Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer
Recruiting
Phase 2Interventional Study
Head and Neck Squamous Cell CarcinomaRecurrent Head and Neck Squamous Cell CarcinomaMetastatic Head-and-neck Squamous-cell Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
38 (estimated)
Sponsor
Wake Forest University Health Sciences · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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 wi…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.