Can a targeted drug shrink tumors when immunotherapy fails?
NCT ID NCT04375384
First seen Jun 26, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This phase 2 trial is testing the drug cetuximab by itself in people with head and neck cancer that has come back or spread. Participants have already tried immunotherapy (PD-1 inhibitors) and it stopped working or caused side effects. The study will measure how many patients see their tumors shrink and how long they live without the cancer getting worse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cetuximab (a targeted cancer drug given by IV)
- What this could lead to
- If it works, this could provide a new treatment option for patients with head and neck cancer whose disease has worsened after immunotherapy.
- What could go wrong
- This is a small, early-phase trial with only 38 participants, so results may not apply to everyone. Cetuximab can cause side effects like skin reactions and infusion reactions.
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 38 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2020
- 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.
- 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: * Patients must have histologically or cytologically confirmed head and neck squamous cell carcinoma. * Measurable disease by scans- at least one measurable lesion. * Patients must have received previous treatment with immunotherapy with PD-1 inhibitor alone or in combination with chemotherapy. * Patients must have a Performance Status of 0-2. * Patients must be greater than or equal to 18 years old. * Participant is willing and able to comply with the protocol for the duration of the study. * Ability to understand and the willingness to sign an Institutional Review Board-approved informed consent document. Exclusion Criteria: * Prior treatment with Cetuximab or prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway in the last five (5) years. * Prior allergic reaction to Cetuximab. * History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of Cetuximab. * Patients receiving any other investigational agents. * Patient is on medications that need to be continued and that might interact with Cetuximab. * Any uncontrolled condition, which in the opinion of the investigator, would interfere in the safe and timely completion of study treatment and procedures. * Participant with a history of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on screening chest imaging. Any of the following conditions: * Serious or non-healing wound, ulcer, or bone fracture at the discretion of treating physician * history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study enrollment * history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study enrollment * history of myocardial infarction, ventricular arrhythmia, stable/unstable angina, -symptomatic congestive heart failure, coronary/peripheral artery bypass graft or stenting or other significant cardiac disease within 6 months prior to study enrollment * history of arterial or venous thrombosis/thromboembolic event, including pulmonary embolism within 6 months of study enrollment * any condition requiring the use of immunosuppression, excluding rheumatologic conditions treated with stable doses of corticosteroids. Pregnancy, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment.
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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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Wake Forest Baptist Comprehensive Cancer Center
RECRUITINGWinston-Salem, North Carolina, 27157, United States
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Other studies related to the condition(s) this trial covers.
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- 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 a new drug combo slow advanced head and neck cancer?