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Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer

Study of the Immunogenicity of the MUC1 Peptide - Poly-ICLC (Polyinosinic-polycytidylic Acid Stabilized With Polylysine and Carboxymethylcellulose) OR HILTONOL™ Adjuvant Vaccine in Patients With Localized and Locally Advanced Non-Small Cell Lung Cancer

NCT01720836•Olivera Finn

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) or neuroendocrine carcinoid tumor
•All subjects must have one of the following stages: Stage IA(T1NO); IB (T2NO), II \& IIIA (N2 negative); IIIA (N2+), IIIB (N3+)
•Patients must have stable disease at the time of enrollment
•Women and men at least 18 years of age
•ECOG performance status 0-1(Appendix A)
•Subjects must be within 4 to 24 weeks of standard of care treatment for their particular stage of disease
•Subjects must have acceptable organ and marrow function as defined below:
•* Leukocytes \> 3,000/µL
•* Absolute Neutrophils \> 1,500/µL
•* Hemoglobin \> 10 g/dL
+5 more criteria

Exclusion Criteria

•Subjects may not be receiving any other investigational agents
•\- No history of prior malignancy, except for non-melanoma skin cancer
•Any positive ANA titer above 1:160, even in an asymptomatic individual. Note:
•Weakly positive ANA defined as ANA titers up to 1:160 maximum (≤ 1:160) will be acceptable in an asymptomatic individual who is otherwise eligible for the study.
•Known Hepatitis B on immunomodulators (i.e. interferon)
•Known Hepatitis C on immunomodulators (i.e. interferon)
•No prior vaccine therapy
•Patients may not be receiving any steroids or other anti-immune therapy at the time of registration.
•Subjects must not be more than 24 weeks from standard of care treatment for their particular stage of disease
•Subjects must not have post-obstructive pneumonia or other serious infection at the time of registration or other serious underlying medical condition that would impair the ability of the subjects to receive protocol treatment
+5 more criteria

Locations (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

November 1, 2012

Primary Completion Date

October 1, 2027

Completion Date

October 1, 2032

Last Updated

October 21, 2025

Enrollment

ESTIMATED participants

Conditions

Non-small Cell Lung Cancer (NSCLC)

Interventions

Vaccine + PolyICLC

BIOLOGICAL

Contacts

Research Coordinator

CONTACT

412-647-8583 wardj@upmc.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

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