500 cancer patients join quest to unlock hidden clues in their blood and tumors
NCT ID NCT06163534
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This study enrolls 500 adults with advanced head and neck cancer who are starting standard immunotherapy. Researchers will collect blood and tumor samples over time to look for genetic and immune markers that may predict how well treatment works or why it stops working. The goal is to gather information to improve future treatments, not to test a new drug.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This protocol targets patients with metastatic or unresectable, recurrent HNSCC intended for first line immunotherapy or combination therapy.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * ≥18 years of age * Willing and able to provide informed consent * Histologically- or cytologically-confirmed metastatic or unresectable, recurrent HNSCC unsuitable for local therapies * Intended for first line anti-PD1 or PDL1 monotherapy or combination therapy * Must submit tumor tissue sample representative of current disease per laboratory manual Exclusion Criteria: * Non-squamous histologies (eg, nasopharynx or salivary gland) * Relapse or recurrence within 6 months of first line chemotherapy and / or chemoradiotherapy * Tumors that are PD-L1 negative (CPS \<1) * Clinical evidence of an active second invasive malignancy within \<2 years of enrollment with the exception of stable prostate cancer on watchful waiting, in situ cervical cancer, in situ breast carcinoma or localized non-melanoma skin cancers * Unable to comply with study procedures (i.e., not willing or able to have additional blood samples collected)
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Head and neck squamous cell carcinoma are added.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
31 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cancer Care Associates of York
RECRUITINGYork, Pennsylvania, 17403, United States
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Cancer Care Specialists of Illinois
RECRUITINGDecatur, Illinois, 62526, United States
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City of Hope
RECRUITINGDuarte, California, 91010, United States
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Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195, United States
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Dana Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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Henry Ford
RECRUITINGDetriot, Michigan, 48202, United States
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Illinois Cancer Care
RECRUITINGPeoria, Illinois, 61615, United States
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Karmanos Cancer Institute
RECRUITINGDetroit, Michigan, 48201, United States
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Mayo Clinic Florida
RECRUITINGJacksonville, Florida, 32224, United States
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Mayo Clinic Rochester
RECRUITINGRochester, Minnesota, 55905, United States
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Morehouse
RECRUITINGAtlanta, Georgia, 30310, United States
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Mount Sinai Hospital
RECRUITINGNew York, New York, 10029, United States
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Northwestern University Feinberg School of Medicine
RECRUITINGChicago, Illinois, 60611, United States
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Ohio State University
RECRUITINGColumbus, Ohio, 43210, United States
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Oncology Hematology Associates
RECRUITINGSpringfield, Missouri, 65807, United States
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Pan American Cancer for Oncology
ACTIVE_NOT_RECRUITINGSan Juan, 00909, Puerto Rico
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Piedmont Healthcare
RECRUITINGAtlanta, Georgia, 30318, United States
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Providence Medical Foundation
RECRUITINGSanta Rosa, California, 95403, United States
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Sanford Fargo
RECRUITINGFargo, North Dakota, 58102, United States
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Sanford Sioux Falls
RECRUITINGSioux Falls, South Dakota, 57104, United States
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Stanford
RECRUITINGPalo Alto, California, 94304, United States
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ThedaCare
RECRUITINGAppleton, Wisconsin, 54911, United States
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USC/Norris Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90033, United States
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University of California, Los Angeles
RECRUITINGLos Angeles, California, 90095, United States
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University of Cincinnati
RECRUITINGCincinnati, Ohio, 45219, United States
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University of Kansas
RECRUITINGWestwood, Kansas, 66205, United States
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University of Maryland
RECRUITINGBaltimore, Maryland, 21202, United States
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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University of Washington
RECRUITINGSeattle, Washington, 98109, United States
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Vanderbilt University
RECRUITINGNashville, Tennessee, 37212, United States
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Washington University in St. Louis
RECRUITINGSt Louis, Missouri, 63130, United States
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Winship Cancer Institute, Emory University
RECRUITINGAtlanta, Georgia, 30322, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New PET tracer aims to light up hidden cancer targets
- Can immunotherapy before surgery stop early oral cancer from returning?
- Can a glowing dye show surgeons where head and neck tumors end?
- Can a Four-Part combo before surgery wipe out head and neck tumors?
- Can a new drug shrink advanced solid tumors?
- Can steroid shots shield salivary glands from radiation damage?