General Study Questions
What are the benefits of participating in a clinical 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 colon or rectal cancer in the future.
Will it cost me anything to be in the study?
You will receive the study treatment (study drug or standard treatment) and all study-related tests at no cost to you.
Who is sponsoring the study?
The global biopharma company GSK is sponsoring the study. GSK pays 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.
Screening Question
What does dMMR/MSI-H mean?
As cells multiply, copies of their DNA are made. During this process, mistakes can happen in the DNA. The body normally corrects these mistakes with different repair systems such as MMR (mismatch repair). Cells with deficient mismatch repair (dMMR) have a high number of specific mutations, or changes, in their DNA (MSI-H). The presence of dMMR/MSI-H can help determine treatment options for people with colon or rectal cancer. dMMR/MSI-H tumors have been found to respond to immunotherapy.
Study Treatment Questions
What is standard treatment for colorectal cancer that has not spread?
Colon cancer or rectal cancer that has not spread to other parts of the body is typically treated by removing the cancer with surgery. After surgery, chemotherapy may be given, or the person may be closely monitored for signs of cancer returning.
How is the study medicine given?
The study medicine is given by intravenous (IV) infusion every 3 weeks. An IV infusion means the medicine is given slowly through a needle into a vein in your arm.
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.