OncoMatch/Clinical Trials/NCT05576896
Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in the Treatment of Metastatic BRAF-mutated Colorectal Cancer Refractory
Is NCT05576896 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab for stage iv colorectal cancer positive for braf v600e mutation.
Treatment: Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: BRAF v600e
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy
on at least 1 prior line of systemic therapy
Cannot have received: BRAF inhibitor
have not had any previous BRAF inhibitor therapy
Cannot have received: MEK inhibitor
Exception: BRAF or MEK inhibitors
Lab requirements
Blood counts
Leukocytes ≥ 3,000/mcL; ANC ≥ 1,500/mcL; Hemoglobin ≥ 9 g/dL (≤2 units pRBC in prior 4 weeks allowed); Platelets ≥ 100,000/mcL (≤2 units platelet transfusion in prior 2 weeks allowed)
Kidney function
Creatinine ≤ 1.5x ULN OR eGFR > 50 mL/min/1.73 m2
Liver function
Total bilirubin ≤ 1.5 x Institutional ULN; AST/ALT ≤ 2.5 x institutional ULN, or < 5x ULN in presence of liver metastases
Cardiac function
QTc interval ≤480 ms on EKG; NYHA class 2B or better; no clinically significant cardiac disease (NYHA Class III or IV heart failure excluded)
Patients must have adequate organ and bone marrow function as defined below... Patients should have a QTc interval of ≤480 ms on the EKG... NYHA class 2B or better. Patients with clinically significant cardiac disease, including New York Heart Association Class III or IV heart failure are not eligible.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Northwestern University · Chicago, Illinois
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