Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05153304
Recruitment Status : Not yet recruiting
First Posted : December 10, 2021
Last Update Posted : December 10, 2021
Sponsor:
Information provided by (Responsible Party):
Ezra Cohen, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Cancer of Gastrointestinal Tract Biological: personalized vaccine Drug: Ipilimumab Drug: Nivolumab Phase 1 Phase 2

Detailed 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 and ipilimumab. 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. Ipilimumab is a drug that helps to activate the body's immune response against 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, ipilimumab, and the personalized cancer vaccine is experimental and is not FDA approved.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Personalized Immunotherapy in Adults With Upper Gastrointestinal Tract Cancers
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
Experimental: anti-PD1, anti-CTLA4, and personalized vaccine Biological: personalized vaccine
Vaccine will be constructed for each subject that express multiple candidate tumor-derived neoantigens.

Drug: Ipilimumab
1 mg/kg ipilimumab will be administered intravenous (IV) infusion every 3 weeks for 4 doses.
Other Name: Yervoy

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.
Other Name: Opdivo




Primary Outcome Measures :
  1. Quantitative frequency of TCR [ Time Frame: 1 year ]
  2. Treatment-related Adverse Events [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 1 year ]
  2. Overall Survival [ Time Frame: 1 year ]
  3. Overall Response [ Time Frame: 1 year ]
  4. Duration of response [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically documented gastroespohageal or gastric ademocarcinoma.
  • 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 CTLA4 or 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05153304


Contacts
Layout table for location contacts
Contact: Shakeela Dad (858) 822-6100 sdad@health.ucsd.edu
Contact: Aaron Miller ammiller@health.ucsd.edu

Locations
Layout table for location information
United States, California
University of California, San Diego
La Jolla, California, United States, 92037
Sponsors and Collaborators
Ezra Cohen
Investigators
Layout table for investigator information
Principal Investigator: Ezra Cohen, MD University of California, San Diego
Layout table for additonal information
Responsible Party: Ezra Cohen, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT05153304    
Other Study ID Numbers: PCV-001
First Posted: December 10, 2021    Key Record Dates
Last Update Posted: December 10, 2021
Last Verified: November 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ezra Cohen, University of California, San Diego:
cancer
gastrointestinal
immunotherapy
personalized cancer vaccine
nivolumab
ipilimumab
neoantigen
vaccine
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action