30 Participants Needed

MUC1 Vaccine + PolyICLC for Non-Small Cell Lung Cancer

JW
JF
Overseen ByJudy Forster, RN, BSN, BS
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial involves giving a special vaccine to patients with non-small cell lung cancer. The vaccine aims to help the immune system recognize and attack cancer cells. The goal is to see if this approach can effectively boost the body's natural defenses against lung cancer.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on steroids or other anti-immune therapy. You also cannot be on any other investigational agents.

Is the MUC1 Vaccine + PolyICLC safe for humans?

The MUC1 vaccine, tested in various forms and conditions, has shown an excellent safety profile in multiple studies, with only mild and self-limiting side effects like flu-like symptoms and injection site tenderness. No significant long-term adverse effects have been reported, making it generally safe for human use.12345

What makes the MUC1 Vaccine + PolyICLC treatment unique for non-small cell lung cancer?

The MUC1 Vaccine + PolyICLC treatment is unique because it targets the MUC1 protein, which is often overexpressed in cancer cells, and aims to stimulate the immune system to attack these cells. This approach is different from traditional treatments like chemotherapy, as it focuses on enhancing the body's immune response specifically against cancer cells, potentially leading to fewer side effects.14678

What data supports the effectiveness of the MUC1 Vaccine + PolyICLC treatment for non-small cell lung cancer?

Research shows that a similar MUC1 peptide vaccine, L-BLP25, has shown promising results in improving survival in patients with non-small cell lung cancer. Additionally, MUC1-based vaccines have been effective in generating immune responses and reducing tumor burden in preclinical studies.127910

Who Is on the Research Team?

AP

Arjun Pennathur, MD

Principal Investigator

University of Pittsburgh Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with stable non-small cell lung cancer who are within 4-24 weeks post-standard treatment. They must have good organ and marrow function, no autoimmune diseases, not be on immune therapies or steroids, and agree to use contraception. Those with a history of certain cancers or serious illnesses are excluded.

Inclusion Criteria

My disease has not worsened recently.
I am fully active or can carry out light work.
My blood tests show my organs are functioning well.
See 4 more

Exclusion Criteria

I have never had cancer, except possibly for non-melanoma skin cancer.
I am not taking steroids or any immune system treatments currently.
Subjects may not be receiving any other investigational agents
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MUC1 peptide vaccine with Poly-ICLC subcutaneously every 3 weeks for 3 cycles

9 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including immunologic response and survival

2 years

Extension

Optional yearly booster vaccines for confirmed responders up to 5 years post last vaccine

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Vaccine + PolyICLC
Trial Overview The study tests a MUC1 peptide vaccine combined with PolyICLC given subcutaneously every three weeks for three doses, plus optional yearly boosters up to five years for responders. It aims to stimulate an immune response against lung cancer cells without causing significant toxicity.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Stage IIIA or IIIBExperimental Treatment1 Intervention
Concomitant chemo-irradiation followed by 3 cycles of vaccine + PolyICLC.
Group II: Stage IB/II/IIIAExperimental Treatment1 Intervention
Resection and adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.
Group III: Stage IA or I/II NSCLC or neuroendocrine carcinoid tumorExperimental Treatment1 Intervention
Resection or radiotherapy without adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Olivera Finn

Lead Sponsor

Trials
2
Recruited
40+

Published Research Related to This Trial

L-BLP25, a peptide vaccine targeting the MUC1 protein, has shown a strong safety profile and induced a significant immune response in preclinical studies, leading to T-cell proliferation and IFN-gamma production.
In a randomized phase II trial for patients with stage IIIB/IV non-small cell lung cancer, L-BLP25 demonstrated a median survival of 30.6 months compared to 13.3 months for best supportive care, particularly benefiting those with locoregional stage IIIB disease.
L-BLP25: a peptide vaccine strategy in non small cell lung cancer.Sangha, R., Butts, C.[2020]
Three different vaccines targeting the MUC1 tumor-associated antigen were tested for their ability to boost immunity and reject tumors in mice, revealing that only the dendritic cell (DC) vaccine effectively induced T cell immunity and led to tumor rejection.
While adjuvant-based vaccines generated antibody responses, they did not stimulate T cell responses or prevent tumor growth, highlighting the importance of T cell-mediated immunity for effective cancer treatment.
Three different vaccines based on the 140-amino acid MUC1 peptide with seven tandemly repeated tumor-specific epitopes elicit distinct immune effector mechanisms in wild-type versus MUC1-transgenic mice with different potential for tumor rejection.Soares, MM., Mehta, V., Finn, OJ.[2022]
The MUC1-based tricomponent vaccine, when combined with the adjuvant fibroblast stimulating lipopeptide 1 (FSL-1), successfully triggered both humoral and cellular immune responses against cancer cells.
This vaccine not only generated antibodies that effectively targeted MCF-7 tumor cells but also significantly reduced tumor burden, indicating its potential efficacy as an antitumor treatment.
Design of a MUC1-based tricomponent vaccine adjuvanted with FSL-1 for cancer immunotherapy.Li, M., Wang, Z., Yan, B., et al.[2020]

Citations

L-BLP25: a peptide vaccine strategy in non small cell lung cancer. [2020]
Three different vaccines based on the 140-amino acid MUC1 peptide with seven tandemly repeated tumor-specific epitopes elicit distinct immune effector mechanisms in wild-type versus MUC1-transgenic mice with different potential for tumor rejection. [2022]
Design of a MUC1-based tricomponent vaccine adjuvanted with FSL-1 for cancer immunotherapy. [2020]
A review of vaccine clinical trials for non-small cell lung cancer. [2019]
Antitumor efficacy of MUC1-derived variable epitope library treatments in a mouse model of breast cancer. [2022]
Phase-I study of synthetic muc1 peptides in breast-cancer. [2019]
Phase I study of the BLP25 (MUC1 peptide) liposomal vaccine for active specific immunotherapy in stage IIIB/IV non-small-cell lung cancer. [2021]
Phase I study of a MUC1 vaccine composed of different doses of MUC1 peptide with SB-AS2 adjuvant in resected and locally advanced pancreatic cancer. [2008]
Non-small cell lung cancer tumour antigen, MUC-1 peptide-loaded non-aggregated poly (lactide-co-glycolide) nanoparticles augmented cellular uptake in mouse professional antigen-presenting cells: optimisation and characterisation. [2020]
Natural and Induced Humoral Responses to MUC1. [2021]
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