What is the purpose of this study?
The PROCEADE CRC-03 Study is a Phase 3 clinical study of an investigational medicine for adults with previously treated metastatic colorectal cancer. In Phase 3, the goal is to confirm earlier findings of safety and efficacy in a larger group of people so doctors and regulators can understand the investigational medicine more clearly.
What makes the study medicine investigational?
The investigational medicine can only be given to participants in a clinical study. It is not approved for treating metastatic colorectal cancer in any country.
What are the possible benefits for me?
Your study treatment may or may not affect your cancer, and we cannot predict how it will work for any individual. You will receive regular check-ins and careful monitoring throughout the study. Even if the study treatment doesn’t help you directly, your involvement may guide new discoveries for others in the future.
What are the possible side effects or downsides?
As with any medicine, there is the possibility of side effects. Talk to the study doctor about anything that bothers you so that together you can decide on the best course of action. Your study treatment may or may not affect your cancer, and we cannot predict how it will work for any individual.
How often will I have scans?
Tumor scans will be done every 6 weeks after the start of the first study treatment cycle. After the 7th scan, scans will be done every 12 weeks.
How long will I be in the study?
The study does not have a defined length of time. Study treatment will continue as long as it is safe and helpful for you and you agree to continue. After you stop the study treatment, the study staff will continue to follow up with you by phone to see how you are doing.
Will I still see my regular doctor?
Yes. You can continue seeing your regular doctors while you take part in the study. The study doctor will manage your study-related treatment and tests.
Can I choose which study treatment I get?
No. The study uses randomization, which means a computer assigns treatments by chance to make sure the results are fair and unbiased.
Are there costs to me, and what is covered by the study?
Participants will not be charged for participating in the study. If eligible, you and a caregiver may be reimbursed for expenses related to participation, such as transportation, accommodation, and meals.
What happens if my condition gets worse?
Your health will be monitored closely throughout the study. You and your doctor will work together to determine whether stopping the study is in your best interest. Reasons for stopping may include cancer progression, intolerable side effects, or other medical reasons. If you need to stop the study, the study doctor will discuss other options with you.
Can I leave the study at any time?
Yes. Participation in a clinical study is voluntary, and you can leave at any time. If you wish to leave, tell the study staff. You may be asked to come for a final visit so that you can exit the study safely.
How will my privacy and health information be protected?
Your privacy is protected through strict rules, coded data instead of names, limited access, encrypted storage, and careful procedures that ensure only essential information is shared.
What support is available if I have questions or concerns?
You will have a dedicated healthcare team for the entire study. If you have any questions or concerns, contact your study doctor.
What happens after I leave the study?
After you have stopped taking your study treatment, the study staff will continue to follow up with you by phone about every 3 months to see how you are doing.