Phase Ib Trial of Multivalent Autophagosome Vaccine With or Without GITR Agonist, With Anti-PD-1 Immunotherapy in HNSCC

Cancer of the Head and Neck Clinical Trial

Official title: A Phase Ib Study of Multivalent Autophagosome Vaccine, With or Without GITR Agonist, With Sequenced Checkpoint Inhibition (Anti-PD-1) - Immunotherapy Trio in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Status Recruiting

Clinical Trial Summary

This is a phase Ib study with a safety lead-in (n = 6 per arm) evaluating combinatorial DPV-001 + sequenced PD-1 blockade, with or without GITR agonist, in recurrent or metastatic HNSCC.

Clinical Trial Description

This is a phase Ib trial of an autophagosome vaccine (DPV-001) with or without anti-GITR (INCAGN01876), combined with subsequent anti-PD1 (INCMGA00012), in patients with recurrent or metastatic HNSCC. Eligible patients will be registered and assigned to one of two treatment arms. Subjects in Arm 1 will receive combination therapy with DPV-001 with delayed anti-PD-1, and subjects in Arm 2 will receive DPV-001 and anti-GITR with delayed anti-PD-1 (triplet therapy). Mandatory biopsy will occur at week 2. Initial restaging CT and mandatory biopsy will occur at 8 weeks, followed by confirmatory CT at 12 weeks. Subsequent restaging CT will be performed at week 24 and every 12 weeks thereafter. Starting at week 22, dosing of DPV-101 will switch to a q4wk schedule, while the schedule of anti-GITR and anti-PD1 will remain unchanged. ;

Related Conditions & MeSH terms

• Cancer of the Head and Neck
• Head and Neck Neoplasms

• NCT number: NCT04470024
• Study type: Interventional
• Source: Providence Health & Services
• Contact: George Morris
• Phone: 503-215-7503
• Email: george.morris@providence.org
• Status: Recruiting
• Phase: Phase 1
• Start date: August 5, 2021
• Completion date: December 31, 2027