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New treatment option for Head and Neck Squamous Cell Carcinoma
Official title Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer
ClinicalTrials.gov ID: NCT04375384
What this study is testing
What is Cetuximab?
Cetuximab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for head and neck squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase II treatment, non-randomized, open label clinical trial to study the efficacy of the Cetuximab when administered as single agent in recurrent/ metastatic head and neck squamous cell carcinoma after the failure or intolerance of immuno-oncology or immuno-oncology combined with chemotherapy.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Prior treatment with Cetuximab or prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway in the...
- 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...
See the full eligibility 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winston-Salem, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.