Peptide Vaccine for ALK+ Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Vincent Lam, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must be taking: ALK targeted therapy

Must not be taking: Cytotoxic chemotherapy, Immunotherapy, Steroids

Disqualifiers: Additional malignancy, CNS metastasis, Spinal cord compression, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety of a cancer peptide vaccine to prevent or delay acquired resistance in advanced ALK+ lung cancer patients currently on ALK targeted therapy.

Do I need to stop my current medications for the trial?

You can continue taking your current ALK targeted therapy medications like crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib while participating in the trial.

What data supports the effectiveness of the treatment for ALK+ lung cancer?

Research shows that a peptide vaccine can help the immune system recognize and attack ALK+ lung cancer cells, especially when combined with other treatments. In studies, this approach helped reduce lung tumors and prevent them from spreading to the brain. ^{1 2 3 4 5}

Is the peptide vaccine for ALK+ lung cancer safe for humans?

A review of clinical trials for non-small cell lung cancer vaccines, including peptide-based ones, shows they consistently demonstrate a lack of toxicity, indicating they are generally safe for humans. ^{1 2 3 6 7}

How is the Prophylactic Peptide Vaccine treatment different from other treatments for ALK+ lung cancer?

The Prophylactic Peptide Vaccine is unique because it specifically targets ALK+ lung cancer by stimulating the immune system to recognize and attack cancer cells, which is different from traditional treatments like ALK inhibitors that directly target cancer cell growth. This vaccine approach helps the immune system to better identify and destroy cancer cells, potentially preventing the spread of tumors. ^{1 2 3 8 9}

Research Team

Vincent Lam, M.D.

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adults over 18 with advanced ALK+ lung cancer who are responding to current ALK targeted therapy and have a good performance status. They must not have specific resistance alterations the vaccine targets, and their diagnosis should be confirmed by certain tests.

Inclusion Criteria

My lung cancer is at stage IV or has come back and cannot be treated with surgery or radiation.

I've been on ALK inhibitors for 4+ months with stable disease.

I am 18 years old or older.

Exclusion Criteria

I haven't had active treatment for another cancer within the last 3 years, except for certain skin cancers or cancers treated with the intent to cure.

I haven't had chemotherapy in the last 14 days or while on the study vaccine.

I haven't had cancer immunotherapy in the last 28 days.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the cancer peptide vaccine to prevent or delay acquired resistance in advanced ALK+ lung cancer

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Prophylactic Peptide Vaccine (Cancer Vaccine)

Trial Overview The study is testing a peptide vaccine's safety in preventing or delaying drug resistance in patients with advanced ALK+ lung cancer who are already on an ALK inhibitor treatment.

Participant Groups

Group I: Advanced ALK+ NSCLC Experimental Treatment 1 Intervention

All patients will receive the intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins University Baltimore, MD

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Patients Recruited

33,600+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ALK peptide vaccination restores the immunogenicity of ALK-rearranged non-small cell lung cancer. Mota, I., Patrucco, E., Mastini, C., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunoprevention of KRAS-driven lung adenocarcinoma by a multipeptide vaccine. Pan, J., Zhang, Q., Sei, S., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent progress in peptide vaccination in cancer with a focus on non-small-cell lung cancer. Talebian Yazdi, M., Keene, KR., Hiemstra, PS., et al.[2014]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Peptide-Based Vaccines for Cancer. Abd-Aziz, N., Poh, CL.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remarkable antitumor effect of nivolumab in a patient with metastatic renal cell carcinoma previously treated with a peptide-based vaccine. Kurahashi, R., Motoshima, T., Fukushima, Y., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influenza vaccination in patients with lung cancer receiving anti-programmed death receptor 1 immunotherapy does not induce immune-related adverse events. Wijn, DH., Groeneveld, GH., Vollaard, AM., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial watch: Peptide-based vaccines in anticancer therapy. Bezu, L., Kepp, O., Cerrato, G., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial Watch: Peptide-based anticancer vaccines. Pol, J., Bloy, N., Buqué, A., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

ALK peptide vaccination restores the immunogenicity of ALK-rearranged non-small cell lung cancer. [2023]

2. England pubmed.ncbi.nlm.nih.gov

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

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

Immunoprevention of KRAS-driven lung adenocarcinoma by a multipeptide vaccine. [2019]

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

Recent progress in peptide vaccination in cancer with a focus on non-small-cell lung cancer. [2014]

5. Egypt pubmed.ncbi.nlm.nih.gov

Development of Peptide-Based Vaccines for Cancer. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Remarkable antitumor effect of nivolumab in a patient with metastatic renal cell carcinoma previously treated with a peptide-based vaccine. [2022]

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

Influenza vaccination in patients with lung cancer receiving anti-programmed death receptor 1 immunotherapy does not induce immune-related adverse events. [2019]

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

Trial watch: Peptide-based vaccines in anticancer therapy. [2021]

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

Trial Watch: Peptide-based anticancer vaccines. [2021]