RecruitingPhase 1NCT04470024

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

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)


Sponsor

Providence Health & Services

Enrollment

56 participants

Start Date

Aug 5, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a novel vaccine-based treatment combined with immunotherapy (anti-PD-1) for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) — cancers affecting the throat, mouth, or voice box that have come back or spread. The vaccine is designed to stimulate the immune system to attack the cancer. **You may be eligible if:** - You have confirmed recurrent or metastatic head and neck squamous cell carcinoma - You are 18 or older - Your general health score (ECOG) is 0-2 - Your blood counts, kidney, and liver function meet required levels - If you have Hepatitis B, C, or HIV, your viral levels must be well-controlled **You may NOT be eligible if:** - You have active autoimmune disease requiring treatment - You are pregnant or breastfeeding - You have active, untreated brain metastases - You have severe organ failure (liver, kidneys, heart) - You are not expected to survive more than 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGINCAGN01876

agonistic antihuman GITR mAb

DRUGINCMGA00012

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

BIOLOGICALDPV-001

autophagosome cancer vaccine


Locations(1)

Portland Providence Medical Center

Portland, Oregon, United States

View Full Details on ClinicalTrials.gov

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NCT04470024


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