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

NCT04470024 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Cancer of the Head and Neck

Interventions

DRUG

INCAGN01876

agonistic antihuman GITR mAb

DRUG

INCMGA00012

humanized, hinge-stabilized, IgG4κ mAb that recognized human PD-1

BIOLOGICAL

DPV-001

autophagosome cancer vaccine

Sponsors & Collaborators

  • Providence Health & Services

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-05
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04470024 on ClinicalTrials.gov