Learn About Our New Clinical Trial
Gritstone bio Inc., in collaboration with Worldwide Clinical Trials, is conducting a clinical trial of GRT C901/GRT-R902 (an investigational personalized vaccine) plus immunotherapy in patients with Advanced Stage IV Colorectal Cancer.
Why is this study being done?
The main purpose of this research study is to find out how effective the personalized vaccine, GRT- C901/GRT-R902, is in treating patients with advanced colorectal cancer (CRC) when used together with immunotherapy that activates the immune system and standard of care chemotherapy.
Previous trials with GRT-C901/GRT-R902
There have been no completed trials using GRT-C901/GRT-R902. However, an ongoing study has treated 26 patients with cancer (including 12 with CRC) and the study doctor can tell you more about what to expect for side effects.
How do I know if I can be in the study?
Before you start, you will be given an informed consent form to review. The consent form will provide you with additional details about the study. You will have the opportunity to ask the study doctor any questions you have and discuss participation with your family.
If you decide to sign the informed consent form, you will need to have tests performed and provide information about yourself to find out if you meet the requirements for participation in the study.
What are the key requirements?
- Confirmed diagnosis of advanced CRC that has spread to other parts of your body
- Be at least 12 years of age
- Recently started, or about to start, your front-line chemotherapy
You Must NOT:
- Have had prior immunotherapy
(therapy that stimulates or suppresses the immune system) or autoimmune disease (body’s immune system mistakes its own healthy tissue as foreign and attacks them)
- Have had myocardial infarction within the previous 3 months
Please talk with your doctor or nurse if you are interested in learning more about whether or not you may qualify.
How long would I be in this study?
If you sign the consent form and are found to be eligible, you’ll continue your current course of therapy for up to 6 months while your personalized vaccine is being manufactured.
The treatment period (where you receive your assigned study medication) will be up to 2 years. There will be a follow-up period of approximately 100 days. This is to check your overall health. Your total participation in the study could be approximately two years and 3 months.
What would be expected of me if I participate?
You must be willing to comply with the requirements of the study. This will include:
- Receiving the study drug as instructed by the study doctor.
- Attending all visits to check your overall health.
- Avoiding certain medications as advised by your study doctor
- Agreeing to use an acceptable method of birth control throughout your participation in the study
What should I know?
- Approximately 665 patients are expected to take part in this research study.
- There will be two treatment groups in this study. One group will receive standard of care chemotherapy together with the investigational personalized vaccine (specific to you and your tumor), which is called GRT-C901/GRT-R902, and an immunotherapy that activates the immune system. The other group will receive standard of care chemotherapy only. If you are found to be eligible for the study, you will be randomized (or randomly assigned) to one of the two treatment groups. You have a 50% chance of being assigned to receive study treatment in addition to your standard of care and a 50% chance of being assigned to receive standard of care alone.
- The study medication and all tests, procedures and visits required by the study are provided at no cost to you.
- Participation in this study is voluntary and you are free to withdraw at any time and without giving any reason.
Do you have questions?
Talk with your study doctor or nurse to find out more.
If you are interested in participating in this study, you will first discuss risks and study procedures with your study team and your family, if desired.
This research study has been reviewed by the responsible Institutional Review Board (IRB). An IRB is a group of scientists/medical experts and regular people who review any research conducted in humans to protect the welfare, rights, and privacy of the patients in the study.
Visit https://clinicaltrials.gov/ and search “Gritstone GO-010” for more information.