MUC1 Vaccine + PolyICLC for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Arjun Pennathur, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Olivera Finn

Must not be taking: Steroids, Anti-immune therapy

Disqualifiers: HIV, Autoimmune disease, Hepatitis B/C, others

Stay on Your Current Meds

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{1 3 7 9 10}

Research Team

Arjun Pennathur, MD

Principal Investigator

University of Pittsburgh Medical Center

Eligibility Criteria

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.

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

Trial Timeline

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

Treatment Details

Interventions

• Vaccine + PolyICLC (Cancer Vaccine)

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.

Participant Groups

Group I: Stage IIIA or IIIB Experimental Treatment 1 Intervention

Concomitant chemo-irradiation followed by 3 cycles of vaccine + PolyICLC.

Group II: Stage IB/II/IIIA Experimental Treatment 1 Intervention

Resection and adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.

Group III: Stage IA or I/II NSCLC or neuroendocrine carcinoid tumor Experimental Treatment 1 Intervention

Resection or radiotherapy without adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.

Who Is Running the Clinical Trial?

Olivera Finn

Lead Sponsor

Trials

2

Recruited

40+

Findings from Research

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]

MUC-1 peptide-loaded non-aggregated nanoparticles (MUC-1 peptide-PLGA-NA-NPs) are smaller and more effective at cellular uptake in macrophages compared to larger aggregated nanoparticles, which could enhance their therapeutic potential in treating non-small cell lung cancer (NSCLC).

The study suggests that these non-aggregated nanoparticles could be administered via inhalation, making them a promising candidate for further investigation in NSCLC treatment models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Jyoti, K., Jain, S., Katare, OP., 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. 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]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

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

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

6. Greece pubmed.ncbi.nlm.nih.gov

Phase-I study of synthetic muc1 peptides in breast-cancer. [2019]

7. 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]

8. Germany pubmed.ncbi.nlm.nih.gov

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]

9. England pubmed.ncbi.nlm.nih.gov

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]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Natural and Induced Humoral Responses to MUC1. [2021]