Hydroxychloroquine + Encorafenib/Cetuximab for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a Phase II, open label, single-arm trial study of adding hydroxychloroquine to encorafenib and cetuximab in patients with metastatic BRAF V600E colon cancer with progression on at least 1 prior line of therapy. We hypothesize that autophagy is a major mechanism of resistance to BRAF inhibition in stage IV BRAF V600E colorectal cancer, and that the addition of hydroxychloroquine to standard encorafenib and cetuximab therapy will help overcome this resistance.
Do I need to stop my current medications to join the trial?
You will need to stop any chemotherapy or targeted therapy at least 14 days before starting the trial treatment. Additionally, you cannot take medications that strongly affect certain liver enzymes (CYP3A4/5) within 7 days before starting the trial. If you are on any other medications, it's best to discuss with the trial team to see if they are allowed.
What safety data exists for Hydroxychloroquine + Encorafenib/Cetuximab in humans?
What makes the drug combination of Hydroxychloroquine, Encorafenib, and Cetuximab unique for colorectal cancer?
This drug combination is unique because it targets colorectal cancer with a specific BRAF V600E mutation, using a combination of a BRAF inhibitor (Encorafenib) and an epidermal growth factor receptor inhibitor (Cetuximab), which is enhanced by Hydroxychloroquine. This approach is chemotherapy-free and specifically designed for patients who have already received prior treatments, offering a targeted therapy option that can improve survival rates compared to standard therapies.16789
What data supports the effectiveness of the drug combination Hydroxychloroquine + Encorafenib/Cetuximab for colorectal cancer?
Research shows that the combination of encorafenib and cetuximab improved survival in patients with a specific type of colorectal cancer (BRAFV600E mutation) compared to standard treatments. Cetuximab, when used with other drugs, has also been shown to improve outcomes in colorectal cancer patients.1241011
Who Is on the Research Team?
Devalingam Mahalingam, MBBChBAO
Principal Investigator
Northwestern University
Are You a Good Fit for This Trial?
Adults with stage IV colorectal cancer that has the BRAF V600E mutation, who have tried at least one other treatment but not BRAF inhibitors. They must be in good health otherwise, with no severe heart or eye conditions, and can't be pregnant or nursing. Participants need to have recovered from previous treatments and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive encorafenib, cetuximab or panitumumab, and hydroxychloroquine. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 3 months for 18 months.
What Are the Treatments Tested in This Trial?
Interventions
- Cetuximab
- Encorafenib
- Hydroxychloroquine
Cetuximab is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator