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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Providence Health & Services
Study ID
NCT04470024
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cancer of the Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INCAGN01876 — DRUG
    agonistic antihuman GITR mAb
  • INCMGA00012 — DRUG
    humanized, hinge-stabilized, IgG4κ mAb that recognized human PD-1
  • DPV-001 — BIOLOGICAL
    autophagosome cancer vaccine

Study Details

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.

Key Dates

Start date
Aug 5, 2021
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Vax + delayed anti-PD-1
  • Experimental: Arm 2 (CLOSED TO ENROLLMENT)
    Vax + anti-GITR + delayed anti-PD-1

Primary Outcome Measure

Adverse Events Assessment [ Time Frame: from time of informed consent through 90 days after the last study treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Portland Providence Medical CenterPortlandOregon97213
George Morris
[email protected]
503-215-7503
Rom Leidner, MD (PRINCIPAL_INVESTIGATOR)

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Portland Providence Medical Center· Portland, OR

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