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Completed Early Phase 1 Interventional

Intratumoral Microdosing of TAK-981 in Head and Neck Cancer

ClinicalTrials.gov ID: NCT04065555

Public ClinicalTrials.gov record NCT04065555. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 7:40 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Evaluation of TAK-981 and TAK-981 Combinations Following Intratumoral CIVO® Microdosing in Patients With Head and Neck Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a multi-center, single arm, open-label, multi-agent, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of TAK-981 and TAK-981 combined with cetuximab or avelumab when administered intratumorally in microdose quantities via the CIVO device. CIVO stands for comparative in vivo oncology.

Study identification

NCT ID
NCT04065555
Recruitment status
Completed
Study type
Interventional
Phase
Early Phase 1
Lead sponsor
Presage Biosciences
Industry
Enrollment
12 participants

Conditions and interventions

Interventions

Drug · Biological · Combination Product

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 7, 2020 (Actual)
Primary completion
Jun 20, 2022 (Actual)
Completion
Jul 20, 2022 (Actual)
Last update posted
Jul 29, 2022

2020 – 2022

United States locations

U.S. sites
6
U.S. states
4
U.S. cities
5
Facility City State ZIP Site status
University of Michigan Ann Arbor Michigan 48109 —
Northwell Health (Lenox Hill) New York New York 10075 —
Northwell Health (Monter Cancer Center) North New Hyde Park New York 11042 —
Oregon Health & Science University (OHSU) Portland Oregon 97239 —
Portland VA Portland Oregon 97239 —
University of Washington Seattle Washington 98109 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04065555, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 29, 2022 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04065555 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →