What is a clinical study?
Clinical studies are research studies that help doctors and scientists learn more about a disease or medical condition and new ways to treat, diagnose, or prevent it. They are also called clinical trials. To learn more about clinical studies, watch the videos below.
Understanding Clinical
Trials
Understanding Informed Consent and e-Consent
What is the JADE Study?
This study is being done to learn more about the study drug, dostarlimab, in adults with locally advanced, unresected head and neck cancer. Dostarlimab is a type of drug that helps your immune system fight cancer (immunotherapy). Researchers want to see if dostarlimab, when used after chemotherapy + radiation, can lower the risk of the cancer returning or worsening.
Who can participate?
You may qualify for this study if you meet the following criteria. Additional participation criteria also apply.
Age
18 years of age or older
Diagnosis
Locally advanced head and neck cancer of the mouth or throat
Cancer characteristics
Has not spread to distant parts of the body
Treatment
- Completed chemotherapy + radiation
- Cancer has not been removed by surgery
What happens
during the study?
You will first need to give your consent, or permission, to join the study by reading and signing the Informed Consent Form.
1. Pre-Screening
(optional)
Before you receive chemotherapy and radiation, the study doctor will discuss the study with you if you are interested. You may also have a single blood sample taken.
2. Screening
(up to 28 days)
To see if you qualify for the study, the study team will ask questions about your health and the medicines you take and will run some tests. (This step is required after completing chemotherapy + radiation, even if you were prescreened.)
3. Study Treatment
(12 months; about 11 visits)
You will be randomly assigned to receive either:
- The study drug (dostarlimab)
or - Placebo.*
*The placebo looks just like the study drug but does not contain active medicine. It’s important to give researchers something to compare with the study drug to better understand its effects.
Neither you nor the study doctor will know which treatment you are receiving. This helps to keep the study unbiased.
You’re just as likely to be assigned to the study drug group as to the placebo group.
The study drug (or placebo) is given as an intravenous (IV) infusion, which means it is given through a vein in the arm over the course of 30 minutes. You will receive an infusion every 3 weeks for the first 3 months, then every 6 weeks for the remaining 9 months.
At these visits you will also have tests to check on your health and to see how your cancer is responding to treatment.
4. Follow-up
(up to 4 years)
You will have visits 30 days and 90 days after finishing the Study Treatment Period. You will then have visits every 3 to 6 months for up to 4 years to check on your health and to have scans to see if your cancer returns over a longer period of time. If your cancer returns, the study team will call you every 6 months to check on your health.
What kinds of tests and health checks can I expect?
Some of the tests you may have during the study are shown below. You will not have all of these tests at every visit. Talk to the study doctor to learn more.
Physical exam
Vital signs
Heart activity
Heart imaging
Blood tests
Urine test
Imaging tests*
Questionnaires
Endoscopy (fibroscopy; if needed)
Surgery (if needed)
*Imaging tests may include MRI, CT scan, PET scan, or bone scan. CT = computed tomography; MRI = magnetic resonance imaging; PET = positron emission tomography.