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
Northwestern University
43 participants
Oct 10, 2022
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
Plain Language Summary
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Interventions
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)
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NCT05576896