RecruitingPhase 2NCT05576896

Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in the Treatment of Metastatic BRAF-mutated Colorectal Cancer Refractory

A Single-Arm, Phase II Study of Autophagy Modulation Using Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in Metastatic BRAF-mutated Colorectal Cancer Refractory to Standard Therapies


Sponsor

Northwestern University

Enrollment

43 participants

Start Date

Oct 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding hydroxychloroquine (a drug that blocks a cellular recycling process called autophagy) to a standard treatment regimen — encorafenib and cetuximab or panitumumab — can improve outcomes for people with metastatic colorectal cancer that has a BRAF V600E mutation. **You may be eligible if...** - You are 18 or older - You have stage IV colorectal cancer with a confirmed BRAF V600E mutation - You have received at least one prior chemotherapy or targeted therapy for your cancer - You have not had prior BRAF inhibitor therapy - You have measurable disease and are in good overall health (ECOG 0–1) **You may NOT be eligible if...** - You have not yet had any treatment for your metastatic colorectal cancer - You have already received BRAF inhibitor therapy - Your performance status or organ function does not meet study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab

Prior to starting therapy, patients will have a pretreatment cross-sectional scan. Patients will then begin with encorafenib 300 mg daily starting with Cycle 1 day 1; then patients will receive IV cetuximab weekly, with 400 mg/m2 on C1D1 as a loading dose and 250 mg/m2 on all other days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.


Locations(1)

Northwestern University

Chicago, Illinois, United States

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NCT05576896


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