Summary

for people ages 18 years and up (full criteria)
at San Diego, California
study started
estimated completion:
Erza Cohen

Description

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.

Official Title

A Phase 1b Safety and Feasibility Study of Personalized Immunotherapy in Adults With Advanced Cancers

Details

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), and gastric cancer. Pembrolizumab is considered experimental (investigational) for the treatment of all other cancer types.

Keywords

Advanced Cancer immunotherapy personalized cancer vaccine personalized immunotherapy pembrolizumab Keytruda cancer Neoplasms Vaccines personalized vaccine vaccine and anti-PD-1 anti-PD1 before vaccine

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.
  • Patient has 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.
  • HIV seropositive patients

You CAN'T join if...

  • Patient is currently receiving or has received another anti-cancer therapy within 2 weeks prior to first dose of vaccinestudy treatment.
  • Patient is currently receiving or has received PD1/PDL1 inhibitor immunotherapy within 4 weeks prior to first dose of study treatment.
  • Patient is 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
  • Known or suspected allergy or hypersensitivity to any component of vaccine.
  • Received a diagnosis of acquired immune deficiency syndrome (AIDS).
  • 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.
  • 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.

Location

  • UCSD Medical Center accepting new patients
    San Diego California 92103 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ezra Cohen
ID
NCT03568058
Phase
Phase 1
Lead Scientist
Erza Cohen
Study Type
Interventional
Last Updated
September 10, 2018