Immune response to a MUC1 peptide vaccine for lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the immune response generated by a MUC1 peptide vaccine in patients with non-small cell lung cancer (NSCLC). Participants will receive the vaccine subcutaneously every three weeks for three doses, with optional yearly booster shots for up to five years for those who respond positively. The study aims to characterize the anti-MUC1 immune response and assess the safety and immunogenicity of the vaccine, which has shown promise in other cancer types. The vaccine is administered alongside an adjuvant, Poly-ICLC, to enhance the immune response.

Why it matters

Who can join: the full rules

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
  * 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
* The effects of a MUC1vaccine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men and women of childbearing potential must be willing to use effective contraception (hormonal barrier method of birth control; abstinence) while on study treatment and for at least 3 months thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

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
* Prior resection of lung cancer is allowed, if at least five years have elapsed between previous resection and registration
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant women are excluded from this study. Women of childbearing potential must have a negative pregnancy test
* Subjects with immune deficiency are not expected to respond to the vaccine. Therefore, known HIV-positive patients are excluded from the study
* Subjects with a history of known autoimmune disease are excluded from this study

Where it's running

• UPMC Hillman Cancer Center
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Arjun Pennathur, MD — University of Pittsburgh Medical Center
• Study coordinator: Research Coordinator
• Email: wardj@upmc.edu
• Phone: 412-647-8583

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CR-002 study in adults with advanced solid tumors

  This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors

  Recruiting at 3 sites Phase 1/2 Crescent Biopharma, Inc. · Austin, Texas and 2 other locations · NCT07909031

• NSCLC biomarker study using tumor and blood samples to link genetics with prognosis and immunotherapy response

  Researchers will test tumor tissue and blood from about 300 NSCLC patients to find genomic and immune markers that predict prognosis and response to immunotherapy.

  Recruiting at 20 sites Hellenic Cooperative Oncology Group · Limassol and 19 other locations · NCT07900581

• Wireless home prehabilitation for older adults with NSCLC awaiting lung surgery

  This study tests whether a personalized home exercise program guided by wearable devices can improve lung function for older NSCLC patients preparing for curative lung surgery.

  Recruiting West China Hospital · Chengdu, Sichuan · NCT07809763

• First-line treatment with pembrolizumab, pemetrexed, and platinum with or without zoldonrasib for metastatic non-squamous NSCLC

  This trial tests whether adding zoldonrasib to standard pembrolizumab and platinum chemotherapy helps people with untreated metastatic non-squamous NSCLC that has a RAS G12D mutation.

  Recruiting at 4 sites Phase 3 Revolution Medicines, Inc. · Anchorage, Alaska and 3 other locations · NCT07777822

• Targeted radioligand therapy for several solid tumors using DWJ155 imaging and treatment

  A phase 1 study tests [177Lu]Lu-DWJ155 for treatment and [68Ga]Ga-DWJ155 for imaging in adults with certain breast cancers, NSCLC, GEJ cancer, or bladder cancer who have not benefited from standard therapies.

  Recruiting at 6 sites Phase 1 Novartis · Omaha, Nebraska and 5 other locations · NCT07660055

• First-in-human imaging study of 68Ga-DFC413 and comparison with 68Ga-NNS309 in solid tumors

  This study tests a new radioactive imaging agent, 68Ga-DFC413, to see how it behaves in patients with several solid tumors and compares it to 68Ga-NNS309.

  Recruiting at 2 sites Phase 1 Novartis · Odense C and 1 other locations · NCT07630961

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.