Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer

NCT ID: NCT04375384

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2027-12-31

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.

Conditions

Head and Neck Squamous Cell Carcinoma; Recurrent Head and Neck Squamous Cell Carcinoma; Metastatic Head-and-neck Squamous-cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cetuximab

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

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: DRUG

A loading dose of Cetuximab will be administered intravenously in the first day of treatment. The dose is 400 mg/m2 and will be infused over 2h followed by 1h observation.

The maintenance dose of Cetuximab is 250 mg/m2 and will be infused over 1h. No further observation time needed.

The maintenance dose of cetuximab will be given every 7 days (+/- 2 days) starting 7 days (+/- 2 days) after the loading dose of cetuximab.

Pre-medicate with 50 mg Diphenhydramine IV before the loading dose of Cetuximab and as per standard of care before the maintenance treatment.

Questionnaire administration

Intervention Type: OTHER

Ancillary studies

Quality of life assessment

Intervention Type: OTHER

Ancillary studies

Interventions

Cetuximab

A loading dose of Cetuximab will be administered intravenously in the first day of treatment. The dose is 400 mg/m2 and will be infused over 2h followed by 1h observation.

The maintenance dose of Cetuximab is 250 mg/m2 and will be infused over 1h. No further observation time needed.

The maintenance dose of cetuximab will be given every 7 days (+/- 2 days) starting 7 days (+/- 2 days) after the loading dose of cetuximab.

Pre-medicate with 50 mg Diphenhydramine IV before the loading dose of Cetuximab and as per standard of care before the maintenance treatment.

Intervention Type: DRUG

Questionnaire administration

Ancillary studies

Intervention Type: OTHER

Quality of life assessment

Ancillary studies

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mercedes Porosnicu, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Study Nurse

Role: CONTACT

saverill@wakehealth.edu

336-713-7748

Facility Contacts

Study Nurse

Role: primary

saverill@wakehealth.edu

References

Burcher KM, Bloomer CH, Gavrila E, Kalada JM, Chang MJ, Gebeyehu RR, Song AH, Khoury LM, Lycan TW, Kinney R, D'Agostino R Jr, Bunch PM, Shukla K, Triozzi P, Furdui CM, Zhang W, Porosnicu M. Study protocol: phase II study to evaluate the effect of cetuximab monotherapy after immunotherapy with PD-1 inhibitors in patients with head and neck squamous cell cancer. Ther Adv Med Oncol. 2024 Jan 19;16:17588359231217959. doi: 10.1177/17588359231217959. eCollection 2024.

Reference Type: DERIVED

PMID: 38249330 (View on PubMed)

Other Identifiers

WFBCCC 60220

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00065239

Identifier Type: -

Identifier Source: org_study_id