Dr. Michael Overman, MD Anderson in Houston, and Dr. Caio Max S. Rocha Lima, Atrium Health Wake Forest Baptist in Winston-Salem, are co-principal investigators spearheading the COMMIT trial: studying a novel treatment approach for microsatellite instability high-deficient mismatch repair (MSI-H/dMMR) metastatic colon and rectal cancers. Study participation is the key to the successful completion of the COMMIT trial and you may be able to help. 

Clinical trials may feel scary to patients, but it’s important to know that clinical trials are not a last resort. Also worth noting: Clinical trials are the best way to advance colorectal cancer treatment options.  

If you’re a patient with MSI-H/dMMR metastatic colorectal cancer, a caregiver of these patients, or if you know someone with this disease, we’ve outlined below 5 things you need to know about the COMMIT trial. 

Top 5 things patients need to know about the COMMIT trial

1. What is the goal of the COMMIT trial?  

The goal of the COMMIT trial is to see if combining immunotherapy (atezolizumab) with two other treatments -- a targeted therapy (bevacizumab) and chemotherapy (FOLFOX) -- can work better together and give patients a better chance of improving outcomes than using immunotherapy alone. 

Immunotherapy with checkpoint inhibitors has revolutionized the treatment of MSI-H/dMMR for metastatic colon and rectal cancer. Unfortunately, about 40% of the patients who are treated with immunotherapy will experience cancer progression within a year. Despite of its beneficial effects, Immunotherapy alone is not curative for most of these patients 

In an effort to improve outcomes, the COMMIT clinical trial is testing a new idea. Researchers are studying to see whether if combining immunotherapy (atezolizumab) with two other treatments -- a targeted therapy (bevacizumab) and chemotherapy (FOLFOX) -- can work better together and give patients a better chance of improving outcomes than using only immunotherapy. This treatment combination aims to improve patient outcomes by:  

• Keeping cancer cells from suppressing the immune system and, in turn, allowing the immune system to attack cancer cells (atezolizumab). 

• Stopping the blood supply to cancer cells using a targeted therapy (bevacizumab). 

• Killing cancer cells and improving the attack of the immune system to cancer cells by using a chemotherapy regimen (FOLFOX).  

But researchers need participants in the COMMIT trial to prove that the combination of FOLFOX + Bevacizumab + Atezolizumab is superior to atezolizumab alone before the combination becomes a standard of care and a treatment option for this group of patients. 

2. How do I enroll? 

Participants can enroll at one of the many sites across United States that are part of the National Cancer Institute cooperative group system. Enroll close to home by checking the Study Details tab: Look for Contacts and Locations. 

The list is in alphabetical order by state (then by city, state, participating hospital or cancer center). Please contact the person listed at each site either by phone or email, whichever is provided, for more information or to enroll.  

3. What are the potential benefits of adding chemotherapy and bevacizumab to immunotherapy when compared to immunotherapy alone in this group of patients? 

Research done before testing on humans (preclinical data) has shown that when researchers combine bevacizumab with immunotherapy, chemotherapy with immunotherapy, or all three together, it can either make the treatment stronger or work really well together to stop or slow down cancer cells. Studies done with patients (clinical data) also suggest that adding chemotherapy and bevacizumab to immunotherapy might work better than just using immunotherapy by itself. In order to confirm this is the case, researchers need to complete phase III of this trial, which is the final step before this treatment is approved by the FDA.  

4. What are the side effects?  

When chemotherapy and bevacizumab are added to immunotherapy, patients may experience additional side effects, including low blood counts (platelets, red cells, and white cells), which will recover between treatments, as well as nausea, vomiting, fatigue, neuropathy among others. Before you decide to join the trial, the researchers will explain these possible side effects in detail as part of the informed consent process. 

• Will I have additional visits to the doctor?  
  • Yes. Both regiments are given every two weeks. 

• Will the additional tests or scans be covered by the trial?  
  • Yes. Additional tests or scans will be covered by the trial.

5. Does enrollment cause me to be ineligible for subsequent trial inclusion? 

No. You may be a candidate for future trials in the second or later lines of therapy for colon and rectal cancer. Additionally, based on the unique characteristics of your cancer, you might also qualify for studies that look at different types of cancer, beyond colon and rectal cancer. Joining this trial won't close the door to other opportunities that might come up later.  

• What happens after I am in this trial and still need treatment?  
  • During the COMMIT trial, the patient’s treatment plan will last for up to two years, as long as their cancer doesn't progress, and they don't experience any severe side effects. If the patient and their medical team believe that the trial treatment is helping, they can continue. Patients are encouraged to make the best decisions for their health. 

Learn more about the COMMIT trial or enroll.

Your Guide in the Fight 

We are fighting alongside you from your day of diagnosis and beyond. You can find additional resources in our Resource Library, or here are a few quick links to help you apply this information: 

• Clinical Trials Finder 
• Provider Finder 
• Biomarkers brochure 
• Clinical Trials brochure 

To talk with someone about this information and/or ask questions, join us at our next meetup or our Community of Champions.  

Medical input and review

Caio Max S. Rocha Lima, MD, MS, Atrium Health Wake Forest Baptist in Winston-Salem 

Medical disclaimer 

The information and services provided by Fight Colorectal Cancer are for general information purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnoses or treatment. If you are ill, or suspect that you are ill, see a doctor immediately. In the event of an emergency, call 911 or go to the nearest emergency room. Fight Colorectal Cancer never recommends or endorses any specific physicians, products, or treatments for any condition.