CVHNLC + Pembrolizumab for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new mRNA vaccine (CVHNLC) combined with pembrolizumab, an immunotherapy, for treating metastatic Squamous Non-Small-Cell Lung Cancer (sqNSCLC). The main goal is to determine the safety and tolerability of the new treatment. Once safety is confirmed, the study will also evaluate its effectiveness alongside chemotherapy. Suitable candidates for this trial include those with metastatic sqNSCLC who have been receiving pembrolizumab as part of their treatment plan and require additional maintenance therapy without signs of cancer progression. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have received certain treatments recently, like steroids above a certain dose or other systemic immunosuppressive treatments. It's best to discuss your current medications with the trial team to be sure.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that the CV09070101 mRNA vaccine (CVHNLC) remains in the early testing phase, so information about its safety in people is limited. As this is its first test in humans, the main goal is to assess the vaccine's safety and tolerability. Previous research on similar mRNA vaccines for lung cancer suggests they are generally well-tolerated. Common side effects might include mild reactions like redness or pain at the injection site, while serious side effects are less common.
Pembrolizumab, the other treatment in this trial, is already an approved drug for lung cancer with a known safety record. Most patients tolerate it well, though some may experience side effects like tiredness or a rash. In rare cases, more serious effects can occur.
Overall, while the combination of CVHNLC and pembrolizumab is new and under study, the existing approval of pembrolizumab provides some reassurance about its safety. However, since CVHNLC is being tested for the first time, the trial will closely monitor for any unexpected reactions.12345Why do researchers think this study treatment might be promising for lung cancer?
Researchers are excited about the CV09070101 mRNA vaccine (CVHNLC) for lung cancer because it represents a new frontier in cancer treatment. Unlike traditional therapies that often involve chemotherapy or radiation, this mRNA vaccine is designed to stimulate the body's immune system to recognize and attack cancer cells more effectively. The CVHNLC vaccine works by delivering specific genetic instructions to cells, prompting them to produce proteins that trigger an immune response against the cancer. This novel approach not only aims to enhance the precision of the treatment but also potentially reduces side effects compared to conventional methods.
What evidence suggests that CVHNLC plus pembrolizumab could be an effective treatment for lung cancer?
Research has shown that mRNA vaccines can improve cancer treatment outcomes. Specifically, for lung cancer, combining mRNA vaccines with other treatments has led to longer survival times. Early data indicates that patients with non-small-cell lung cancer (NSCLC) who received mRNA vaccines lived longer when combined with immune checkpoint inhibitors. This trial studies the CV09070101 mRNA vaccine (CVHNLC) and its potential effectiveness with pembrolizumab, a well-known cancer drug. Together, they aim to strengthen the body's immune system to fight lung cancer more effectively.16789
Who Is on the Research Team?
Clinical Trial Information
Principal Investigator
CureVac SE
Are You a Good Fit for This Trial?
This trial is for patients with metastatic Squamous Non-Small-Cell Lung Cancer (sqNSCLC). Participants must be adults who can provide informed consent and are eligible based on specific health criteria not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive CVHNLC at escalating doses to determine safety and tolerability
Dose Expansion
Participants receive CVHNLC plus chemotherapy and pembrolizumab to further evaluate safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CV09070101 mRNA vaccine (CVHNLC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
CureVac
Lead Sponsor