Botensilimab + Balstilimab for Colorectal Cancer
(BATTMAN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two new immunotherapy drugs, botensilimab and balstilimab, to determine if they help people with colorectal cancer that can't be surgically removed live longer and improve their quality of life. Researchers aim to find out if these drugs can slow down or shrink tumors and identify any markers in the tumor or blood that predict these benefits. The trial will also confirm the drugs' safety and how quickly the body processes them. People with colorectal cancer who have tried all other treatments without success and are currently receiving supportive care might be a good fit for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to access potentially life-extending treatments.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop using immunosuppressive medications within 7 days before starting the study drugs, except for certain low-dose corticosteroids. Additionally, you must not have received anti-cancer chemotherapy, biologic therapy, or radiotherapy within a specific period before the trial.
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 for people. In studies with these drugs, most patients did not experience serious side effects. Some patients maintained stable disease, meaning their cancer did not worsen. About 17% of patients even had a positive response, with their cancer shrinking or growing more slowly.
Reports indicate promising survival outcomes in patients with advanced cancers. For instance, survival rates after two years were encouraging. This suggests that while side effects can occur, they might be manageable for many patients.
These drugs remain under testing, so researchers closely monitor them for safety. Considering joining a trial is a good sign that researchers are diligently working to ensure these treatments are safe.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Botensilimab and Balstilimab for colorectal cancer because these treatments offer a fresh approach compared to standard therapies like chemotherapy and targeted therapies. Botensilimab and Balstilimab work by boosting the immune response against cancer cells, which is a different mechanism than traditional treatments. By enhancing the body's natural defenses, these drugs have the potential to improve outcomes for patients who may not respond to existing options. This novel strategy of combining immune system activation with standard care could lead to more effective and durable responses in fighting colorectal cancer.
What evidence suggests that this trial's treatments could be effective for colorectal cancer?
Research shows that combining botensilimab and balstilimab may offer promise for treating colorectal cancer. In earlier studies, this combination achieved a 17% objective response rate (ORR), with some tumors shrinking. Patients experienced a median progression-free survival (PFS) of 4 months, meaning the cancer did not worsen during this time. More encouragingly, the median overall survival (OS) was about 21 months. Approximately 70% of patients had stable disease or better, suggesting the treatment might help control cancer growth. In this trial, participants will receive either the combination of botensilimab and balstilimab with best supportive care or best supportive care alone. These results suggest this combination could be a promising option for those with colorectal cancer that cannot be surgically removed.16789
Who Is on the Research Team?
Jonathan Loree
Principal Investigator
BCCA-Vancouver Cancer Centre
Are You a Good Fit for This Trial?
This trial is for adults over 18 with colorectal adenocarcinoma that can't be removed by surgery and hasn't responded to other treatments. Participants need good organ function, an ECOG status of 0 or 1 (which means they are fully active or restricted in physically strenuous activity), and a life expectancy of at least 12 weeks. They must also be willing to complete questionnaires in English or French.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive botensilimab and balstilimab along with best supportive care
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Balstilimab
- Botensilimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Canadian Cancer Trials Group
Lead Sponsor
Australasian Gastro-Intestinal Trials Group
Collaborator
Agenus Inc.
Industry Sponsor
UNICANCER
Collaborator