Personalized Immunotherapy in Adults With Upper Gastrointestinal Tract Cancers

NCT05153304 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: PCV-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer of Gastrointestinal Tract

Keywords

cancer; gastrointestinal; immunotherapy; personalized cancer vaccine; nivolumab; neoantigen; vaccine

Outcome Measures

Primary Outcomes (2)

• Quantitative frequency of TCR

  1 year

• Treatment-related Adverse Events

  1 year

Secondary Outcomes (4)

• Progression-free survival (PFS)

  1 year

• Overall Survival

  1 year

• Overall Response

  1 year

• Duration of response

  1 year

Study Arms (1)

anti-PD1 and personalized vaccine

EXPERIMENTAL

Biological: personalized vaccine; Drug: Nivolumab

Interventions

personalized vaccine BIOLOGICAL

Vaccine will be constructed for each subject that express multiple candidate tumor-derived neoantigens.

anti-PD1 and personalized vaccine

Nivolumab DRUG

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.

Also known as: Opdivo

anti-PD1 and personalized vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ezra Cohen, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

US (1)