AlloStim + Anti-PD-L1 for Colorectal Cancer
(COMUNITY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination treatment for individuals with advanced colorectal cancer unresponsive to standard treatments. The focus is on an experimental immunotherapy called AlloStim, combined with a drug called Anti-PD-L1, which helps the immune system attack cancer cells. The researchers aim to determine if this approach is more effective than previous treatments. Suitable candidates have metastatic colorectal cancer and have not benefited from at least two lines of chemotherapy. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that chronic use of high-dose corticosteroids is not allowed, so you may need to adjust if you're on such medication.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that AlloStim, a type of immune cell therapy from a donor, triggers an immune response similar to that in bone marrow transplants rather than directly killing tumors. Although data on AlloStim remains limited, no strong evidence of serious safety concerns has emerged so far.
Studies have found that anti-PD-L1 therapies, which help the immune system recognize and attack cancer cells, often cause side effects. In one study, about 85% of patients experienced side effects, ranging from mild to severe, but most tolerated the treatment well.
Overall, while both treatments can cause side effects, they are generally considered manageable. Participants should discuss any concerns with their healthcare providers to better understand the potential risks and benefits.12345Why are researchers excited about this study treatment for colorectal cancer?
Researchers are excited about the combination of AlloStim and Anti-PD-L1 for colorectal cancer because it takes a novel approach to targeting the immune system. Unlike traditional treatments like chemotherapy and radiation, which directly attack cancer cells, this combination focuses on boosting the body's immune response to fight the cancer. AlloStim is an innovative therapy that stimulates immune cells, while Anti-PD-L1 blocks a protein that often helps cancer cells hide from the immune system. This dual strategy has the potential to enhance the body's natural ability to combat cancer, offering new hope for patients with colorectal cancer.
What evidence suggests that AlloStim and Anti-PD-L1 could be effective for colorectal cancer?
This trial will evaluate the combination of AlloStim and anti-PD-L1 therapy for colorectal cancer. Research has shown that AlloStim helps the body's immune system learn to attack and destroy cancer cells, which can stop them from growing and spreading. Patients with advanced colorectal cancer have experienced positive results with AlloStim, especially when other treatments have failed.
Studies have found that anti-PD-L1 therapy can assist some colorectal cancer patients by blocking a pathway that tumors use to evade the immune system. While not everyone benefits, some studies report that 20% to 50% of patients see improvements with this treatment.
Combining AlloStim with anti-PD-L1 therapy in this trial might enhance the immune system's ability to fight cancer cells, offering hope for those who haven't had success with other treatments.36789Are You a Good Fit for This Trial?
This trial is for patients with metastatic colorectal cancer that has not responded to chemotherapy or other immunotherapies and have progressed after, or cannot tolerate, treatments like Longsurf (TAS-102) with or without Avastin (bevacizumab), or Stivarga (regorafenib).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment - AlloStim® Priming
Participants receive AlloStim® administered weekly in two 21-day cycles with intradermal doses followed by an intravenous dose
Treatment - Combination Therapy
Combination of AlloStim® IV boosters and anti-PD-L1 checkpoint therapy with avelumab
Expansion Phase
An additional cycle of combined AlloStim® and avelumab for stable patients
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AlloStim
- Anti-PD-L1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mirror Biologics, Inc.
Lead Sponsor