Personalized Immunotherapy in Adults With Advanced Cancers Immunotherapy in Adults With Advanced Cancers

The purpose of this study is to determine if it is possible to make and administer safely a
'personalized' vaccine to treat patients that have been diagnosed with advanced cancer and
are not candidates for curative therapy.

This 'personalized' vaccine will use information gained from specific characteristics of your
own cancer. It is known that cancer has mutations (changes in genetic material) that are
specific to an individual and tumor. These mutations can cause the tumor cells to produce
proteins that appear very different from the body's own cells. It is possible that these
proteins used in a vaccine may induce strong immune (protective) responses, which may help
your body fight any tumor cells that could cause your cancer to come back in the future. The
study will examine the safety of the vaccine when given at several time points and will
examine your blood cells for signs that the vaccine induced an immune response.

The personalized vaccine will be given in combination with an anti-PD1 antibody,
pembrolizumab, which is used with the intention to increase anti-cancer immunity
(protection). Pembrolizumab is a type of drug that blocks certain proteins made by some types
of immune system cells, such as T cells, and some cancer cells. These proteins help keep
immune responses in check and can keep T cells from killing cancer cells. When these proteins
are blocked, the "brakes" on the immune system are released and T cells are able to kill
cancer cells better.

This personalized vaccine is considered experimental because this is not an FDA approved
therapy for cancer.

Pembrolizumab is FDA approved for the treatment of melanoma, non-small cell lung cancer
(NSCLC), head and neck squamous cell carcinoma (HNSCC), classical Hodgkin lymphoma (cHL),
urothelial carcinoma, microsatellite instability-high cancer (MSI-H), gastric cancer,
cervical cancer, and hepatocellular carcinoma (HCC). Pembrolizumab is considered experimental
(investigational) for the treatment of all other cancer types.

Inclusion Criteria

- Histologically or cytologically documented incurable solid tumor [excluding lymphoma].

- Measurable disease as defined by RECIST 1.1

- Progressed on or be intolerant to therapies that are known to provide clinical
benefit.

- At least one tumor site accessible for biopsy.

- Adequate organ function

- Women of child-bearing potential and men with partners of child-bearing potential must
agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry, for the duration of study participation, and for 90
days following completion of therapy.

Exclusion Criteria

- Currently receiving or has received another anti-cancer therapy within 4 weeks prior
to first dose of vaccine study treatment.

- Currently receiving or has received PD1/PDL1 inhibitor immunotherapy within 4 weeks
prior to first dose of study treatment.

- Currently receiving or has received anti-PD1 or anti-CTLA4 treatment during the
vaccine preparation period.

- Receiving TNF pathway inhibitors, PI3 kinase inhibitors, systemic steroid therapy or
any other form of immunosuppressive therapy within 14 days prior to the first dose of
study medication.

- Received an investigational agent within 28 days prior to the first dose of study
drug.

- Untreated brain metastases; individuals with treated and stable metastases are
eligible. Eligible subjects should have recovered from the acute effects of radiation
therapy or surgery prior to study entry, have discontinued corticosteroid treatment
for brain metastases for at least 4 weeks and are neurologically stable for 8 weeks
(confirmed by MRI) prior to administration of experimental therapy

- Has known history of Human Immunodeficiency Virus (HIV).

- Received a diagnosis of hepatitis B or hepatitis C for which there is no clear
evidence of natural immunity, immunity subsequent to vaccination, or successful
eradication of the virus following antiviral therapy (individuals who are hepatitis C
antibody positive may be enrolled if negative viral load confirmed).

- History of autoimmune disease including: inflammatory bowel disease (including
ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive
sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis (e.g.
Wegener's granulomatosis); central nervous system or motor neuropathy considered of
autoimmune origin (e.g. Guillain-Barré syndrome, myasthenia gravis, multiple
sclerosis). Individuals with vitiligo, Sjogren's Syndrome, interstitial cystitis,
Graves' or Hashimoto's Disease, celiac disease, DM1, or hypothyroidism stable on
hormone replacement will be allowed with Study Medical Monitor's approval.

- Has a history of (non-infectious) pneumonitis that required steroids or has current
pneumonitis.

- History of receiving a solid organ transplant or allogeneic bone marrow transplant.

- Major surgical procedure within 28 days prior to the first dose of study drug.

- If female, pregnant or breastfeeding.