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OncoMatch/Clinical Trials/NCT06229340

Leflunomide or Combination of MEK Inhibitor and Hydroxychloroquine for Refractory Patients With RAS Mutations

Is NCT06229340 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Leflunomide and The combination of MEK inhibitor + hydroxychloroquine( plaquenil) ± bevacizumab for ras mutation.

Phase 2RecruitingN.N. Petrov National Medical Research Center of OncologyNCT06229340Data as of May 2026

Treatment: Leflunomide · The combination of MEK inhibitor + hydroxychloroquine( plaquenil) ± bevacizumabThere is a huge variety of nucleotide substitutions that activate RAS. The search for new "universal" drugs for the RAS pathway that either interfere with RAS upregulation upstream in the signaling pathway or offset the consequences of RAS activation is important for improving therapeutic outcomes for patients with refractory malignancies. The use of leflunomide or the combination of MEK inhibitor + hydroxychloroquine ± bevacizumab is promising for patients with mutations in RAS cascade genes who have failed all existing treatment standards.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Pancreatic Cancer

Non-Small Cell Lung Carcinoma

Melanoma

Tumor Agnostic

Biomarker criteria

Required: HRAS mutation

Required: KRAS mutation

Required: NRAS mutation

Disease stage

Required: Stage IV

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 2 prior lines

Lab requirements

Blood counts

ANC ≥ 1.5 x 10^9/L (1500/μL); lymphocyte count ≥ 0.5 x 10^9/L (500/μL); platelet count ≥ 100 x 10^9/L (100,000/μL) without transfusion; hemoglobin ≥ 90 g/L without transfusion

Kidney function

Creatinine clearance ≥ 40 mL/min

Liver function

Serum bilirubin ≤ 1.5 x HGH (≤ 3 x IUH for Gilbert's disease or liver metastases); AST, ALT, and alkaline phosphate ≤ 2.5 x HGN

Cardiac function

left ventricular ejection fraction (LVEF) ≥ 45%

Appropriate hematologic and liver function: ANC ≥ 1.5 x 10^9/L (1500/μL); lymphocyte count ≥ 0.5 x 10^9/L (500/μL); platelet count ≥ 100 x 10^9/L (100,000/μL) without transfusion; hemoglobin ≥ 90 g/L without transfusion. Creatinine clearance ≥ 40 mL/min. Serum albumin ≥ 25 g/L (2.5 g/dL). Serum bilirubin ≤ 1.5 x HGH, with the following exception: Patients with known Gilbert's disease or liver metastases: serum bilirubin level ≤ 3 x IUH. AST, ALT, and alkaline phosphate ≤ 2.5 x HGN; Exclusion: Impaired renal and hepatic function; - left ventricular ejection fraction (LVEF) < 45%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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