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Cancer Vaccine + Entinostat + Nivolumab for Esophageal Cancer
Phase 1 & 2
Recruiting
Led By David S Schrump, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 2 weeks prior to initiation of treatment, prior to 1st vaccine, one month following the first six vaccinations (start of cycle 7), and every 6 months (24 weeks) during treatment continuation
Awards & highlights
Study Summary
This trial evaluates safety and immune response of a vaccine to treat locally advanced esophageal cancer. Phase I will determine safe dose, and Phase II will assess level of immune response.
Who is the study for?
This trial is for adults over 18 with Stage II or III esophageal cancer who have undergone chemoradiation therapy, possibly with surgery, and may still have disease present. They should not have had prior anti-PD1/anti-PD-L1 therapy, must be in good physical condition (ECOG 0-1), and able to start treatment within 16 weeks after their last cancer therapy. Participants need proper organ function and cannot be pregnant or breastfeeding. They must agree to use contraception and co-enroll in a related genetic study.Check my eligibility
What is being tested?
The trial tests the safety and immune response of an H1299 cell lysate vaccine mixed with Montanide(R) ISA-51 VG adjuvant alongside Entinostat and Nivolumab as additional treatments post-chemoradiation for esophageal cancer. Phase I determines the safe dose of the vaccine combo, while Phase II assesses immune responses at that dose level.See study design
What are the potential side effects?
Potential side effects include typical reactions to vaccines such as soreness at injection site, fever, fatigue; possible inflammation from Nivolumab; plus any common drug-related risks like nausea or liver enzyme changes due to Entinostat.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 2 weeks prior to initiation of treatment, prior to 1st vaccination, 1 month following first 6 vaccinations, and every 6 months (24 weeks) during treatment continuation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 2 weeks prior to initiation of treatment, prior to 1st vaccination, 1 month following first 6 vaccinations, and every 6 months (24 weeks) during treatment continuation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I Component: To determine the safe dose of adjuvant H1299 lung cancer cell lysate vaccines with Montanide(R) ISA-51 VG administered in conjunction with entinostat and nivolumab in participants with locally advanced esophageal cancers (EsC)...
Phase II Component: To assess the frequency of immunologic responses to purified cancer-testis (CT) antigens in EsC participants receiving adjuvant vaccinations with H1299 cell lysate/Montanide(R) ISA-51 VG in combination with entinostat and niv...
Secondary outcome measures
Phase I + II Component: To assess safety of adjuvant H1299 lung cancer cell lysate vaccines with Montanide(R) ISA-51 VG administered in conjunction with entinostat and nivolumab in participants with locally advanced esophageal cancers (EsC) with...
Phase I Component: To assess the frequency of immunologic responses to purified cancer-testis (CT) antigens in EsC participants receiving adjuvant vaccinations with H1299 cell lysate/Montanide(R) ISA-51 VG in combination with entinostat and nivo...
Phase II Component: To determine progression free survival (PFS) in EsC participants receiving the investigational adjuvant vaccine regimen
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2/ Phase IIExperimental Treatment4 Interventions
H1299 cell lysate vaccine with Montanide(R) ISA-51 VG, entinostat, and nivolumab (lysate at dose determined in Phase I)
Group II: 1/ Phase IExperimental Treatment4 Interventions
H1299 cell lysate vaccine with Montanide(R) ISA-51 VG, entinostat, and nivolumab (Phase I component to determine lysate dose)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Entinostat
2017
Completed Phase 2
~1170
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,752 Total Patients Enrolled
David S Schrump, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
2,174 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My esophageal cancer is Stage II or III and may still be present after treatment.I completed my chemo or chemo and surgery within the last 16 weeks.My blood, liver, and kidney tests are within normal ranges.I do not have uncontrolled high blood pressure or recent heart issues.I am on long-term steroids in doses higher than the body's normal levels.My lung function is above the minimum required levels.I have no other cancer needing treatment except for skin cancer that hasn't spread.I haven't had a serious illness in the last 3 months.I have not received anti-PD1 or anti-PD-L1 therapy for esophageal cancer.I am 18 years old or older.I am fully active or can carry out light work.I am on warfarin and cannot switch to another blood thinner.I can understand and agree to the study's terms.
Research Study Groups:
This trial has the following groups:- Group 1: 2/ Phase II
- Group 2: 1/ Phase I
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are geriatric patients eligible for this research trial?
"This medical study is open to any patient who has attained the age of majority and whose chronological years have not exceeded 120."
Answered by AI
What qualifications do participants need to fulfill in order to partake in this research?
"Eligibility criteria for this medical trial requires that applicants must have tumors and be between 18 to 120 years old. The study is seeking a total of 50 participants."
Answered by AI
Are there any open enrollment opportunities for this research endeavor?
"According to clinicaltrials.gov, this research initiative is no longer recruiting participants after being posted on June 15th 2023 and updated most recently on June 9th of the same year. However, there are still 2781 other trials which require volunteers at this moment in time."
Answered by AI
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