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Nivolumab + Radiation Therapy for Oropharyngeal Cancer
Study Summary
This trial is testing a new combination of treatments for cancer in the back of the throat. The new combo will be compared to the current standard of care, which has serious side effects but is usually effective. The goal is to find a new combo that is just as effective but has fewer side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 25 Patients • NCT03122509Trial Design
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Who is running the clinical trial?
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- I am on steroids or other drugs that affect my immune system.My throat cancer is linked to HPV.I haven't had cancer treatment like chemotherapy or radiation in the last 30 days.I have not had radiation therapy above my collarbone.My cancer has not spread to distant parts of my body.I do not have any serious health issues that could make this study unsafe for me.I've seen a specialist for my heart or brain condition in the last 6 months.I have been cancer-free for at least two years, except for certain cancers.I am 18 years old or older.My diabetes, blood pressure, and any infections are under control.I have a new diagnosis of a specific throat cancer that can be surgically removed.I have an autoimmune disease, but it might be an exception.My kidney and liver functions are within normal ranges.I have been treated with drugs that target the immune system.I am fully active or restricted in physically strenuous activity but can do light work.My throat cancer is confirmed to be p16 positive.
- Group 1: Radiotherapy (RT) + Nivolumab Injection
- 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 there any positions available for participants in this experiment?
"The clinical trial in question is no longer actively recruiting patients, as the last update on trials.gov was over 3 months ago. That being said, there are still 3548 other ongoing trials that are looking for volunteers right now."
Do we have a history of using Radiotherapy (RT) for this purpose?
"As of right now, 747 clinical trials are being conducted that focus on radiotherapy (RT). Out of those 747 trials, 82 are currently in phase 3. Although a majority of the trials for RT are located in Basel, BE, 40325 different locations around the world are running studies for this treatment."
What are the most common indications for Radiotherapy (RT)?
"Radiotherapy is most often used to treat cancer, but it can also be useful for managing other conditions like unresectable melanoma or squamous cell carcinoma."
What are the aims of this research?
"According to the study's sponsor, Bristol-Myers Squibb, the primary outcome of this trial will be dependence on PEG tubes. This will be measured over a 3 year period from the beginning of treatment (post surgery). In addition to the primary outcome, other secondary outcomes being evaluated include Overall Survival (OS), which is defined as The length of time (in months) from the start of treatment patients remain alive., Adverse Events Related to Treatment, which is defined as Number of patients experiencing Adverse Events and Serious Adverse Events related to study treatment per Common Terminology Criteria for Adverse Events (CTCAE)"
How many people total will be participating in this experiment?
"Unfortunately, this particular clinical trial is no longer recruiting patients. The trial was originally posted on November 1st, 2018 but the most recent edit occurred on March 24th, 2022. However, there are still 2801 trials searching for carcinoma patients and 747 studies involving Radiotherapy (RT) that are currently enrolling participants."
What is the unique aspect of this clinical trial?
"Radiotherapy (RT) has been under investigation for about a decade. The first official trial was completed in 2010 by Medarex and, after being successful, led to Radiotherapy's Phase 1 drug approval. Now, there are over 700 active trials in more than 2300 cities across 50 nations."
Are there long-term risks associated with RT treatments?
"Radiotherapy (RT) has received a score of 2 because, while there is some evidence supporting its safety from Phase 2 trials, there is no data backing its efficacy."
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