OncoMatch/Clinical Trials/NCT04079179
Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders
Is NCT04079179 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Cobimetinib for langerhan's cell histiocytosis.
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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Sarcoma
Demographics
Prior therapy
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 →Frequently asked questions
Is NCT04079179 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior MEK inhibitor disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages