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).

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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.

Reference

  1. 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.

Topics:

Lung Cancer Non-Small Cell Lung Cancer