Ignite Creation Date:
2024-05-06 @ 2:57 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04470024
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2020-07-09
Brief Title:
Phase Ib Trial of Multivalent Autophagosome Vaccine With or Without GITR Agonist With Anti-PD-1 Immunotherapy in HNSCC
Sponsor:
Providence Health Services
Organization:
Providence Health Services
Study Overview
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
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None