Botensilimab + Balstilimab + SBRT for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of treatments for individuals with colorectal cancer that has spread to the liver and is unresponsive to standard chemotherapy. It combines two experimental drugs, Botensilimab and Balstilimab, with a targeted radiation therapy called Stereotactic Body Radiation Therapy (SBRT). The goal is to determine if this combination is safe and effective for patients whose cancer lacks certain genetic markers. Participants should have colorectal cancer that has metastasized to the liver, has not responded to standard chemotherapy, and have at least one liver tumor untreated by radiation. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy or certain treatments within 14 days before starting the trial, and you should not be on high-dose corticosteroids or other immunosuppressive medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of botensilimab and balstilimab is generally safe. No new immune-related safety issues have emerged. In earlier research with patients who have microsatellite stable (MSS) colorectal cancer, 89% experienced treatment-related side effects. The most common side effects included fatigue and diarrhea. Although these side effects occur frequently, they are usually mild and manageable.
This study remains in an early phase, so researchers are still assessing the treatment's safety and tolerability. It is important to discuss with a healthcare provider to understand what this means for individual circumstances.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Botensilimab and Balstilimab because they offer a novel approach to treating colorectal cancer. While traditional treatments often focus on chemotherapy and radiation, Botensilimab and Balstilimab are immunotherapies that work by enhancing the body's own immune response to attack cancer cells. Botensilimab is a monoclonal antibody that targets the CTLA-4 protein, while Balstilimab targets the PD-1 pathway. By using these two together, they aim to unleash a more powerful immune attack on the cancer, potentially leading to better outcomes for patients. This combination could offer a new hope for those who have not responded well to standard therapies.
What evidence suggests that this trial's treatments could be effective for colorectal cancer?
Research has shown that the combination of Botensilimab and Balstilimab may hold promise for treating colorectal cancer. In this trial, participants will receive Stereotactic Body Radiation Therapy (SBRT) alongside Botensilimab and Balstilimab. One study found that patients with advanced colorectal cancer who received this combination lived for a median of about 21 months, with half living longer. Another study reported that about 70% of patients experienced stable disease or better, meaning their cancer did not worsen. Additionally, the treatment reduced cancer size by 30% in some patients. These findings suggest that the Botensilimab and Balstilimab combination could be an effective option for those with advanced colorectal cancer.13467
Who Is on the Research Team?
Theodore S. Hong, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adults with colorectal cancer that has spread to the liver and isn't responding to standard treatments. They must have tried or be intolerant to certain chemotherapies, have a life expectancy over 3 months, good performance status, and meet specific organ function criteria. Pregnant individuals or those with autoimmune diseases, uncontrolled illnesses, recent vaccines, or certain infections cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants receive standard of care SBRT for 2-3 weeks to control liver lesions
Treatment
Participants receive botensilimab and balstilimab for up to 24 weeks, followed by balstilimab alone for 14 additional 6-week cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Balstilimab
- Botensilimab
- Stereotactic Body Radiation Therapy (SBRT)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Agenus Inc.
Industry Sponsor