Clinical trial NCT04375384: Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer
Official title: Pilot Phase II Study to Evaluate Effect of Cetuximab Given as Single Agent After Immunotherapy With PD-1 Inhibitors in Patients With Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma
Metastatic Head-and-neck Squamous-cell Carcinoma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-05-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Primary Objective:

• To measure Overall Response Rate to treatment with Cetuximab as single agent in patients with recurrent or metastatic head and neck squamous cell cancer who failed PD-1 inhibitors alone or in combination with chemotherapy.

Secondary Objective(s):

* Measure Duration of Response (DUR), Progression Free Survival and Overall Survival and for treatment with single agent Cetuximab after immunotherapy with PD-1 inhibitors in Head and Neck Squamous Cell Carcinoma.
* Evaluate treatment toxicity with single agent Cetuximab in this patient population.

OUTLINE: Patients receive cetuximab intravenously (IV) over 60-120 minutes once every week in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 week and then every 6-8 weeks thereafter.

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 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) days.
* 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.

Primary outcomes:
measure: Change in Overall Response Rate To Treatment with Cetuximab
timeFrame: 14 days before start of treatment, 7 weeks after start of treatment, and then every 6-8 weeks for the duration of treatment, up to approximately 2 years.
Secondary outcomes:
measure: Duration of Progression Free Survival
timeFrame: At 6 months and at 1 year after enrollment on study
measure: Duration of Overall Survival
timeFrame: At 6 months and at 1 year after enrollment on study
measure: Duration of Response
timeFrame: At 6 months and at 1 year after enrollment on study
measure: Number of Treatment-Related Toxicities with Cetuximab as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Mercedes Porosnicu, MD
role: PRINCIPAL_INVESTIGATOR
References: