Overview

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

Status:
Active, not recruiting
Trial end date:
2023-08-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ezra Cohen
Treatments:
Pembrolizumab
Vaccines
Criteria
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.

- Non-measurable disease by RECIST 1.1 and high-risk (>50% over 5 years) of mortality

- 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.