CYAD-101 + Chemotherapy and Immunotherapy for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of the CYAD-101-002 study is to assess the safety and clinical activity of CYAD-101 in patients with unresectable metastatic colorectal cancer administered concurrently with FOLFOX chemotherapy, followed by pembrolizumab treatment.
Will I have to stop taking my current medications?
The trial requires that you stop taking any anticancer agents and investigational agents at least 4 weeks before starting the study treatment. You also need to avoid certain growth factors and radiotherapy shortly before the trial begins. The protocol does not specify other medications, so it's best to discuss your current medications with the trial team.
Is the combination of CYAD-101, chemotherapy, and immunotherapy generally safe for humans?
The combination of immune checkpoint inhibitors (like Pembrolizumab) and chemotherapy can lead to more gastrointestinal side effects, such as diarrhea and colitis (inflammation of the colon), compared to chemotherapy alone. These side effects can vary depending on the specific drugs used in the treatment.12345
What makes the treatment CYAD-101 unique for colorectal cancer?
CYAD-101 is unique because it combines chemotherapy and immunotherapy, aiming to enhance the body's immune response against colorectal cancer, which is typically resistant to immunotherapy alone. This approach is still experimental, as immunotherapy has not yet become a standard treatment for most colorectal cancer cases.678910
What data supports the effectiveness of the drug CYAD-101 + Chemotherapy and Immunotherapy for Colorectal Cancer?
Immunotherapy, which is part of this treatment, has shown potential benefits in colorectal cancer, especially in patients with certain genetic markers (MSI-H). Additionally, chemotherapy regimens like FOLFOX are standard treatments for stage III colon cancer, known to reduce recurrence and improve survival.69111213
Are You a Good Fit for This Trial?
This trial is for adults with metastatic colorectal cancer that's not been surgically removed and doesn't respond to standard treatments. Participants must have had FOLFOX chemotherapy, be in good physical condition (ECOG 0 or 1), and have tumors measurable by RECIST criteria. They can't join if they've used certain growth factors, had major surgery, uncontrolled illnesses, live vaccines, anticancer agents or radiotherapy recently; or if they've ever received drugs like Pembrolizumab before.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
CYAD-101 is administered concurrently with FOLFOX chemotherapy, followed by pembrolizumab treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CYAD-101
- FOLFOX
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Celyad Oncology SA
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University