OncoMatch/Clinical Trials/NCT01720836
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Is NCT01720836 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Vaccine + PolyICLC for non-small cell lung cancer (nsclc).
Treatment: Vaccine + PolyICLC — All subjects will receive the vaccine subcutaneously every 3 weeks x 3 with optional yearly booster vaccines up to and including 5 years post last vaccine for those patients who are confirmed responders to the vaccine . The rationale for using Poly-ICLC as an adjuvant are two ongoing trials at University of Pittsburgh Cancer Institute (UPCI) of the MUC1 100mer peptide vaccine - one as a therapeutic vaccine in subjects with metastatic castrate resistant prostate cancer and the other in subjects with advanced colonic adenomas at risk for developing colon cancer. The same formulation, MUC1 100mer peptide admixed with Poly-ICLC, is used in both trials. There has been no toxicity observed and the vaccine is highly immunogenic in early disease. In the proposed NSCLC trial the anti-MUC1 immune response will be thoroughly characterized.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Disease stage
Required: Stage IA(T1N0), IB(T2N0), II, IIIA(N2 NEGATIVE), IIIA(N2+), IIIB(N3+)
one of the following stages: Stage IA(T1NO); IB (T2NO), II & IIIA (N2 negative); IIIA (N2+), IIIB (N3+)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard of care treatment — for their particular stage of disease
within 4 to 24 weeks of standard of care treatment for their particular stage of disease
Cannot have received: vaccine therapy
No prior vaccine therapy
Lab requirements
Blood counts
Leukocytes > 3,000/µL; Absolute Neutrophils > 1,500/µL; Hemoglobin > 10 g/dL; Platelets > 100,000/µL
Kidney function
Creatinine within normal institutional limits OR Creatinine clearance > 60 mL/min/1.73 m2 for subjects with above normal AST and ALT with alkaline phosphatase within < 1.5 times upper limit of normal
Liver function
Total Bilirubin within normal institutional limits
acceptable organ and marrow function as defined below: Leukocytes > 3,000/µL; Absolute Neutrophils > 1,500/µL; Hemoglobin > 10 g/dL; Platelets > 100,000/µL; Total Bilirubin within normal institutional limits; Creatinine within normal institutional limits OR Creatinine clearance > 60 mL/min/1.73 m2 for subjects with above normal AST and ALT with alkaline phosphatase within < 1.5 times upper limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UPMC Hillman Cancer Center · Pittsburgh, Pennsylvania
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