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Immunotherapy + Radiation for Gastroesophageal Cancer (REACTION Trial)
REACTION Trial Summary
This trial is testing if it's safe to use immunotherapy after SBRT in people with recurrent or metastatic gastroesophageal cancer.
REACTION Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowREACTION Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT02041533REACTION Trial Design
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Who is running the clinical trial?
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- My heart's pumping ability is normal, confirmed by a heart test within the last 6 months.I have never had myocarditis.I am 18 years old or older.I agree to use birth control during and after the study as required.My cancer has returned or is in stage IV, and I chose not to have chemotherapy as the first treatment.I agree to use contraception during and after treatment as required.I agree not to donate sperm during the trial.My heart markers are within acceptable limits for the Relatlimab arm.I do not have brain metastasis.I do not have significant heart problems or recent serious heart events.I can provide a sample of my tumor for testing.I am fully active or can carry out light work.My organs are functioning well.I had cancer before, but it's been in complete remission for over 2 years, and I don't need treatment now.I have a history of lung disease but don't need constant oxygen.I am currently being treated for an infection or have tested positive for Hepatitis B or C.I am 18 years old or older.I agree to use contraception and not donate sperm during and after the study as required.I understand the study, its risks, and am willing to follow its requirements.I understand the study, its risks, and I'm willing to sign the consent form.I do not have an active autoimmune disease or a history that required immune-suppressing drugs, except for vitiligo or resolved childhood asthma.I agree to use birth control during and after the study as required.My heart's electrical activity is normal according to my last ECG.I have tested positive for HIV/AIDS.I can provide a sample of my tumor for testing.My cancer has come back or is stage IV, and I chose not to have chemotherapy as the first treatment.I haven't had any vaccines in the last 4 weeks.My cancer in the esophagus or stomach has been confirmed by a biopsy.I need to take corticosteroids through pills or injections, but I can use inhalers.I am not pregnant or nursing.My female partner and I are not willing to use birth control.My heart's electrical activity is normal according to my last ECG.
- Group 1: Arm A Nivolumab Only
- Group 2: Arm B Nivolumab + Relatlimab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are people of any age eligible for this trial?
"According to the rules set for this experiment, anyone aged 18-99 is allowed to participate."
Are we currently enrolling new participants for this research project?
"That is correct. As detailed on clinicaltrials.gov, this research is currently looking for subjects. The trial was originally posted on March 6th, 2019 and was updated as recently as May 5th, 2022. They are hoping to find 21 individuals total from 3 different locations."
Has this research been published before?
"Nivolumab has been under medical scrutiny since 2010 when the first study, sponsored by Medarex, was completed. After 127 people participated in the initial experiment, Nivolumab received Phase 1 drug approval in 2010. As of now, there are 749 active trials for Nivolumab taking place across 2348 cities and 50 countries worldwide."
For what purpose is Nivolumab most commonly prescribed?
"Nivolumab is a medication that oncologists often prescribe to their patients with malignant neoplasms. Additionally, this drug can be given to people suffering from other conditions such as unresectable melanoma or squamous cell carcinoma."
Is Nivolumab a relatively new medication?
"749 studies that involve Nivolumab are currently active. Of those, 82 have reached Phase 3 of clinical trials. The many studies for Nivolumab originate in Basel, BE; however, 40408 locations around the world are running these tests."
How many individuals are being monitored for this experiment?
"That is correct, the clinicaltrials.gov website shows that this study is still open to participants. The listing was created on March 6th, 2019 and updated as recently as May 5th, 20212. So far, 21 patients have been enrolled at 3 different sites."
Who is eligible for participating in this scientific research?
"The recruitment drive for this clinical trial aims to enroll 21 individuals that currently have cancer. The age limit is set at 18 years old and participants must be below 99 years old. There are several other requirements: being male or female, having an ECOG performance status of 0-1, and having recurrent disease or Stage IV disease as per American Joint Committee on Cancer (AJCC) staging 8.0 - patients who decline systemic chemotherapy in the first line metastatic setting are eligible.."
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