General Study Questions
How long will I be in the study?
You will receive study treatment for 12 months and may be in the study for up to a total of 5 years.
How frequently will I have to go to the study site?
During the Study Treatment Period, you will visit the study site to receive an infusion and have tests every 3 weeks for the first 3 months, then every 6 weeks for the remaining 9 months. During the Follow-up Period, you will have visits 30 days and 90 days after finishing the study treatment and every 3 to 6 months thereafter.
How much time will I spend at the clinic for study visits?
For each study visit, you may be at the clinic for 2 to 3 hours or for half a day, depending on the tests being done. Ask the study team before your next visit so that you can plan ahead.
What are the benefits of participating in the study?
Your health will be monitored continuously throughout the study. Even if you do not directly benefit from participating in the study, any information collected may help researchers learn more about the study drug and about treating other adults with head and neck cancer in the future.
Will it cost me anything to be in the study?
You will receive the study treatment (study drug or placebo) and all study-related tests at no cost to you.
Who is sponsoring the study?
The global biopharma company GlaxoSmithKline is sponsoring the study. They pay the study doctor and study site to run this study.
What if I decide to join the study and then change my mind?
Participation in the study is voluntary. If you decide to join and then change your mind, you can leave the study at any time. Leaving the study will not affect your regular medical care.
Study Treatment Questions
Which study treatment will I receive?
You will be randomly assigned to receive either the study drug or placebo. The placebo looks like the study drug but does not contain active medicine. This gives researchers something to compare with the study drug to better understand its effects. Neither you nor the study doctor will know which the group to you are assigned. This helps to keep the study results unbiased.
How is the study drug (or placebo) given?
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, for a total of 12 months.
How does the study drug work?
Dostarlimab is a type of drug that helps your immune system fight cancer. This type of treatment is called immunotherapy.
Are there any side effects from the study drug?
As with all medicines, there is the possibility of side effects, which are unwanted or unintended effects of a medicine. Talk to the study doctor for more information on possible side effects. Your health will be closely monitored throughout the entire study. Tell the study doctor if you notice any side effects or changes in your health.