MUC1 Vaccine for Lung Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Steroids, Anti-immune therapy

Disqualifiers: Malignancy, Hepatitis, HIV, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 10 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This pilot phase I trial studies the side effects and how well MUC1 peptide-Poly-ICLC vaccine works in preventing lung cancer in current and former smokers at high risk for lung cancer. Vaccines made from peptides may help the body build an effective immune response to kill cells. MUC1 peptide-Poly-ICLC vaccine may stimulate the body's immune system and slow or stop the changes from normal to pre-cancer to 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 participate if you have used oral or systemic steroids or other systemic anti-immune therapy within 90 days before joining. Inhaled or nasal steroids and local steroid injections for pain are allowed.

What data supports the effectiveness of the MUC1 Peptide-Poly-ICLC Vaccine treatment for lung cancer?

Research on a similar MUC1-targeting vaccine, L-BLP25, showed promising results in lung cancer patients, with a significant survival benefit in a subgroup of patients. Additionally, MUC1-targeting vaccines have been shown to induce immune responses that may help control tumor growth. ^{1 2 3 4 5}

Is the MUC1 Vaccine for Lung Cancer safe for humans?

The MUC1 vaccine, tested in lung cancer patients, was generally well tolerated with mild and temporary side effects. In a study, some patients experienced minor blood cell changes, but no serious long-term issues were reported, indicating a good safety profile. ^{1 2 3 6 7}

How does the MUC1 Vaccine for Lung Cancer differ from other treatments?

The MUC1 Vaccine for Lung Cancer is unique because it targets the MUC1 protein, which is often overexpressed in cancer cells, using a peptide-poly-ICLC vaccine to stimulate the immune system to attack these cells. This approach is different from traditional treatments like chemotherapy, as it aims to harness the body's own immune response to fight the cancer. ^{1 4 7 8 9}

Research Team

Arjun Pennathur

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

This trial is for current or former smokers with a high risk of lung cancer, who have good physical health and normal organ function. Participants should not be pregnant, must agree to use contraception if necessary, and cannot have had any other cancers (with some exceptions), hepatitis B or C, HIV, certain liver diseases, strong allergic reactions to similar vaccines, uncontrolled illnesses that could affect the study's outcome, or autoimmune diseases.

Inclusion Criteria

Creatinine =< institutional upper limit of normal (ULN)

Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) =< 1.5 x institutional upper limit of normal (ULN)

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Receiving any other investigational agents

I am HIV positive.

Known autoimmune disease

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MUC1 peptide-Poly-ICLC vaccine subcutaneously at weeks 0, 2, and 10

10 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks

1 visit (in-person) at week 28

Treatment Details

Interventions

• MUC1 Peptide-Poly-ICLC Vaccine

Trial Overview The trial is testing a MUC1 peptide-Poly-ICLC vaccine designed to prevent lung cancer by helping the immune system fight off potential cancer cells. It's in an early phase to see how well it works and what side effects it might cause when given to people at high risk due to their smoking history.

Participant Groups

Group I: Prevention (MUC1 peptide-Poly-ICLC vaccine) Experimental Treatment 2 Interventions

Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

L-BLP25: a peptide vaccine strategy in non small cell lung cancer. Sangha, R., Butts, C.[2020]

The study developed a Variable Epitope Library (VEL) vaccine platform targeting MUC1, an overexpressed antigen in tumors, which showed promising results in reducing tumor size compared to traditional wild-type peptide treatments.

Vaccination with the VEL immunogens not only reduced tumor area but also decreased lung metastasis and generated a strong CD8+ T cell response, indicating potential for effective cancer immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antitumor efficacy of MUC1-derived variable epitope library treatments in a mouse model of breast cancer. Odales, J., Servín-Blanco, R., Martínez-Cortés, F., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

MUC1 is a protein that, when overexpressed and improperly modified, can trigger immune responses that may help improve survival rates in various cancers, including breast and pancreatic cancers.

Initial studies of MUC1-based vaccines have shown them to be safe and capable of inducing immune responses, suggesting they could be effective in preventing cancer recurrence and enhancing immune surveillance in high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Natural and Induced Humoral Responses to MUC1. Von Mensdorff-Pouilly, S., Moreno, M., Verheijen, RH.[2021]

Vaccines designed to enhance tumor antigen recognition in non-small cell lung cancer patients show promising results, including prolonged stable disease and tumor shrinkage, with no reported toxicity.

Specific vaccines such as LBLP25, TGF-beta2 antisense gene vaccine, and GVAX have demonstrated potential benefits that warrant further Phase III clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of vaccine clinical trials for non-small cell lung cancer. Nemunaitis, J., Nemunaitis, J.[2019]

The BLP25 liposomal vaccine was well tolerated in patients with advanced non-small-cell lung cancer, with only mild and self-limiting side effects reported, indicating a favorable safety profile.

Immunological responses were observed, with 5 out of 12 patients generating cytotoxic T lymphocytes against MUC1-positive tumor cells, suggesting potential for further development despite no significant antitumor responses noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of the BLP25 (MUC1 peptide) liposomal vaccine for active specific immunotherapy in stage IIIB/IV non-small-cell lung cancer. Palmer, M., Parker, J., Modi, S., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a MUC1-based tricomponent vaccine adjuvanted with FSL-1 for cancer immunotherapy. Li, M., Wang, Z., Yan, B., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

L-BLP25: a peptide vaccine strategy in non small cell lung cancer. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Antitumor efficacy of MUC1-derived variable epitope library treatments in a mouse model of breast cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Natural and Induced Humoral Responses to MUC1. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A review of vaccine clinical trials for non-small cell lung cancer. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Phase I study of the BLP25 (MUC1 peptide) liposomal vaccine for active specific immunotherapy in stage IIIB/IV non-small-cell lung cancer. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Design of a MUC1-based tricomponent vaccine adjuvanted with FSL-1 for cancer immunotherapy. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

ImMucin: a novel therapeutic vaccine with promiscuous MHC binding for the treatment of MUC1-expressing tumors. [2011]

9. United States pubmed.ncbi.nlm.nih.gov

Immunization of chimpanzees with tumor antigen MUC1 mucin tandem repeat peptide elicits both helper and cytotoxic T-cell responses. [2008]