Phase 1 Study of Pembrolizumab With A Vaccine for Metastatic NSCLC
Researchers are evaluating the safety and efficacy of pembrolizumab in combination with a synthetic long peptide vaccine among patients with non–small cell lung cancer.
Title: Pilot Feasibility Study of the Combination of a Personalized Therapeutic Anti-tumor Vaccine With Pembrolizumab in Non-Small Cell Lung Cancer1
Principal Investigators: Ramaswamy Govindan, MD, Washington University School of Medicine
Description: For this non-randomized phase 1 study, researchers are evaluating the safety and efficacy of pembrolizumab, a PD-1 inhibitor, in combination with a synthetic long peptide vaccine among patients with non–small cell lung cancer (NSCLC).
All included patients will have stage IV NSCLC stable after chemotherapy. The personalized vaccine will be developed after biopsy and will be administered several times throughout cycles 1 and 2 of pembrolizumab. All patients will receive pembrolizumab for up to 2 years.
The study's primary outcome is safety and feasibility; secondary outcomes include overall response rate, progression-free survival, and overall survival.
The estimated study enrollment is 20 patients.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT03166254.
Status: This study is open and recruiting patients as of November 29, 2017.
This study is sponsored by the Washington University School of Medicine.
- Clinicaltrials.gov. Combination of a personalized therapeutic anti-tumor vaccine with pembrolizumab in non-small cell lung cancer. NCT03166254. https://clinicaltrials.gov/ct2/show/NCT03166254. Accessed November 29, 2017.