be
given through the abdomen. Up to 3 dose levels will be tested. Up to 12 participants total
will take part in Group 1. The dose of nivolumab you receive will depend on when you join the
study and the side effects seen in other doses being tested. The study doctor will tell you
which dose of nivolumab you are receiving.

Group 2 will receive nivolumab and ipilimumab to determine the safest doses for both drugs
when delivered together into the abdomen. Up to 4 dose levels of ipilimumab will be tested.
Up to 24 participants will take part in this group. The dose of ipilimumab you receive will
depend on when you join the study and the side effects seen in other doses being tested. The
study doctor will tell you which dose of ipilimumab you are receiving.

Your dose of nivolumab will not change.

Group 3 will receive both nivolumab and ipilimumab at the doses determined to be safest based
on the results of Groups 1 and 2. Up to 12 participants will take part in this group.

Study Drug Administration:

You will have an IP port placed into your abdomen. This port will remain in place throughout
the study for delivery of the nivolumab and/or ipilimumab and to collect fluid for research
testing as indicated below under "Study Visits." The port will be removed after you have
received your last dose of study drug(s). You will sign a separate consent form for the IP
port's placement and removal.

You will receive nivolumab and/or ipilimumab as an IP infusion through the IP port over about
60 minutes each time. You will receive nivolumab on Days 1, 15, and 29 of each 6-week study
cycle. If you are in Groups 2 or 3, you also will receive ipilimumab on Day 1 of each cycle.

Length of Study:

You may continue to receive the study drug(s) as long your doctor thinks that you are
receiving benefit. You will no longer be able to take the study drug(s) if the disease gets
worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation in this study will be over after follow-up (described below).

Study Visits:

On Days 1, 15, and 29 of Cycle 1:

- You will have a physical exam.

- Blood (about 3 tablespoons) will be drawn for routine, transcriptonomics testing,
biomarker testing (Day 1 only), pharmacokinetic (PK) testing, and antibody testing.
Transcriptonomics testing checks for changes in your DNA (genetic material). PK testing
measures the amount of study drug in the body at different time points. Antibodies are
created by the immune system and may attack foreign cells or substances, such as the
study drug.

- Fluid from your abdomen will be collected through the IP port for PK testing.

- On Day 1 only, if you can become pregnant, part of the above blood sample will be used
for a pregnancy test.

On Day 2 of Cycle 1, blood (about 2 tablespoons) will be drawn for PK, transcriptomics and
antibody testing.

If you are in Groups 1 or 2, on Days 4, 8, and 22 of Cycle 1, blood (about 2 tablespoons)
will be drawn for PK and antibody testing.

On Days 1, 15, and 29 of Cycles 2 and beyond:

- You will have a physical exam.

- Blood (about 3 tablespoons) will be drawn for routine tests, PK testing (Day 1 of Cycle
2 only) and for biomarker testing (Day 1 only).

- On Days 1, 15, and 29 of Cycle 2 and then Day 1 of Cycles 3 and beyond, this sample will
be used for transcriptonomics testing.

- Fluid from your abdomen will be collected during Cycle 2 only for PK testing.

- If the doctor thinks it is needed and you can become pregnant, part of the above blood
sample will be used for a pregnancy test.

If you are in Group 3, one (1) time between Day 29 of Cycle 2 and Day 1 of Cycle 3, you will
have a core tumor biopsy for biomarker and immune system testing.

Starting in Cycle 2 and then every even-numbered cycle after that (Cycles 4, 6, 8, and so
on), you will have an MRI or CT to check the status of the disease.

End-of-Study Visit:

Within 7 days after your last dose of study drug(s):

- You will have a physical exam.

- Blood (about 2 tablespoons) will be drawn for routine, transcriptonomics, and biomarker
tests.

- Depending when your last scan was performed, you may have an MRI or CT to check the
status of the disease.

Follow-up:

If you stopped taking the study drug(s) because the disease got worse, you will have
follow-up visits every 6 weeks for 100 days. If you stopped taking the study drug(s) for
reasons other than the disease getting worse, you will continue to have follow-up visits
every 6 weeks after Day 100. If the disease gets worse, you will stop having these visits.

At each visit:

- You will have a physical exam.

- Blood (about 2 tablespoons) will be drawn for routine and biomarker tests.

- If you stopped taking the study drug(s) for reasons other than the disease getting
worse, in addition to the above, you will have an MRI or CT to check the status of the
disease every 12 weeks. If the disease gets worse, you will stop having these scans.

Inclusion Criteria:

1. Patients must have biopsy-confirmed ovarian or other gynecologic cancers (fallopian
tube, peritoneal, endometrial, or cervical cancer) who have recurred after or
progressed on frontline and one or more second-line standard treatments. Patients with
ovarian/fallopian tube/peritoneal cancers must have platinum refractory or resistant
disease (defined as progression on a platinum containing regimen or recurrence within
180 days of prior dose of platinum-containing regimen) to be eligible for the
dose-finding phase. Enrollment for the expansion cohort will be limited to subjects
with high grade epithelial ovarian, fallopian tube, or peritoneal carcinomas who have
recurred after or progressed on frontline and one or more second-line standard
treatments. However, for the dose expansion phase, potential subjects are not required
to have platinum refractory or resistant disease.

2. Measureable metastatic disease (by RECIST v1.1) in the peritoneal cavity or
retroperitoneal lymph nodes. Disease outside of the peritoneal cavity is allowed as
long as metastatic sites are also present within the peritoneum/retroperitoneum.

3. Adequate renal, hepatic, bone marrow function. Including: a. absolute neutrophil count
>/=1500/mL; b. platelets >/= 100,000/mL; c. hemoglobin >/= 9 g/dL (transfusion to meet
this criterion is allowed); d. creatinine clearance >/= 50 mL/min (Using
Cockcroft-Gault); e. total bilirubin aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) X ULN (
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

5. Subjects must be >/= 18 years of age.

6. Subjects must be >/= 4 weeks beyond treatment with any chemotherapy or other
investigational therapy to include hormonal, biological, or targeted agents (>/= 8
weeks from previous bevacizumab treatment) at the time of first dose of study drug(s).

7. Women of child-bearing potential MUST have a negative serum human chorionic
gonadotropin (HCG) test unless prior hysterectomy or menopause (defined as 12
consecutive months of amenorrhea). Subjects are considered not to be of child-bearing
potential if they are surgically sterilized or post-menopausal (>/=50 years of age and
has not had menses for greater than 1 year or with serum FSH in the menopausal range
will be considered postmenopausal). Subjects should not become pregnant or breastfeed
while on this study. Sexually active subjects of child bearing potential must agree to
use contraception for the duration of study participation and for 5 months after the
last dose of ipilimumab or nivolumab.

8. Ability to understand and willingness to sign informed consent form prior to
initiation of the study and any study procedures.

9. Subjects in expansion cohort only: Willing to undergo pre- and on-treatment biopsies.

Exclusion Criteria:

1. Patients who are pregnant or breastfeeding

2. Patients with low grade ovarian/fallopian tube/peritoneal cancers

3. Prior immunotherapy with checkpoint inhibitors

4. History of inflammatory bowel disease (including ulcerative colitis and Crohn's
disease), or any other known autoimmune diseases including rheumatoid arthritis,
scleroderma, systemic lupus erythematosus, and autoimmune vasculitis.

5. History of previous malignancy that in the PI's opinion has a reasonable chance of
recurrence during the study period or otherwise confounding this clinical trial.

6. History of peritonitis or diverticulitis.

7. Patients requiring corticosteroids use at doses greater than prednisone 10 mg daily
equivalent (use of inhaled steroids, and short-term steroid for radiologic contrast
allergy, or treatment of immune-related adverse events are allowed).

8. Medical or surgical history that in the treating physician's opinion would make the
subject not a suitable candidate for i.p. therapy. Examples would include surgically
documented extensive intraperitoneal adhesions or large volume ascites.

9. History of COPD or other chronic pulmonary disease requiring systemic steroid therapy,
oxygen, or hospitalization.

10. Chronic hepatitis B or C virus infection, or known human immunodeficiency virus (HIV)
positive, that might affect host immunity.

11. Any other illness or condition that in the investigator's opinion would adversely
affect the safety of checkpoint inhibitor therapy.

12. Active infection requiring intravenous (IV) antibiotics or other uncontrolled
intercurrent illness requiring hospitalization.

13. Inability to comply with the study and follow-up procedures.

14. History of cerebrovascular accident, myocardial infarction or unstable angina within
the previous 6 months before starting therapy.

15. Prolongation of QT/QTc interval (QTc interval >470 ms) using the Fridericia method of
QTc analysis

16. Known active central nervous system metastases and/or carcinomatous meningitis.

17. History of severe hypersensitivity reaction with biologics therapy (monoclonal
antibodies).