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NCT04065555 · ClinicalTrials.gov registry record · Early Phase 1
Intratumoral Microdosing of TAK-981 in Head and Neck Cancer
A Early Phase 1 study of Head and Neck Cancer, sponsored by Presage Biosciences.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
- 6
- Study locations
NCT04065555: Completed Early Phase 1 study of Head and Neck Cancer, sponsored by Presage Biosciences.
NCT04065555 is a Early Phase 1 study of Head and Neck Cancer that has completed, run by Presage Biosciences. The registered enrollment target is 12 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (95% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04065555, a Early Phase 1 study of Head and Neck Cancer, has completed, sponsored by Presage Biosciences.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
- 6
- Study locations
Study Summary
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.
Primary Outcome
Quantification of biomarker-positive and biomarker-negative cells will be performed within the tumor microenvironment around each of the injection sites of each resected patient sample by IHC and ISH. An aggregate analysis of this quantification may be done across patient samples to evaluate trends in tumor response. List of biomarkers evaluated may include biomarkers for cell death (e.g. cleaved caspase 3), T-cells (e.g. CD3, CD8/Granzyme B), and natural killer (NK) or myeloid cells (e.g. CD56/
Conditions Studied
Interventions
- BIOLOGICAL Cetuximab
- BIOLOGICAL Avelumab
- DRUG TAK-981
- COMBINATION_PRODUCT TAK-981 + Cetuximab
- COMBINATION_PRODUCT TAK-981 + Avelumab
Study Locations (6)
New York
- Northwell Health (Lenox Hill) - New York
- Northwell Health (Monter Cancer Center) - North New Hyde Park
Oregon
- Oregon Health & Science University (OHSU) - Portland
- Portland VA - Portland
Michigan
- University of Michigan - Ann Arbor
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-10-07 |
| Est. Completion | 2022-07-20 |
| Phase | Early Phase 1 |
What the finished NCT04065555 record still lists
NCT04065555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 5 interventions - of which Cetuximab is the first listed.
NCT04065555 lists 6 locations in 4 states (New York, Oregon, Michigan).
Frequently Asked Questions
What is clinical trial NCT04065555 about?
NCT04065555 is a clinical study titled "Intratumoral Microdosing of TAK-981 in Head and Neck Cancer". 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 quantitie...
What is the current status of trial NCT04065555?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2020-10-07. Estimated completion is 2022-07-20.
What conditions does trial NCT04065555 study?
This clinical trial studies the following conditions: Head and Neck Cancer.
What interventions are being tested in trial NCT04065555?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Avelumab (BIOLOGICAL), TAK-981 (DRUG), TAK-981 + Cetuximab (COMBINATION_PRODUCT), TAK-981 + Avelumab (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04065555?
This trial is sponsored by Presage Biosciences, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04065555 being conducted?
This trial has 6 study locations across Michigan, New York, Oregon, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04065555's enrollment target sits among peer trials
12 232nd of 250 higher than 15 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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