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OncoMatch/Clinical Trials/NCT04079179

Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders

Is NCT04079179 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cobimetinib for langerhan's cell histiocytosis.

Phase 2RecruitingCarl AllenNCT04079179Data as of May 2026

Treatment: Cobimetinib — This is a research study of a drug called cobimetinib in children and adults diagnosed with Langerhans cell histiocytosis (LCH), and other histiocytic disorders that has returned or does not respond to treatment. Cobimetinib blocks activation of a protein called Mitogen-activated protein kinase (MEK) that is part of incorrect growth signals in histiocytosis cells. Four different groups of patients will be enrolled.

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Extracted eligibility criteria

Cancer type

Sarcoma

Prior therapy

Min 1 prior line

Must have received: front-line therapy — LCH

Failure of at least front-line therapy for LCH with evaluable disease

Cannot have received: MEK inhibitor (cobimetinib)

Any prior treatment with Cobimetinib

Lab requirements

Blood counts

ANC ≥ 0.75 x 10^9/L (unsupported); Platelet count ≥ 75 x 10^9/L (unsupported); Hemoglobin ≥ 8 g/dL (unsupported); For marrow disease: transfusion support allowed

Kidney function

Creatinine clearance (or radioisotope GFR) ≥ 70 mL/min/1.73m^2 or serum creatinine based on age/gender

Liver function

Bilirubin ≤ 1.5 x ULN for age; AST and ALT ≤ 3x ULN (≤ 5 x ULN with liver involvement); serum albumin ≥ 2 g/dL. For patients with liver disease caused by histiocytic disorder: may enroll with abnormal bilirubin, AST, ALT and albumin with documentation of histiocytic liver disease.

Cardiac function

Fractional shortening (FS) ≥ 30% or ejection fraction ≥ 50% by echocardiogram or MUGA

Adequate Hematologic Function ... Adequate Renal Function ... Adequate Liver Function ... Adequate Cardiac Function

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

US trial sites

  • Phoenix Children's Hospital · Phoenix, Arizona
  • Arkansas Children's Hospital · Little Rock, Arkansas
  • Children's Hospital of Orange County · Orange, California
  • UCSF Benioff Children's Hospital · San Francisco, California
  • Children's National Hospital · Washington D.C., District of Columbia

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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