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Checkpoint Inhibitor

Personalized Immunotherapy for Gastrointestinal Cancer

Phase 1 & 2

Waitlist Available

Led By Ezra Cohen, MD

Research Sponsored by Ezra Cohen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically documented gastroespohageal or gastric adenocarcinoma

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will test if a cancer vaccine can be made and safely given to people with upper gastrointestinal tract cancer.

Who is the study for?

Adults with confirmed upper gastrointestinal tract cancer who can have a personalized vaccine and Nivolumab. They must be able to get pregnant or have partners who can, and agree to use birth control. Participants need measurable disease by certain medical criteria and good organ function. People with recent other cancer treatments, serious lung conditions, organ transplants, untreated brain metastases, HIV, hepatitis without immunity or eradication, major surgery within the last month, pregnancy/breastfeeding or certain autoimmune diseases are excluded.Check my eligibility

What is being tested?

The trial is testing whether a 'personalized' cancer vaccine alongside Nivolumab is safe for patients with upper gastrointestinal cancers. The study aims to tailor the treatment based on individual characteristics of each participant's tumor in order to boost their immune system against the cancer.See study design

What are the potential side effects?

Potential side effects may include typical reactions related to vaccines such as soreness at injection site or fever and those associated with immunotherapy like Nivolumab which could involve flu-like symptoms, fatigue, skin reactions or more severe immune-related effects impacting organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer is confirmed to be in the stomach or esophagus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Quantitative frequency of TCR

Treatment-related Adverse Events

Secondary outcome measures

Duration of response

Overall Response

Overall Survival

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: anti-PD1 and personalized vaccineExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ezra CohenLead Sponsor

4 Previous Clinical Trials

73 Total Patients Enrolled

Ezra Cohen, MDPrincipal InvestigatorUniversity of California, San Diego

13 Previous Clinical Trials

763 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05153304 — Phase 1 & 2

Gastrointestinal Cancer Research Study Groups: anti-PD1 and personalized vaccine

Gastrointestinal Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT05153304 — Phase 1 & 2

Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05153304 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are personalized vaccines used to target?

"The personalized vaccine is a medical intervention that has been traditionally used to treat patients that have undergone anti-angiogenic therapy. Additionally, this treatment can be effective for those suffering from malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

How many test subjects are there in this experiment?

"This trial is not currently looking for patients. The posting date was June 1st, 2022 and the last edit was on November 29th, 2021. However, there are 796 other trials related to personalized vaccines and 148 trials concerning gastrointestinal neoplasms that are still recruiting patients."

Answered by AI

What other research has been done on vaccines that are specific to an individual's needs?

"As of right now, there are 796 different clinical trials studying personalized vaccines. Out of those, 86 have progressed to phase 3 testing. The majority of these studies originate from Pittsburgh, but there are 43000 other locations conducting similar research."

Answered by AI

Are patients being sought for this experimental procedure?

"This trial is no longer enrolling patients. The study was first posted on 6/1/2022 and last updated on 11/29/2021. If you are seeking other studies, there are presently 148 trials actively admitting participants with gastrointestinal neoplasms and 796 personalized vaccine studies actively searching for patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Personalized Immunotherapy in Adults With Upper Gastrointestinal Tract Cancers

Ezra Cohen 2023. "Personalized Immunotherapy in Adults With Upper Gastrointestinal Tract Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05153304.

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