Can a PET scan predict if immunotherapy works? new study aims to find out
NCT ID NCT07448727
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether a special PET scan taken 6 weeks after starting pembrolizumab (an immunotherapy drug) can predict how well the drug works at 3, 6, and 9 months in people with advanced head and neck cancer. Researchers will enroll 25 patients whose cancer has returned or spread and who have a specific marker (PD-L1 CPS >1). The goal is to see if early changes in tumor activity on the scan can guide treatment decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pembrolizumab
- What this could lead to
- If successful, this could help doctors know sooner whether pembrolizumab is working, allowing them to adjust treatment earlier.
- What could go wrong
- This is a small, early observational study (25 people) that only looks at scans, not a new treatment. It may not lead to changes in care.
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 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
recurrent and/or metastatic HNSCC candidate for ICI-based first-line treatment
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histological diagnosis of recurrent and/or metastatic HNSCC, not amenable for curative locoregional treatment (either surgery or radiotherapy), and amenable for first line systemic treatment * CPS PD-L1 \>=1 Exclusion Criteria: * Any controindication to immune checkpoint inhibitors
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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
1 site. 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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Tor Vergata University Hospital
RECRUITINGRome, Italy, 00133, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radiation plus targeted antibody tested in older head and neck cancer patients
- Can a guided missile for chemo hit tumors harder and spare healthy tissue?
- Can a new drug shrink tumors that resist standard care?
- Cutting radiation after surgery: a new hope for head and neck cancer patients?
- Can a new drug combo revive Immunotherapy's power against resistant tumors?
- Can an immunotherapy combo shrink throat tumors before surgery?