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.