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NCT03544723

A Phase 2, Multi-Center, Open Label Study to Evaluate Adenoviral p53 (Ad-p53) in Combination With Immune Checkpoint Inhibitor Therapy in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Tumors Approved for Anti-PD-1 or Anti-PD-L1 Therapy

Study Summary

This is a single arm Phase 2 study of the combination of adenoviral p53 (Ad-p53) gene therapy administered intra-tumorally with approved immune checkpoint inhibitors in patients with recurrent or metastatic cancers. Comparison will be made to historical data. General safety and efficacy using RECIST 1.1 and Immune-Related Response Criteria as well as ECOG performance will be utilized.

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Interventions

Ad-p53DRUG
Antineoplastic, Monoclonal Antibody; PD-1/PD-L1 Inhibitors. Immunotherapy. Gene Therapy.

Study Locations

FacilityCityStateCountry
Robert H. Lurie Comprehensive Cancer Center | Northwestern UniversityChicagoIllinoisUnited States
Rush University Cancer CenterChicagoIllinoisUnited States
Morristown Medical CenterMorristownNew JerseyUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026