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

NCT04375384 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: IRB00065239WFBCCC 60220P30CA012197
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Overall Response Rate To Treatment with Cetuximab

  Overall response rate is defined as the proportion patients achieving partial response or complete response per RECIST v1.1 criteria. An estimate of a 95% Exact Clopper Pearson confidence interval will be used. RECIST 1.1 criteria will be used to measure tumor size: Measurable disease is defined by the presence of at least 1 measurable lesion. A lesion, not previously irradiated per the protocol prior to enrollment, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) with CT or MRI and that is suitable for accurate repeated measurements. Non-measurable: All other lesions, including small lesions (longest diameter \<10 mm or pathological lymph nodes with ≥10 mm to \<15 mm short axis at baseline). Only participants with measurable disease at baseline will be included in the study.

  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 (4)

• Duration of Progression Free Survival

  At 6 months and at 1 year after enrollment on study

• Duration of Overall Survival

  At 6 months and at 1 year after enrollment on study

• Duration of Response

  At 6 months and at 1 year after enrollment on study

• Number of Treatment-Related Toxicities with Cetuximab as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  Up to 2 years

Study Arms (1)

Cetuximab

EXPERIMENTAL

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

Drug: Cetuximab; Other: Questionnaire administration; Other: Quality of life assessment

Interventions

Cetuximab 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.

Cetuximab

Questionnaire administration OTHER

Ancillary studies

Cetuximab

Quality of life assessment OTHER

Ancillary studies

Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 38249330 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mercedes Porosnicu, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

3367165772; Holly.Maize@Advocatehealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 5, 2020
• Study Start: July 1, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)