12 Participants Needed

KRAS Vaccine + Immunotherapy for Lung Cancer

PF
KM
Overseen ByKristen Marrone, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special vaccine combined with immune-boosting substances and two drugs in advanced lung cancer patients with specific genetic mutations. The goal is to teach the immune system to attack the cancer cells more effectively.

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

The trial protocol does not specify if you need to stop taking your current medications. However, certain treatments like systemic corticosteroids, chemotherapy, and investigational drugs are not allowed shortly before starting the trial. It's best to discuss your specific medications with the trial team.

Is the KRAS vaccine combined with immunotherapy safe for humans?

The KRAS vaccine has been tested in mice and shown to be safe, with a strong immune response and minimal side effects. Additionally, a similar mRNA vaccine targeting KRAS mutations in humans was found to be safe, with no serious side effects reported in a small trial.12345

How is the KRAS Vaccine + Immunotherapy treatment for lung cancer different from other treatments?

This treatment is unique because it combines a vaccine targeting KRAS mutations with immunotherapy drugs (Ipilimumab and Nivolumab) to enhance the immune system's ability to fight lung cancer, specifically targeting a mutation that is often difficult to treat with existing therapies.13567

What data supports the effectiveness of the KRAS Vaccine + Immunotherapy treatment for lung cancer?

Research shows that a multipeptide KRAS vaccine significantly reduced tumor number and burden by over 80% in a mouse model of KRAS-driven lung cancer, indicating its potential effectiveness in preventing KRAS-driven cancers.13568

Who Is on the Research Team?

KM

Kristen Marrone, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Adults with advanced, inoperable KRAS-mutated non-small cell lung cancer (NSCLC) who haven't had prior treatment for this stage. Participants must have tumors that can be biopsied, good physical health (ECOG 0 or 1), and proper organ function. Women of childbearing age and sexually active men must agree to contraception use.

Inclusion Criteria

Women who could become pregnant must have a negative pregnancy test. If the test is positive or uncertain, an ultrasound must be done to confirm if the person is pregnant before joining the study.
My lung cancer is advanced and has not been treated yet.
My tumor has one of the six specific KRAS mutations.
See 10 more

Exclusion Criteria

I have been diagnosed with an immune system disorder.
I haven't had cancer or blood disorders in the last 5 years, except for certain low-risk types.
My brain metastases are treated, I'm symptom-free, and it's been 2 weeks since my last therapy.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the KRAS peptide vaccine with poly-ICLC adjuvant in combination with nivolumab and ipilimumab

Up to 29 days
Multiple visits for administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years

Long-term monitoring

Participants are monitored for progression free survival and T cell response

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Ipilimumab
  • Nivolumab
  • Pooled Mutant KRAS-Targeted Long Peptide Vaccine
Trial Overview The trial is testing a new vaccine targeting specific KRAS mutations in NSCLC combined with the immune checkpoint inhibitors nivolumab and ipilimumab. It aims to assess safety, feasibility, and how well it prevents disease progression.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Patients With NSCLCExperimental Treatment1 Intervention

Ipilimumab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Yervoy for:
🇪🇺
Approved in European Union as Yervoy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials
578
Recruited
33,600+

Published Research Related to This Trial

The multi-peptide vaccine Emut Vax effectively prevented the development of lung tumors driven by common EGFR mutations in mouse models, indicating its potential as a preventive treatment for EGFR mutation-positive lung cancer.
Emut Vax not only enhanced Th1 immune responses in the tumor microenvironment but also reduced the number of suppressive T regulatory cells, suggesting a robust immune modulation that could improve anti-tumor efficacy.
Precision immunointerception of EGFR-driven tumorigenesis for lung cancer prevention.Pan, J., Xiong, D., Zhang, Q., et al.[2023]
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.
A review of vaccine clinical trials for non-small cell lung cancer.Nemunaitis, J., Nemunaitis, J.[2019]
The multipeptide vaccine targeting KRAS mutations demonstrated over 80% reduction in tumor number and burden in a mouse model, indicating strong antitumor efficacy before the mutant KRAS protein was activated.
The vaccine elicited a robust immune response characterized by Th1 cytokine secretion, suggesting it could be an effective preventive strategy against KRAS-driven lung cancer and potentially other cancers.
Immunoprevention of KRAS-driven lung adenocarcinoma by a multipeptide vaccine.Pan, J., Zhang, Q., Sei, S., et al.[2019]

Citations

Precision immunointerception of EGFR-driven tumorigenesis for lung cancer prevention. [2023]
A review of vaccine clinical trials for non-small cell lung cancer. [2019]
Immunoprevention of KRAS-driven lung adenocarcinoma by a multipeptide vaccine. [2019]
Immunogenicity of Del19 EGFR mutations in Chinese patients affected by lung adenocarcinoma. [2020]
In silico-guided sequence modifications of K-ras epitopes improve immunological outcome against G12V and G13D mutant KRAS antigens. [2022]
Efficacy of immunotherapy targeting the neoantigen derived from epidermal growth factor receptor T790M/C797S mutation in non-small cell lung cancer. [2022]
mRNA vaccine-induced neoantigen-specific T cell immunity in patients with gastrointestinal cancer. [2021]
Potentiation of Kras peptide cancer vaccine by avasimibe, a cholesterol modulator. [2021]
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