PolyPEPI1018 + Atezolizumab for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received certain anticancer therapies, live vaccines, or systemic corticosteroids shortly before starting the trial. It's best to discuss your specific medications with the trial team.
What makes the drug combination of PolyPEPI1018 and Atezolizumab unique for colorectal cancer?
The combination of PolyPEPI1018 and Atezolizumab is unique because it targets the immune system to fight colorectal cancer, specifically by blocking PD-L1, a protein that helps cancer cells evade the immune system. This approach is particularly promising for patients with a specific genetic makeup (dMMR) that makes them more responsive to immune checkpoint inhibitors like Atezolizumab.12345
What data supports the effectiveness of the drug Atezolizumab for colorectal cancer?
Who Is on the Research Team?
Joleen M Hubbard
Principal Investigator
Mayo Clinic
Hagop Youssoufian, MD
Principal Investigator
Treos Bio Ltd.
Are You a Good Fit for This Trial?
Adults over 18 with metastatic colorectal cancer (MSS CRC) who have tried and progressed on 2-3 prior treatments can join this trial. They must be in good physical condition, not pregnant or breastfeeding, willing to undergo biopsies and provide consent. Excluded are those with autoimmune diseases, recent vaccines or surgeries, active infections like HIV/HBV/HCV, CNS metastases, history of severe allergies to vaccines or proteins.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PolyPEPI1018 vaccine and atezolizumab every 3 weeks until documented progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- PolyPEPI1018
Atezolizumab is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Treos Bio Limited
Lead Sponsor
Mayo Clinic
Collaborator
Hoffmann-La Roche
Industry Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University