Small-cell Lung Cancer: A Phase 2 Study of p53 Vaccination With Checkpoint Inhibition

Title: Combination Immunotherapy With Ipilimumab and Nivolumab Plus a Dendritic Cell Based p53 Vaccine (Ad.p53-DC) in Patients With Relapsed Small Cell Lung Cancer (SCLC)¹

Principal Investigators: Alberto Chiappori, MD, H. Lee Moffitt Cancer Center and Research Institute

Description: For this single-group assignment phase 2 study (ClinicalTrials.gov Identifier: NCT03406715), researchers are evaluating whether adding a dendritic cell–based p53 vaccine to nivolumab and ipilimumab combination checkpoint inhibition will improve outcomes among patients with recurrent SCLC.

Patients will receive induction nivolumab and ipilimumab on the first day of 4 21-day cycles. The p53 vaccine will be administered 3 times during induction therapy. Nivolumab monotherapy will then be administered during a maintenance phase; patients will also receive the vaccine 3 times during maintenance.

The p53 vaccine will be produced in a laboratory post-leukapheresis.

The primary outcome is disease-control rate; secondary outcomes include progression-free survival, overall survival, and overall response rate.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT03406715.

Status: This study is not yet open to patient recruitment. The anticipated study start date is March 2018.

This study is sponsored by the H. Lee Moffitt Cancer Center and Research Institute.

Reference

1. Clinicaltrials.gov. Combination immunotherapy-ipilimumab-nivolumab-dendritic cell p53 vac – patients with small cell lung cancer (SCLC). NCT03406715. https://clinicaltrials.gov/ct2/show/NCT03406715. Accessed January 24, 2018.