What is the mechanism of action of this treatment?

The most common treatments for Squamous Cell Carcinoma (SCC) include targeted therapies like cetuximab, which is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR). Cetuximab binds to EGFR on cancer cells, blocking growth signals and potentially reducing tumor size. It also enhances the immune system's ability to attack cancer cells through antibody-dependent cellular cytotoxicity (ADCC). These mechanisms are important for SCC patients as they offer a targeted approach to control aggressive tumor growth and improve surgical outcomes.

What side effects are associated with this type of intervention?

Common treatments for Squamous Cell Carcinoma (SCC), particularly those involving Cetuximab, a monoclonal antibody targeting EGFR, are associated with several side effects. These include skin rash, febrile neutropenia, diarrhea, and infusion-related reactions. Ocular side effects like trichomegaly and keratitis are also noted. When combined with chemotherapy, additional side effects such as mucositis, dysphagia, and systemic toxicities may occur.

What prior FDA approvals exist?

Cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor (EGFR), has been FDA-approved for the treatment of Squamous Cell Carcinoma of the head and neck. It is often used in combination with platinum-based chemotherapy and radiation therapy. Other related drugs include pembrolizumab and nivolumab, which are immune checkpoint inhibitors targeting the PD-1 pathway, approved for recurrent or metastatic SCC. These treatments aim to block tumor growth by targeting specific cellular pathways involved in cancer progression.

What other types of research exist?

Promising alternatives to cetuximab for SCC patients include monoclonal antibody K984, which has shown potential for tumor targeting and growth inhibition in SCC. Additionally, small molecule tyrosine kinase inhibitors like afatinib and gefitinib have been tested, although they have not yet demonstrated a significant increase in overall survival. Combination therapies, such as palbociclib with cetuximab, have also been explored, but further research is needed to establish their efficacy.

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Monoclonal Antibodies

Cetuximab for Skin Cancer

N/A

Waitlist Available

Led By Janice Mehnert

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well cetuximab works in patients with aggressive skin cancer. Cetuximab targets and blocks a protein on cancer cells, stopping them from growing. The goal is to shrink the tumor and make surgery easier.

Who is the study for?

This trial is for patients with aggressive, locally advanced skin cancer that hasn't spread to distant organs. Participants must be relatively fit (ECOG <=2), not pregnant, and willing to consent to treatment and biopsies. They should have a life expectancy of at least 12 weeks and cannot join if they have serious health issues, certain mineral imbalances, or allergies to cetuximab.

What is being tested?

The study tests the effects of cetuximab, a monoclonal antibody targeting cancer cells when given before surgery. The goal is to see if it can shrink tumors effectively enough to reduce the amount of normal tissue removed during surgery.

What are the potential side effects?

Cetuximab may cause side effects such as allergic reactions, skin rash, low magnesium levels in blood, difficulty breathing due to lung inflammation, abdominal pain from digestive tract irritation and fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response Rate of Cetuximab by RECIST Criteria

Secondary study objectives

Downstream Activation of Signaling Pathways Without a Known Driver, Including the EGFRpathway

Overall Survival

Potential Markers of Response and/or Resistance to Cetuximab Therapy

+1 more

Side effects data

From 2012 Phase 3 trial • 3397 Patients • NCT00079274

18%

Rash desquamating

18%

Nausea

16%

Rash acneiform

16%

Diarrhea

Neutrophil count decreased

Vomiting

Abdominal pain

Mucositis oral

Dyspnea

Pharyngeal examination abnormal

Vascular access complication

Hand-and-foot syndrome

Pharyngeal mucositis

Fatigue

Anorexia

Serum potassium decreased

Serum magnesium decreased

Peripheral sensory neuropathy

Cough

Hepatobiliary disease

Thrombosis

Gastrointestinal disorder

Alanine aminotransferase increased

Dehydration

Ileus

Blood glucose increased

Ear, nose and throat examination abnormal

Serum magnesium increased

Depression

Weight loss

Atrial fibrillation

Cardiac pain

Ischemia cerebrovascular

Hypersensitivity

Catheter related infection

Pneumonia

Skin infection

Sepsis

Febrile neutropenia

Arrhythmia supraventricular

Device related infection

Serum phosphate decreased

Pulmonary fibrosis

Hypotension

Thrombotic microangiopathy

Atrial flutter

Serum calcium decreased

Anxiety

Pneumonitis

100%

80%

60%

40%

20%

Study treatment Arm

Arm F (Combination Chemotherapy, Monoclonal Antibody)

Arm C (Combination Chemotherapy)

Arm E (Combination Chemotherapy, Monoclonal Antibody)

Arm D (Combination Chemotherapy, Monoclonal Antibody)

Arm G (Locally Directed Therapy)

Arm B (Combination Chemotherapy)

Arm A (Combination Chemotherapy)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (cetuximab)Experimental Treatment2 Interventions

Patients receive cetuximab IV over 60-120 minutes once weekly for 8 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

cetuximab

2000

Completed Phase 3

~7290

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Squamous Cell Carcinoma (SCC) include targeted therapies like cetuximab, which is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR). Cetuximab binds to EGFR on cancer cells, blocking growth signals and potentially reducing tumor size. It also enhances the immune system's ability to attack cancer cells through antibody-dependent cellular cytotoxicity (ADCC). These mechanisms are important for SCC patients as they offer a targeted approach to control aggressive tumor growth and improve surgical outcomes.

Cetuximab-induced natural killer cell cytotoxicity in head and neck squamous cell carcinoma cell lines: investigation of the role of cetuximab sensitivity and HPV status.Novel immune-modulating drugs for advanced head and neck cancer.Immunotherapy of head and neck cancer: current and future considerations.