Can a migraine drug make oral cancer treatment hit harder?
NCT ID NCT07812467
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Researchers are testing whether adding rimegepant to standard chemoimmunotherapy before surgery helps shrink oral or oropharyngeal squamous cell carcinoma more effectively. The trial enrolls adults with primary or recurrent disease who are scheduled for surgery. Participants receive two cycles of chemoimmunotherapy with or without rimegepant, and researchers measure how much viable tumor remains in the removed tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rimegepant, a drug that blocks the CGRP receptor, added to standard chemotherapy and immunotherapy
- What this could lead to
- If adding rimegepant helps, it could become a new way to boost chemoimmunotherapy before surgery for oral and oropharyngeal cancers.
- What could go wrong
- This is a phase II trial, so it cannot prove the combination works better than standard treatment. Rimegepant may not improve tumor response, and adding it could cause unexpected side effects.
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.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 220 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2033
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.
- Ages
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18 to 75 years
- 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: * Age 18 to 75 years, regardless of sex. * Histologically or cytologically confirmed oral or oropharyngeal squamous cell carcinoma, including primary disease or recurrent disease after previous treatment that is considered amenable to repeat curative-intent resection. * Planned to receive neoadjuvant chemoimmunotherapy followed by surgery after multidisciplinary evaluation. * At least one evaluable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1. * Eastern Cooperative Oncology Group performance status of 0 or 1. * Adequate major organ function. * Voluntary participation and provision of written informed consent. Exclusion Criteria: * Severe cardiac, hepatic, or renal dysfunction. * Active autoimmune disease. * Pregnancy or breastfeeding. * Known allergy or hypersensitivity to rimegepant or any component of the planned neoadjuvant treatment. * Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
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Get notified about this study
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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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Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can immunotherapy before surgery stop early oral cancer from returning?
- MRI scans may reveal which throat cancer patients need stronger treatment
- Can a glowing mouthwash spot oral cancer before biopsy?
- Could a Cell-Cycle protein reveal how aggressive oral cancer is?
- Can a Two-Drug punch shrink oral tumors before surgery?
- Could a simple test spot oral cancer and gum disease early?