What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapy and chemotherapy. Immunotherapy agents such as pembrolizumab and durvalumab can cause immune-related side effects including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Chemotherapy agents, particularly platinum-based drugs like cisplatin and carboplatin, often result in side effects such as nausea, vomiting, nephrotoxicity, ototoxicity, and myelosuppression. Combining these treatments can enhance efficacy but also increases the risk of compounded side effects.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of Non-Small Cell Lung Cancer (NSCLC). Pembrolizumab (Keytruda) and nivolumab (Opdivo) are PD-1 inhibitors that have been approved for use in various settings of NSCLC, often in combination with chemotherapy. Atezolizumab (Tecentriq), a PD-L1 inhibitor, has also been approved for NSCLC treatment. These drugs work by enhancing the immune system's ability to target and destroy cancer cells. While these treatments are not identical to the MUC1 100mer peptide vaccine admixed with Poly-ICLC, they share the common goal of leveraging the immune system to fight cancer.

What other types of research exist?

Promising novel alternatives for NSCLC patients include immune checkpoint inhibitors such as pembrolizumab and atezolizumab, which have shown improved survival outcomes in clinical trials. Pembrolizumab, in particular, has been approved for use in patients with PD-L1 expression and has demonstrated durable responses. Another alternative is the combination of durvalumab with platinum-etoposide, which has also shown improved survival rates in extensive-stage small cell lung cancer. These treatments leverage the body's immune system to target and destroy cancer cells, similar to the MUC1 100mer peptide vaccine approach.

← Back to Search

Cancer Vaccine

MUC1 Vaccine + PolyICLC for Non-Small Cell Lung Cancer

Phase 1 & 2

Recruiting

Led By Arjun Pennathur, MD

Research Sponsored by Olivera Finn

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have stable disease at the time of enrollment

ECOG performance status 0-1(Appendix A)

Must not have

No history of prior malignancy, except for non-melanoma skin cancer

Patients may not be receiving any steroids or other anti-immune therapy at the time of registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

No significant toxicity has been observed in similar ongoing trials using the same vaccine formulation. However, as it's an immunotherapy, potential side effects may include mild injection site reactions or flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My disease has not worsened recently.

Select...

I am fully active or can carry out light work.

Select...

My blood tests show my organs are functioning well.

Select...

My cancer is confirmed as non-small cell lung cancer or neuroendocrine carcinoid tumor.

Select...

My cancer is at an early or mid-stage, not the most advanced.

Select...

I started my standard cancer treatment between 1 to 6 months ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have never had cancer, except possibly for non-melanoma skin cancer.

Select...

I am not taking steroids or any immune system treatments currently.

Select...

I do not have a serious infection or condition that would prevent me from receiving treatment.

Select...

I am being treated for Hepatitis B with immune system medications.

Select...

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Select...

I am being treated for Hepatitis C with immune system medications.

Select...

I do not have HIV.

Select...

I have not received any vaccine therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Immunologic response

Secondary study objectives

Anti-MUC1 immunity

Association between baseline MUC1 immunity and vaccine

Immunocompetence versus immunosuppression

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapy, targeted therapy, chemotherapy, and radiation therapy. Immunotherapy, such as the MUC1 100mer peptide vaccine admixed with Poly-ICLC, works by stimulating the body's immune system to recognize and attack cancer cells. The MUC1 100mer peptide induces an immune response specifically against MUC1-expressing cancer cells, while Poly-ICLC acts as an adjuvant to enhance this immune response. This approach is significant for NSCLC patients as it offers a targeted method to combat cancer with potentially fewer side effects compared to traditional therapies. Other treatments like targeted therapy focus on specific genetic mutations in cancer cells, while chemotherapy and radiation therapy aim to kill rapidly dividing cells but can affect normal cells as well.

Enhancing the immune stimulatory effects of cetuximab therapy through TLR3 signalling in Epstein-Barr virus (EBV) positive nasopharyngeal carcinoma.CAF05: cationic liposomes that incorporate synthetic cord factor and poly(I:C) induce CTL immunity and reduce tumor burden in mice.