Learn about a new clinical study for people with early stage colorectal cancer
What is the goal of this clinical study?
The main purpose of this study is to learn how zanzalintinib works either alone or in combination with MK-3475A (pembrolizumab) using Signatera™ to detect and measure circulating tumor DNA (ctDNA) in the blood. Changes in ctDNA levels can be tracked over time to determine the risk that colorectal cancer will come back.
Can I join this study?
You may be able to join this study if you:
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Were diagnosed with stage II or III colorectal cancer (CRC) and recently finished treatment that included surgery and chemotherapy
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Have no signs of cancer on imaging scans such as CT or MRI scans
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Had a special blood test, called the Signatera™ test, that found small pieces of tumor DNA, called circulating tumor DNA (ctDNA), in your blood
There are other requirements you must meet to join the study.
To get a list of questions to ask the study staff, other members of your healthcare team, and family or friends, click the button below.
What study drug will I get?
Researchers will assign participants by equal chance to 1 of 3 study groups:
The current standard of care is observation, meaning no active treatment. A placebo is used in this study to help researchers determine whether the study drug provides greater benefit than no treatment. Placebos help researchers better understand the effects of study drugs. Using a placebo ensures the patient experience of receiving treatment is consistent across the study.
What is zanzalintinib?
Zanzalintinib is a study drug that is a type of tyrosine kinase inhibitor (TKI). TKIs are thought to slow or stop signals that tell cells to grow, divide, and spread. By blocking these signals, TKIs may slow tumor growth in some types of cancer.
Zanzalintinib is taken by mouth as a pill every day. Zanzalintinib is not chemotherapy.
Zanzalintinib is not approved by regulatory authorities. Researchers are studying its safety and effects in this clinical study.
What is MK-3475A?
MK-3475A is an immunotherapy given as an injection under the skin once every 3 weeks. It is a combination of the drug pembrolizumab and an ingredient that helps the body absorb pembrolizumab when given under your skin. An immunotherapy is a type of treatment that works with the immune system to fight cancer.
MK-3475A is approved by the U.S. FDA to treat certain types of cancer. However, it is not approved to be given with zanzalintinib for CRC.
Will I have any costs if I join this study?
The study will cover the cost of the study drug and any study visits, tests, and assessments that are not part of your usual care.
You, or your insurance, will continue to pay for your usual care, which is the care you would receive even if you were not in the study. This includes care for ongoing conditions like high blood pressure, diabetes, or heart problems.
You may be paid back (reimbursed) for certain travel costs to study visits. Ask the study staff to learn more about this and about transportation options for study visits.
Is there a study site near me?
Is there a study site near me?
The map below shows the cities with study sites. To find the addresses of study sites and see if more study sites have been added, go to the study on ClinicalTrials.gov and scroll down to “Contacts and Locations”.
Who do I contact to learn more about this study?
To learn more about the study and find a study site near you:
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Contact the study sponsor, Exelixis:
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Email medinfo@exelixis.com
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Call (888) 393-5494 or (303) 389-1847
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Who do I contact to learn more about this study?
To learn more about the study and find a study site near you:
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Go to ClinicalTrials.gov
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Contact the study sponsor, Exelixis:
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Email medinfo@exelixis.com
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Call (888) 393-5494 or (303) 389-1847
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Resources
The following third-party sites can provide information and resources for people living with colorectal cancer. They provide educational materials, including webinars and participant guides, and information about support groups.
These are third-party organizations that are not owned or controlled by Exelixis, Inc. Exelixis, Inc. makes no representation regarding the content, accuracy, or completeness of the information provided by these organizations and on these third-party websites. Use and access to the information on these third-party websites is subject to the terms, limitations, and conditions set by those websites.