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Checkpoint Inhibitor

Nivolumab + Radiation for Gastroesophageal Cancer

Phase 2
Waitlist Available
Led By Manish Shah, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years
Subjects with a diagnosis of advanced unresectable or metastatic gastroesophageal adenocarcinoma (eg. gastric, gastroesophageal junction, and esophageal adenocarcinoma)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights

Study Summary

This trial is testing if nivolumab alone or with radiation therapy can help people with cancer who didn't respond to initial treatment with FOLFOX and nivolumab.

Who is the study for?
Adults over 18 with advanced gastroesophageal adenocarcinoma that can't be surgically removed or has spread, who haven't progressed after initial FOLFOX and Nivolumab therapy. Participants need normal organ function, not pregnant, willing to use birth control, and able to provide a recent tumor tissue sample. Excludes those with immune deficiencies, active infections or other cancers within the last 3 years (with some exceptions), autoimmune diseases requiring treatment in the past 2 years, known HIV/Hepatitis B/C, or prior anti-PD-1/L1/L2 therapies.Check my eligibility
What is being tested?
This phase II trial is testing whether adding radiation therapy to nivolumab offers any benefit compared to nivolumab alone for patients whose cancer hasn't worsened following initial treatment with FOLFOX chemotherapy combined with nivolumab.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation of organs like lungs or intestines; skin reactions; liver problems; hormonal gland issues like thyroid dysfunction; fatigue; infusion reactions and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I have advanced cancer that started in my stomach or esophagus and it can't be removed by surgery.
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I agree to provide a recent biopsy sample of my tumor.
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I agree to use birth control and, if I'm a woman who can have children, I have a recent negative pregnancy test.
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My kidney function is normal or near normal.
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I am fully active and can carry on all pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Number of patients with 12-month progression free survival
Secondary outcome measures
Number of subjects who receive short course chemotherapy with immunotherapy that achieve 12-month progression free survival
Occurrence of Significant Toxicity, as measured by Number of Grade 3 and Grade 4 Adverse Events (Combined) Attributable to Immunotherapy
Overall Survival, as measured by the rate of survival in patients

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2. Subjects in Cohort 2 will receive Nivolumab (every 2 weeks for two doses, and then every 4 weeks) plus radiation therapy (total 5 sessions)
Group II: Cohort 1Experimental Treatment1 Intervention
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2. Subjects in Cohort 1 will receive Nivolumab alone (every 2 weeks for two doses, and then every 4 weeks)

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,052 Previous Clinical Trials
1,329,792 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,456 Total Patients Enrolled
Manish Shah, MDPrincipal InvestigatorWeill Medical College of Cornell University
6 Previous Clinical Trials
327 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04021108 — Phase 2
Gastroesophageal Adenocarcinoma Research Study Groups: Cohort 1, Cohort 2
Gastroesophageal Adenocarcinoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04021108 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04021108 — Phase 2

Frequently Asked Questions

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

How many medical facilities in the US are currently executing this experiment?

"Patients are being recruited from five different medical centres, spread among Omaha, New york and Tampa as well as two other cities. It is recommended that you select the closest site to reduce travel needs in case of enrolment."

Answered by AI

Does this research represent a pioneering effort in its field?

"Nivolumab 240 MG has been subject to research since 2012, with Ono Pharmaceutical Co. Ltd. leading the inaugural trial involving 659 participants. After completing Phase 1 & 2 trials successfully, this drug is now being actively studied in 718 studies across 2354 cities and 49 nations worldwide."

Answered by AI

Are there any vacancies available in this medical experiment?

"Affirmative. Clinicaltrials.gov states that the trial, initiated on July 22nd 2019, is actively seeking participants and has recently been updated as of June 29th 2022. 74 volunteers are sought from 5 distinct clinical sites."

Answered by AI

How many participants are partaking in this experiment?

"The study necessitates the inclusion of 74 qualified participants, who can apply from either University of Nebraska in Omaha or Weill Cornell Medicine in New york."

Answered by AI

Has there been any prior research into the efficacy of Nivolumab 240 MG?

"Nivolumab 240 MG was initially trialed in 2012 at a Local Institution, currently there are 250 completed trials and 718 ongoing studies. Notably, many of the recruiting sites for these clinical trials can be found in Omaha, Nebraska."

Answered by AI

What diseases are typically addressed with an injection of Nivolumab 240 MG?

"Nivolumab 240 MG is commonly used to battle malignant neoplasms and can also be applied in the treatment of conditions like metastatic esophageal adenocarcinoma, squamous cell carcinoma, or unresectable melanoma."

Answered by AI

Has the US Food and Drug Administration sanctioned Nivolumab 240 MG?

"The safety of Nivolumab 240 MG was assigned a score of 2, as Phase 2 trials have only provided evidence to support its security rather than efficacy."

Answered by AI
~14 spots leftby Apr 2025