A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
This study, named MK-1084-012/KANDLELIT-012, is for people in the UK with advanced bowel cancer (colorectal cancer) that has spread or can't be removed by surgery. Specifically, it's for those whose cancer has a particular gene change called KRAS G12C. Standard treatment often involves chemotherapy like mFOLFOX6, sometimes with another drug called bevacizumab. In this study, doctors are investigating if adding a new drug, calderasib, along with another targeted therapy called cetuximab, to the mFOLFOX6 chemotherapy could be a more effective treatment. The main goals are to check if this new combination is safe, if people can tolerate it well, and if it helps people live longer without their cancer getting worse.
At a glance
What is this study about?
When bowel cancer, which can affect the colon or rectum, is advanced, it means it has spread to other parts of the body or is too difficult to remove with surgery. For some people, these advanced cancers have a specific change in a gene called KRAS G12C. Doctors are always looking for better ways to treat these cancers.
One common treatment for advanced bowel cancer is a chemotherapy combination called mFOLFOX6, which might sometimes be given with a drug called bevacizumab. This study wants to see if adding two other drugs – calderasib (the new study medicine) and cetuximab – to the mFOLFOX6 chemotherapy could improve treatment for people with the KRAS G12C gene change. Both calderasib and cetuximab are 'targeted therapies,' which means they are designed to attack specific features of cancer cells.
The main reasons for doing this study are to find out two key things. Firstly, how safe is this new combination of calderasib, cetuximab, and mFOLFOX6, and how well do people tolerate it? Secondly, researchers want to see if people who receive this new combination live longer without their cancer growing or spreading, compared to those who get the standard mFOLFOX6 treatment, with or without bevacizumab. This will help doctors understand if the new treatment offers a better option for people with this type of advanced bowel cancer.
Key takeaways
- This study is for advanced bowel cancer with a specific genetic change (KRAS G12C).
- It's comparing a new drug combination with standard chemotherapy.
- The main goals are to check safety, tolerability, and cancer control.
- Participation involves regular hospital visits for treatments and monitoring.
- You have the right to leave the study at any time.
- It's important to discuss this option thoroughly with your cancer doctor.
Who may be eligible?
To join this study, you would need to have bowel cancer that has either spread to other parts of your body (metastatic) or is too advanced to be removed by surgery. A crucial requirement is that your cancer must have a specific genetic change called KRAS G12C. For one part of the study, you shouldn't have had previous treatments for your advanced bowel cancer, though a short course of chemotherapy before the study might be allowed.
There are also some health conditions that would prevent you from joining. For example, if you have severe heart or brain conditions that aren't well controlled, or if you have certain bowel conditions like Crohn's disease or ulcerative colitis that need strong medicines. Also, if you know you have a partial or complete deficiency in a specific enzyme called DPD, or if doctors think other existing health issues would make treatment with bevacizumab unsafe for you, you couldn't take part.
However, if you have well-managed HIV, or if you've had Hepatitis B or C but your viral levels are undetectable with treatment, you might still be able to join. The study is open to both men and women, aged 18 and over.
- Do I have advanced bowel cancer (colon or rectal)?
- Has my cancer been tested for the KRAS G12C gene change, and is it present?
- Have I had no or very little previous treatment for my advanced cancer?
- Do I have well-controlled other medical conditions, like heart issues?
- Am I aged 18 or over?
- Do I understand and agree to the basic rules of the study?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, it will involve two main stages. You will receive either the new combination treatment (calderasib with cetuximab and mFOLFOX6) or the standard treatment (mFOLFOX6, with or without bevacizumab).
Throughout the study, you'll have regular hospital visits for examinations, blood tests, and scans to monitor your health and how the treatment is working. This will help doctors check for any side effects and see if your cancer is responding. The doctors will explain exactly what your treatment schedule will look like, including how often you'll need to visit and for how long. The total duration of your participation will depend on how you respond to the treatment and the study's protocol, but you will be monitored and followed up for a period even after treatment stops.
Potential risks and benefits
Locations (192)
- Los Angeles Hematology Oncology Medical Group ( Site 0084)Los Angeles, United States· Recruiting
- University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0087)Fort Collins, United States· Recruiting
- Rocky Mountain Cancer Centers (RMCC) ( Site 8000)Lone Tree, United States· Recruiting
- Florida Cancer Specialists - South ( Site 7002)Fort Myers, United States· Recruiting
- Orlando Health Cancer Institute ( Site 0065)Orlando, United States· Recruiting
- Florida Cancer Specialists - North ( Site 7001)St. Petersburg, United States· Recruiting
- Florida Cancer Specialists - East ( Site 7000)West Palm Beach, United States· Recruiting
- University of Iowa ( Site 0074)Iowa City, United States· Recruiting
- University of Kentucky ( Site 0055)Lexington, United States· Recruiting
- Norton Cancer Institute, Audubon Hospital Campus ( Site 0054)Louisville, United States· Recruiting
- Greater Baltimore Medical Center ( Site 0068)Baltimore, United States· Recruiting
- Hattiesburg Clinic ( Site 0064)Hattiesburg, United States· Recruiting
+180 more sites — see the official record for the full list.
Common questions
What is 'advanced bowel cancer'?
Advanced bowel cancer means the cancer has spread from where it started to other parts of your body, or it's too difficult to remove surgically.
What is a 'KRAS G12C mutation'?
This is a specific change in a gene found in some cancer cells. This study is specifically for people whose bowel cancer has this particular gene change.
Are the study drugs already available?
Some drugs are standard treatments, but calderasib is a new experimental drug being tested in this study to see if it's safe and effective.
Will I know which treatment I'm getting?
Often in studies, participants are randomly assigned to a treatment group. The study team will explain if you will know which treatment you are receiving.
Who is running this study?
This study is sponsored by a pharmaceutical company and is being conducted by medical researchers and doctors at various hospitals.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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