Personalized Immunotherapy in Adults With Upper Gastrointestinal Tract Cancers

Cancer of Gastrointestinal Tract Clinical Trial

Official title:

A Phase I/II Study of Personalized Immunotherapy in Adults With Upper Gastrointestinal Tract Cancers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05153304
• Other study ID #: PCV-001
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: June 2024
• Est. completion date: June 2027

Study information

• Verified date: June 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if it is possible to make and safely administer a 'personalized' cancer vaccine for people diagnosed with an upper gastrointestinal tract cancer.

Description:

The purpose of this study is to determine if it is possible to make and safely administer a 'personalized' cancer vaccine for people diagnosed with an upper gastrointestinal tract cancer.

It is known that cancer has mutations (changes in genetic material) that are specific to an individual person and their tumor. These mutations can cause the tumor cells to produce proteins that are different from the body's normal, healthy cells. The study will use a sample of your tumor to create a vaccine against it, with the idea being that the study vaccine will "teach" the body's immune system to recognize and attack the cancer cells. The study will examine the safety of the study vaccine when given at several time points and will examine your blood for signs that the study vaccine causes the immune system to respond.

The personalized cancer vaccine will be given alone or in combination with nivolumab. Nivolumab is a drug that blocks certain proteins on cells that help to keep immune responses in check. In a healthy person, this keeps the immune system from attacking healthy cells and tissues, but cancer cells use these proteins to keep the immune system from killing cancer cells and tumors. When these proteins are blocked, the check on the immune system is removed and immune cells may be able to recognize and kill cancer cells.

This personalized cancer vaccine is considered experimental because it is not approved by the US Food & Drug Administration (FDA) as a treatment for cancer.

The combination of nivolumab and the personalized cancer vaccine is experimental and is not FDA approved.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically documented gastroespohageal or gastric adenocarcinoma.

• Measurable disease as defined by RECIST 1.1

• 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)

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.

• 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.

Related Conditions & MeSH terms

• Cancer of Gastrointestinal Tract
• Gastrointestinal Neoplasms

Intervention

Biological:
• personalized vaccine
Vaccine will be constructed for each subject that express multiple candidate tumor-derived neoantigens.

Drug:
• Nivolumab
3mg/kg nivolumab will be administered intravenous (IV) infusion every 3 weeks for 4 doses. After 4 doses, 480 mg nivolumab will be administered intravenous (IV) infusion every 4 weeks.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative frequency of TCR		1 year
Primary	Treatment-related Adverse Events		1 year
Secondary	Progression-free survival (PFS)		1 year
Secondary	Overall Survival		1 year
Secondary	Overall Response		1 year
Secondary	Duration of response		1 year