PBF-1129 + Nivolumab for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of a new drug combination, PBF-1129 (an adenosine A2B receptor antagonist) and nivolumab (also known as Opdivo), for individuals with non-small cell lung cancer that has recurred or spread. The goal is to determine the optimal dose and understand any side effects of this treatment duo. PBF-1129 and nivolumab aim to enhance the immune system's ability to fight cancer. Ideal candidates for this trial have already undergone standard chemotherapy and immunotherapy for their recurrent or metastatic lung cancer. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy or immunosuppressive drugs, you may need to stop them before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that PBF-1129, when tested alone, was well tolerated by patients with non-small cell lung cancer. Previous studies found no serious side effects at the doses tested, indicating that the treatment is generally safe.
Nivolumab, the other treatment in this trial, has already received approval for other conditions. Past studies reported safety outcomes similar to those observed in real-world use. Although some serious side effects occurred in a small number of patients, these were uncommon.
Overall, both treatments have demonstrated a good safety record in earlier studies, suggesting they are generally well-tolerated, though individual experiences may vary.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of PBF-1129 and nivolumab for lung cancer because it brings a fresh approach to treatment. Most lung cancer treatments focus on chemotherapy or targeted therapies, but PBF-1129 is unique as it targets the adenosine A2B receptor, which plays a role in suppressing the immune system's response to cancer. When combined with nivolumab, an immune checkpoint inhibitor that unleashes the immune system to attack cancer cells, this duo has the potential to enhance the immune system's ability to fight lung cancer more effectively. This novel combination could offer new hope for patients who haven't responded well to existing therapies.
What evidence suggests that this treatment might be an effective treatment for lung cancer?
Research shows that PBF-1129, one of the treatments in this trial, targets specific parts of cancer cells and has shown promise in slowing tumor growth in non-small cell lung cancer. Patients tolerated it well, experiencing no serious side effects. Studies also suggest it works effectively when combined with other treatments.
Nivolumab, the other treatment in this trial, has a strong history of treating non-small cell lung cancer. Research has shown that patients with advanced stages of this cancer lived longer when treated with nivolumab, with up to 42% of patients surviving after treatment. This trial will test the combination of PBF-1129 and Nivolumab, aiming to leverage the strengths of both to help the immune system fight cancer more effectively.26789Who Is on the Research Team?
Dwight Owen, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
Adults with recurrent or metastatic non-small cell lung cancer who have tried standard treatments, including chemotherapy and immunotherapy. They must have good organ function, no untreated brain metastases, no active infections like HIV/Hepatitis B or C, not be pregnant/breastfeeding, and willing to use contraception. Prior PD-1/PD-L1 therapy is required; prior CTLA4 therapy is okay.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PBF-1129 orally once daily and nivolumab intravenously on day 1 of each 28-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab
- PBF-1129
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
- Advanced or metastatic gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Esophageal squamous cell carcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dwight Owen
Lead Sponsor
National Cancer Institute (NCI)
Collaborator