NEO-201 + Pembrolizumab for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new drug called NEO-201 with an existing drug, pembrolizumab, in patients with certain types of cancer that haven't responded to initial treatments. NEO-201 helps the immune system target cancer cells, while pembrolizumab boosts the immune response against cancer. Pembrolizumab has demonstrated activity in various cancers, including melanoma, non-small cell lung cancer, and renal cell carcinoma.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, there are specific waiting periods after certain treatments, like 14 days after oral tyrosine kinase inhibitors and 21 days after monoclonal antibodies, before you can join the trial.
Is the combination of NEO-201 and Pembrolizumab safe for humans?
Pembrolizumab, also known as Keytruda, has been used in various cancer treatments and is generally considered safer than traditional chemotherapy, but it can cause side effects like pneumonitis (lung inflammation) in 1%-5% of patients and rare cases of type 1 diabetes. There is no specific safety data available for NEO-201 in combination with Pembrolizumab, but Pembrolizumab alone has been studied extensively.12345
What makes the drug NEO-201 + Pembrolizumab unique for non-small cell lung cancer?
The combination of NEO-201 and Pembrolizumab is unique because it pairs a novel treatment (NEO-201) with Pembrolizumab, a well-established immunotherapy that blocks PD-1, a protein that helps cancer cells evade the immune system. This combination aims to enhance the immune response against cancer cells, potentially offering a new approach for patients with non-small cell lung cancer.16789
What data supports the effectiveness of the drug NEO-201 + Pembrolizumab for Non-Small Cell Lung Cancer?
Research shows that pembrolizumab, one of the drugs in the treatment, has been effective in treating non-small cell lung cancer, leading to significant survival outcomes and long-lasting responses. It is approved for advanced cases and has shown promising results in improving patient prognosis.1691011
Who Is on the Research Team?
Kevin Conlon, MD
Principal Investigator
National Cancer Institute - Women's Malignancy Branch
Charalampos Floudas, MD
Principal Investigator
National Cancer Institute - Head and Neck/GUMB
Azam Ghafoor, MD
Principal Investigator
National Cancer Institute - Thoracic and GI Malignancy Branch
Are You a Good Fit for This Trial?
Adults with certain advanced cancers (lung, head and neck, cervical, uterine) that worsened after standard treatment can join. They need a biopsy sample available or agree to a new biopsy. Participants must be at least 18 years old, not pregnant or breastfeeding, use birth control if applicable, have no severe illnesses or brain metastases under control without seizures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Lead-in
A safety lead-in will be conducted in the first 3 to 6 subjects to evaluate toxicity prior to expanding accrual. The safety lead-in will be 42 days in length, consisting of 1 dose of pembrolizumab and 3 doses of NEO-201 followed by a 2-week assessment for safety.
Expansion Phase
Subjects with NSCLC, HNSCC, cervical and uterine cancers will be treated with NEO-201 at the RP2D (1.5 mg/kg) every 2 weeks in combination with pembrolizumab, given 1 day after the NEO-201, at 400 mg IV every 6 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NEO-201
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Precision Biologics, Inc
Lead Sponsor