CIMAvax Vaccine + Nivolumab + Pembrolizumab for Non-small Cell Lung Cancer and Squamous Head and Neck Cancer
Trial Summary
What is the purpose of this trial?
This trial is testing a combination of a cancer vaccine (CIMAvax) and immune-boosting drugs (nivolumab and pembrolizumab). CIMAvax has shown promising results in lung cancer patients, while nivolumab and pembrolizumab have significantly improved overall survival in various cancers. It targets patients with advanced lung and head/neck cancers that have spread. The treatment works by enhancing the immune system's ability to fight cancer.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot have received anticancer chemotherapy within 4 weeks before the first administration of the study drug, and you should not be on systemic corticosteroids or immunosuppressive drugs within 4 weeks prior to starting the study drug, unless they are for hormone replacement or short-course supportive medication. It's best to discuss your specific medications with the trial team.
What data supports the idea that CIMAvax Vaccine + Nivolumab + Pembrolizumab for Non-small Cell Lung Cancer and Squamous Head and Neck Cancer is an effective treatment?
The available research shows that treatments involving nivolumab and pembrolizumab, which are part of the combination with CIMAvax Vaccine, have shown promising results in treating head and neck squamous cell carcinoma. For example, a systematic review found that these drugs had a favorable response rate of about 45.9% in patients with head and neck cancer, with no unexpected severe side effects. This suggests that the combination treatment could be effective for these types of cancers.12345
What safety data exists for the combination of CIMAvax, Nivolumab, and Pembrolizumab in treating cancer?
The safety data for Nivolumab and Pembrolizumab, both anti-PD-1 monoclonal antibodies, indicate they are associated with distinct immune-related adverse effects. A systematic review and meta-analysis of randomized clinical trials have summarized the toxicity profiles of these agents. Additionally, a phase II trial of Pembrolizumab in non-small cell lung cancer reported interim safety results. However, specific safety data for the combination with CIMAvax is not detailed in the provided research.678910
Is the CIMAvax Vaccine combined with the drugs Nivolumab and Pembrolizumab a promising treatment for non-small cell lung cancer and squamous head and neck cancer?
Yes, the combination of CIMAvax Vaccine with the drugs Nivolumab and Pembrolizumab is promising. Nivolumab and Pembrolizumab are known to boost the immune system to fight cancer, and the CIMAvax Vaccine may enhance their effectiveness. This combination has shown potential in improving survival rates for certain cancers.35111213
Research Team
Prantesh Jain, MD
Principal Investigator
Roswell Park Cancer Institute
Eligibility Criteria
This trial is for adults with advanced non-small cell lung cancer or squamous head and neck cancer. Participants must have a life expectancy of at least 6 months, normal organ function, no recent chemotherapy, untreated brain metastases, or major surgery. They should not be pregnant and agree to use contraception. Those with certain autoimmune diseases or previous immunotherapy (with some exceptions) are excluded.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- CIMAvax Vaccine (Cancer Vaccine)
- Nivolumab (Monoclonal Antibodies)
- Pembrolizumab (Monoclonal Antibodies)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Roswell Park Cancer Institute
Lead Sponsor